OAK: A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02008227
• Collaborator: (none)
• Enrollment: 1,225
• Locations: 208
• Arms: 2
• Actual Duration (Months): 58
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Condition or Disease	Intervention/Treatment	Phase
Non-Squamous Non-Small Cell Lung Cancer	Drug: Atezolizumab; Drug: Docetaxel	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1225 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
• Actual Study Start Date: Mar 11, 2014
• Actual Primary Completion Date: Jul 7, 2016
• Actual Study Completion Date: Jan 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody Atezolizumab 1200 milligrams (mg) was administered via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.	Drug: Atezolizumab; 1200 mg IV infusion on Day 1 of each 21-day cycle; Other Names: Tecentriq
Active Comparator: Docetaxel Docetaxel 75 milligrams per meter square (mg/m^2) was administered via IV infusion on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first.	Drug: Docetaxel; 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Who Died: PP-ITT [Baseline until death due to any cause (up to approximately 2.25 years)]

2. Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP [Baseline until death due to any cause (up to approximately 2.25 years)]

   Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.

3. Overall Survival (OS): PP-ITT [Baseline until death due to any cause (up to approximately 2.25 years)]

   OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.

4. OS: TC1/2/3 or IC1/2/3 Subgroup of PP [Baseline until death due to any cause (up to approximately 2.25 years)]

   OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.

5. OS: SP-ITT [Baseline until death due to any cause (up to approximately 2.87 years)]

   OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.

6. OS: TC1/2/3 Or IC1/2/3 Subgroup of SP [Baseline until death from any cause (approximately 2.87 years)]

   OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.

7. OS: TC2/3 or IC2/3 Subgroup of SP [Baseline until death due to any cause (up to approximately 2.87 years)]

   OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.

8. OS: TC3 or IC3 Subgroup of SP [Baseline until death due to any cause (up to approximately 2.87 years)]

   OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.

Secondary Outcome Measures

1. Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT [Baseline up to PD or Death (up to approximately 2.25 years)]

   PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.

2. Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP [Baseline up to PD or Death (up to approximately 2.25 years)]

   PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.

3. Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

   PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.

4. PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

   PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.

5. Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

   Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.

6. Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

   Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.

7. Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT [From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

   DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.

8. DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP [From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)]

   DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.

9. Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab [Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])]

10. Maximum Observed Serum Atezolizumab Concentration (Cmax) [Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)]

11. Minimum Observed Serum Atezolizumab Concentration (Cmin) [Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)]

12. Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13) [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)]

    TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.

13. EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).

14. EORTC QLQ-C30 Questionnaire Score: Functional Subscales [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).

15. EORTC QLQ-C30 Questionnaire Score: GHS Scale [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).

16. EORTC QLQ-C30 Questionnaire Score: Symptom Subscale [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).

17. EORTC QLQ-LC13 Questionnaire Score: Alopecia [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.

18. EORTC QLQ-LC13 Questionnaire Score: Coughing [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.

19. EORTC QLQ-LC13 Questionnaire Score: Dysphagia [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.

20. EORTC QLQ-LC13 Questionnaire Score: Dyspnea [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.

21. EORTC QLQ-LC13 Questionnaire Score: Hemoptysis [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.

22. EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.

23. EORTC QLQ-LC13 Questionnaire Score: Pain in Chest [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.

24. EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.

25. EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.

26. EORTC QLQ-LC13 Questionnaire Score: Sore Mouth [Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)]

    QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.

27. PFS as Determined by Investigator Using RECIST v1.1: SP-ITT [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)]

    PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.

28. Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT [Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)]

    Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.

29. DOR as Determined by Investigator Using RECIST v1.1: SP ITT [From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)]

    DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC

• Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens

• Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent

• Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Known active or untreated central nervous system (CNS) metastases

• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome

• History of autoimmune disease

• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted

• Active hepatitis B or hepatitis C

• Prior treatment with docetaxel

• Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Blood/Cancer Ctr	Bakersfield	California	United States	93309
2	Roy & Patricia Disney Family Cancer Center	Burbank	California	United States	91505
3	St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr	Fullerton	California	United States	92835
4	Kaiser Permanente - Hayward	Hayward	California	United States	94545
5	Scripps Clinic; Hematology & Oncology	La Jolla	California	United States	92037-1027
6	Pacific Shores Medical Group	Long Beach	California	United States	90813
7	Univ of Calif, Los Angeles; Hematology/Oncology	Los Angeles	California	United States	90095
8	North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr	Northridge	California	United States	91328
9	Kaiser Permanente - Oakland	Oakland	California	United States	94611
10	TMPN/ Cancer Care Associates	Redondo Beach	California	United States	90277
11	Kaiser Permanente - Roseville	Roseville	California	United States	95661
12	Kaiser Permanente Sacramento Medical Center	Sacramento	California	United States	95814
13	UC Davis; Comprehensive Cancer Center	Sacramento	California	United States	95817
14	Kaiser Permanente - San Francisco (2238 Geary)	San Francisco	California	United States	94115
15	K. Permanente - San Jose	San Jose	California	United States	95119
16	Coastal Integrative Cancer Care	San Luis Obispo	California	United States	93401
17	Kaiser Permanente - San Marcos	San Marcos	California	United States	92069
18	K. Permanente - Santa Clara	Santa Clara	California	United States	95051
19	Central Coast Medical Oncology	Santa Maria	California	United States	93454
20	K. Permanente - S. San Fran	South San Francisco	California	United States	94080
21	Kaiser Permanente - Vallejo	Vallejo	California	United States	94589
22	K. Permanente - Walnut Creek	Walnut Creek	California	United States	94596
23	St. Mary's Hospital Regional Cancer Center	Grand Junction	Colorado	United States	81501
24	Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree	Lone Tree	Colorado	United States
25	Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)	Jacksonville	Florida	United States	32256
26	AMPM Research Clinic	Miami	Florida	United States	33145
27	Orlando Health Inc.	Orlando	Florida	United States	32806
28	Georgia Cancer Specialists	Atlanta	Georgia	United States	30341
29	Ingalls Memorial Hospital	Harvey	Illinois	United States	60426
30	Illinois Cancer Care	Peoria	Illinois	United States	61615
31	Quincy Medical Group	Quincy	Illinois	United States	62301
32	Hematology-Oncology; Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
33	New England Cancer Specialists	Scarborough	Maine	United States	04074
34	Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building	Detroit	Michigan	United States	48201
35	US Oncology Research at Minnesota Oncology	Minneapolis	Minnesota	United States	55404
36	University of Minnesota	Minneapolis	Minnesota	United States	55455
37	Billings Clinic; Research Center	Billings	Montana	United States	59101
38	Montana Cancer Specialists	Missoula	Montana	United States	59802
39	Oncology Hematology West Midwest	Omaha	Nebraska	United States	68130
40	Comprehensive Cancer Centers of Nevada	Henderson	Nevada	United States	89014
41	Comprehensive Cancer Centers of Nevada - Eastern Avenue	Las Vegas	Nevada	United States	89169
42	Summit Medical Center	Florham Park	New Jersey	United States	07932
43	Luckow Pavillion, Valley Hosp; Office of Clinical Trials	Paramus	New Jersey	United States	07652
44	San Juan Oncology Associates	Farmington	New Mexico	United States	87401
45	Roswell Park Cancer Inst.	Buffalo	New York	United States	14263
46	New York Oncology Hematology PC - Latham	Clifton Park	New York	United States	12065
47	Mid Ohio Onc Hematology Inc	Columbus	Ohio	United States	43219
48	Cancer Treatment Centers of America-Tulsa	Tulsa	Oklahoma	United States	74133
49	Willamette Valley Cancer Ctr - 520 Country Club	Eugene	Oregon	United States	97401-8122
50	Rhode Island Hospital	Providence	Rhode Island	United States	02903
51	Texas Onc-Central Austin CA Ct	Austin	Texas	United States	78731
52	The Methodist Cancer Center	Houston	Texas	United States	77030
53	Texas Oncology, P.A. - Tyler; Tyler Cancer Center	Tyler	Texas	United States	75702
54	Virginia Cancer Specialists, PC	Fairfax	Virginia	United States	22031
55	Virginia Oncology Associates	Norfolk	Virginia	United States	23502
56	Blue Ridge Cancer Care	Roanoke	Virginia	United States	24014
57	Northwest Medical Specialties	Tacoma	Washington	United States	98405
58	Northwest Cancer Specialists - Vancouver	Vancouver	Washington	United States	98684
59	Aurora Health Care; Patient Centered Research	Milwaukee	Wisconsin	United States	53215
60	Instituto Medico Rio Cuarto	Córdoba		Argentina
61	COIBA	Provincia De Buenos Aires		Argentina	B1884BBF
62	Instituto de Oncología de Rosario	Rosario		Argentina	S2000KZE
63	Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin	Innsbruck		Austria	6020
64	Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.	Salzburg		Austria	5020
65	Lkh Vöcklabruck; I. Abt. Für Innere Medizin	Vöcklabruck		Austria	4840
66	Hospital das Clinicas - UFRGS	Porto Alegre	RS	Brazil	90035-903
67	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
68	Windsor Regional Cancer Centre	Windsor	Ontario	Canada	N8W 2X3
69	Cite de La Sante de Laval; Hemato-Oncologie	Laval	Quebec	Canada	H7M 3L9
70	McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology	Montreal	Quebec	Canada	H3T 1E2
71	Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas	Recoleta		Chile	8420383
72	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco		Chile	4810469
73	ONCOCENTRO APYS; Oncología	Vina Del Mar		Chile	2520598
74	Helsinki University Central Hospital; Dep. of Pulmonary Medicine	Helsinki		Finland	00290
75	Oulu University Hospital; Oncology	Oulu		Finland	90029
76	Tampere University Hospital; Dept of Oncology	Tampere		Finland	33520
77	Institut Sainte Catherine	Avignon		France	84918
78	Hopital Jean Minjoz; Pneumologie	Besancon		France	25030
79	Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie	Bordeaux		France	33077
80	Centre Francois Baclesse	Caen		France	14076
81	Centre Hospitalier Intercommunal; Service de Pneumologie	Creteil		France	94010
82	Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie	Grenoble		France	38043
83	Centre Jean Bernard; Radiotherapie Chimiotherapie	Le Mans		France	72000
84	Centre Oscar Lambret	Lille		France	59020
85	Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique	Marseille		France	13915
86	Hopital Emile Muller;Pneumologie	Mulhouse		France	68070
87	Hopital Cochin; Unite Fonctionnelle D Oncologie	Paris		France	75014
88	Hopital Saint Louis; Oncologie Medicale	Paris		France	75475
89	GH Paris Saint Joseph; Pneumologie	Paris		France	75674
90	Hopital Tenon;Pneumologie	Paris		France	75970
91	Centre Hospitalier Lyon Sud; Pneumologie	Pierre Benite		France	69495
92	CH de la region d Annecy	Pringy		France	74374
93	Hopital de Pontchaillou; Service de Pneumologie	Rennes		France	35033
94	Centre Paul Strauss; Oncologie Medicale	Strasbourg		France	67065
95	Hopital Foch; Pneumologie	Suresnes		France	92151
96	Hia Sainte Anne; Pneumologie	Toulon		France	83041
97	Hopital Larrey; Pneumologie	Toulouse		France	31059
98	Helios Klinikum Emil von Behring GmbH	Berlin		Germany	14165
99	Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie	Frankfurt		Germany	60488
100	Asklepios-Fachkliniken Muenchen-Gauting; Onkologie	Gauting		Germany	82131
101	Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II	Halle		Germany	06120
102	Thoraxklinik Heidelberg gGmbH	Heidelberg		Germany	69126
103	Lungenklinik Hemer	Hemer		Germany	58675
104	Fachklinik für Lungenerkrankungen	Immenhausen		Germany	34376
105	Krankenhaus Merheim Lungenklinik	Köln		Germany	51109
106	Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie	Regensburg		Germany	93053
107	Uoa Sotiria Hospital; Oncology	Athens		Greece	115 27
108	University Hospital of Patras Medical Oncology	Patras		Greece	265 04
109	Thermi Clinic; Oncology Clinic	Thermi Thessalonikis		Greece	570 01
110	Grupo Angeles	Guatemala City		Guatemala	01015
111	Semmelweis Egyetem X; Pulmonologiai Klinika	Budapest		Hungary	1083
112	University of Pecs, I st Dept of Internal Medicine	Pecs		Hungary	7624
113	Tudogyogyintezet Torokbalint	Torokbalint		Hungary	2045
114	Azienda Ospedaliera San Giuseppe Moscati	Avellino	Campania	Italy	83100
115	Seconda Universita' Degli Studi; Divsione Di Oncologia Medica	Napoli	Campania	Italy	80131
116	Azienda Ospedaliera Univ Parma; Dept Oncologia Medica	Parma	Emilia-Romagna	Italy	43100
117	Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica	Aviano	Friuli-Venezia Giulia	Italy	33081
118	Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato	Udine	Friuli-Venezia Giulia	Italy	33100
119	Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna	Roma	Lazio	Italy	00168
120	Istituto Nazionale per la Ricerca sul Cancro di Genova	Genova	Liguria	Italy	16132
121	Irccs Ospedale San Raffaele;Oncologia Medica	Milano	Lombardia	Italy	20132
122	Istituto Europeo Di Oncologia	Milano	Lombardia	Italy	20141
123	ASST DI MONZA; Oncologia Medica	Monza	Lombardia	Italy	20900
124	Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica	Bari	Puglia	Italy	70124
125	POLICLINICO RODOLICO, U.O. di Oncologia Medica	Catania	Sicilia	Italy	95100
126	Ospedale San Luca; Oncologia	Lucca	Toscana	Italy	55100
127	A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii	Pisa	Toscana	Italy	56124
128	IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda	Padova	Veneto	Italy	35128
129	A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina	Verona	Veneto	Italy	37134
130	Aichi Cancer Center Hospital; Respiratory Medicine	Aichi		Japan	464-8681
131	National Cancer Center Hospital East; Thoracic Oncology	Chiba		Japan	277-8577
132	National Hospital Organization Shikoku Cancer Center; Internal Medicine	Ehime		Japan	791-0280
133	National Hospital Organization Kyushu Cancer Center, Thoracic Oncology	Fukuoka		Japan	811-1395
134	Kobe City Medical Center General Hospital; Respiratory Medicine	Hyogo		Japan	650-0047
135	Hyogo Cancer Center; Thoracic Oncology	Hyogo		Japan	673-8558
136	Miyagi Cancer Center; Respiratory Medicine	Miyagi		Japan	981-1293
137	Okayama University Hospital; Respiratory and Allergy Medicine	Okayama		Japan	700-8558
138	Kindai University Hospital; Medical Oncology	Osaka		Japan	589-8511
139	National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine	Osaka		Japan	591-8555
140	Saitama Cancer Center; Thoracic Oncology	Saitama		Japan	362-0806
141	Shizuoka Cancer Center; Thoracic Oncology	Shizuoka		Japan	411-8777
142	National Cancer Center Hospital; Thoracic Medical Oncology	Tokyo		Japan	104-0045
143	The Cancer Institute Hospital of JFCR, Respiratory Medicine	Tokyo		Japan	135-8550
144	Tokyo Medical University Hospital; Dept of Surgery	Tokyo		Japan	160-0023
145	National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine	Yamaguchi		Japan	755-0241
146	National Cancer Center; Medical Oncology	Gyeonggi-do		Korea, Republic of	410-769
147	Seoul National University Bundang Hospital; Hematology Medical Oncology	Gyeonggi-do		Korea, Republic of	463-707
148	Seoul National Uni Hospital; Internal Medicine	Seoul		Korea, Republic of	03080
149	Yonsei University Severance Hospital; Medical Oncology	Seoul		Korea, Republic of	120-752
150	Samsung Medical Center; Gastroenterology	Seoul		Korea, Republic of	135-710
151	Seoul St.Mary's Hospital; Medical Oncology	Seoul		Korea, Republic of	137-807
152	Jeroen Bosch Ziekenhuis	'S Hertogenbosch		Netherlands	5223 GZ
153	Catharina Ziekenhuis; Dept of Lung Diseases	Eindhoven		Netherlands	5623 EJ
154	Antonius Ziekenhuis; Dept of Lung Diseases	Nieuwegein		Netherlands	3435 CM
155	Auckland city hospital; Auckland Regional Cancer Centre and Blood Service	Auckland		New Zealand	1023
156	Dunedin Hospital	Dunedin		New Zealand
157	Waikato Hospital; Dept of Medical Oncology	Hamilton		New Zealand	3240
158	Oslo Universitetssykehus HF; Radiumhospitalet	Oslo		Norway	0310
159	Centro Hemato Oncologico Panama	Panama		Panama	0832
160	Medical University of Gdansk	Gdansk		Poland	80-952
161	Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii	Lodz		Poland	93-513
162	Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii	Otwock		Poland	05-400
163	Med.-Polonia Sp. z o.o. NSZOZ	Poznan		Poland	60-693
164	Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii	Warszawa		Poland	02-781
165	Hospital Geral; Servico de Pneumologia	Coimbra		Portugal	3041-801
166	Hospital Pulido Valente; Servico de Pneumologia	Lisboa		Portugal	1796-001
167	IPO do Porto; Servico de Oncologia Medica	Porto		Portugal	4200-072
168	N.N.Burdenko Main Military Clinical Hospital; Oncology Dept	Moscow		Russian Federation	105229
169	City Clinical Onc.	Saint-Petersburg		Russian Federation	198255
170	SBI of Healthcare Samara Regional Clinical Oncology Dispensary	Samara		Russian Federation	443031
171	Clinic for Pulmonology, Clinical Center of Serbia	Belgrade		Serbia	11000
172	Institute for pulmonary diseases of Vojvodina	Sremska Kamenica		Serbia	21204
173	Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia	Las Palmas de Gran Canaria	LAS Palmas	Spain	35016
174	Hospital Universitario Puerta de Hierro; Servicio de Oncologia	Majadahonda	Madrid	Spain	28222
175	Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología	La Coruña		Spain	15006
176	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid		Spain	28034
177	Fundacion Jimenez Diaz; Servicio de Oncologia	Madrid		Spain	28040
178	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Madrid		Spain	28040
179	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid		Spain	28041
180	Hospital Universitario La Paz; Servicio de Oncologia	Madrid		Spain	28046
181	Hospital Regional Universitario Carlos Haya; Servicio de Oncologia	Malaga		Spain	29010
182	Hospital Universitario Miguel Servet; Servicio Oncologia	Zaragoza		Spain	50009
183	Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken	Goeteborg		Sweden	41345
184	Universitetssjukhuset Linköping; Lungmedicinkliniken	Linköping		Sweden	581 85
185	Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02	Stockholm		Sweden	171 76
186	Kantonsspital Baden; Medizinische Klinik, Onkologie	Baden		Switzerland	5404
187	HUG; Oncologie	Geneve		Switzerland	1211
188	Luzerner Kantonsspital; Medizinische Onkologie	Luzern		Switzerland	6004
189	China Medical University Hospital	Taichung		Taiwan	40447
190	National Taiwan Uni Hospital; Internal Medicine	Taipei		Taiwan	100
191	Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology	Taipei		Taiwan	112
192	Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology	Taoyuan		Taiwan	333
193	Chulalongkorn Hospital; Medical Oncology	Bangkok		Thailand	10330
194	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok		Thailand	10400
195	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok		Thailand	10700
196	Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology	Istanbul		Turkey	34300
197	Izmir Suat Seren Chest Diseases and Surgery Research Hospital	Izmir		Turkey	35110
198	State Medical Academy; Oncology	Dnipropetrovsk		Ukraine	43102
199	Karkiv Regional Oncology Center	Kharkiv		Ukraine	61070
200	Uzhgorod Nat. University Central Municip Hosp; Onc Center	Uzhgorod		Ukraine	88000
201	Diana Princess of Wales Hosp.	Grimsby		United Kingdom	DN33 2BA
202	University College London Hospital	London		United Kingdom	NW1 - 2PG
203	Royal Free Hospital	London		United Kingdom	NW3 2QS
204	Guys and St Thomas NHS Foundation Trust, Guys Hospital	London		United Kingdom	SE1 9RT
205	St George's Hospital	London		United Kingdom	SW17 0QT
206	Charing Cross Hospital	London		United Kingdom	W6 8RF
207	Christie Hospital NHS Trust	Manchester		United Kingdom	M20 4BX
208	Kings Mill Hospital	Sutton in Ashfield		United Kingdom	NG17 4JL

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT02008227
• Other Study ID Numbers: GO28915; 2013-003331-30
• First Posted: Dec 11, 2013
• Last Update Posted: Dec 20, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Docetaxel; Atezolizumab

Study Results

Participant Flow

Pre-assignment Detail	Twelve hundred and twenty-five participants were randomized in the study and were considered the Secondary Population (SP), out of which first 850 randomized participants were considered the Primary Population (PP).

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 milligrams (mg) was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Period Title: Overall Study
STARTED	612	613
Treated	579	608
COMPLETED	0	0
NOT COMPLETED	612	613

Baseline Characteristics

Arm/Group Title	Docetaxel	Atezolizumab	Total
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Total of all reporting groups
Overall Participants	612	613	1225
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	62.9 (9.2)	62.7 (9.8)	62.8 (9.5)
Sex: Female, Male (Count of Participants)
Female	233 38.1%	234 38.2%	467 38.1%
Male	379 61.9%	379 61.8%	758 61.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	42 6.9%	48 7.8%	90 7.3%
Not Hispanic or Latino	541 88.4%	540 88.1%	1081 88.2%
Unknown or Not Reported	29 4.7%	25 4.1%	54 4.4%
Race/Ethnicity, Customized (Number) [Number]
American Indian or Alaska Native	2 0.3%	1 0.2%	3 0.2%
Asian	125 20.4%	124 20.2%	249 20.3%
Black or African American	16 2.6%	11 1.8%	27 2.2%
Native Hawaiian or other Pacific Islander	2 0.3%	3 0.5%	5 0.4%
White	432 70.6%	438 71.5%	870 71%
Other	12 2%	11 1.8%	23 1.9%
Multiple	1 0.2%	2 0.3%	3 0.2%
Unknown	22 3.6%	23 3.8%	45 3.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Died: PP-ITT
Time Frame	Baseline until death due to any cause (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

PP-ITT analysis set included the first 850 randomized ITT participants regardless of whether they received any study drug.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Number [Percentage of Participants]	70.1 11.5%	63.8 10.4%

2. Primary Outcome

Title	Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
Description	Percentage of participants who died among TC1/2/3 or IC1/2/3 subgroup of PP-ITT were reported. TC1 = presence of discernible programmed death-ligand 1 (PD-L1) staining of any intensity in >/=1% and <5% TCs; TC2: presence of discernible PD-L1 staining of any intensity in >/=5% and <50% TCs; TC3 = presence of discernible PD-L1 staining of any intensity in >/=50% TCs; IC1 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=1% and <5% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC2 = presence of discernible PD-L1 staining of any intensity in ICs covering between >/=5% and <10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma; IC3 = presence of discernible PD-L1 staining of any intensity in ICs covering >/=10% of tumor area occupied by tumor cells, associated intratumoral, and contiguous peri-tumoral desmoplastic stroma.
Time Frame	Baseline until death due to any cause (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

TC1/2/3 or IC1/2/3 subgroup within PP included ITT participants with the corresponding programmed death-ligand 1 (PD-L1) expression status.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	222	241
Number [Percentage of Participants]	67.1 11%	62.7 10.2%

3. Primary Outcome

Title	Overall Survival (OS): PP-ITT
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Median (95% Confidence Interval) [Months]	9.6	13.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 95%; 0.62 to 0.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	OS: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	222	241
Median (95% Confidence Interval) [Months]	10.3	15.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0102
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0052
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.58 to 0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
Description	PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeters (mm), or presence of new lesions.
Time Frame	Baseline up to PD or Death (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Number [Percentage of Participants]	88.2 14.4%	89.4 14.6%

6. Secondary Outcome

Title	Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame	Baseline up to PD or Death (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	222	241
Number [Percentage of Participants]	86.9 14.2%	89.6 14.6%

7. Secondary Outcome

Title	Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
Description	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Median (95% Confidence Interval) [Months]	4.0	2.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.4928
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.82 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3596
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.93
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	222	241
Median (95% Confidence Interval) [Months]	4.1	2.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3806
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3249
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
Description	Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Number (95% Confidence Interval) [Percentage of Participants]	13.4 2.2%	13.6 2.2%

10. Secondary Outcome

Title	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	Objective response is defined as a CR or PR as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	222	241
Number (95% Confidence Interval) [Percentage of Participants]	16.2 2.6%	17.8 2.9%

11. Secondary Outcome

Title	Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
Description	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Time Frame	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	57	58
Median (95% Confidence Interval) [Months]	6.2	16.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95%; 0.18 to 0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; 0.21 to 0.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
Description	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Time Frame	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)

Outcome Measure Data

Analysis Population Description

The TC1/2/3 or IC1/2/3 subgroup of PP

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	36	43
Median (95% Confidence Interval) [Months]	6.2	16.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95%; 0.15 to 0.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.38
	Confidence Interval	(2-Sided) 95%; 0.22 to 0.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
Time Frame	Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])

Outcome Measure Data

Analysis Population Description

ATA evaluable population included all participants who received atezolizumab treatment and had at least one post treatment ATA result.

Arm/Group Title	Atezolizumab
Arm/Group Description	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	565
Number [Percentage of Participants]	30.4 5%

14. Secondary Outcome

Title	Maximum Observed Serum Atezolizumab Concentration (Cmax)
Time Frame	Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) evaluable population included participants who received atezolizumab treatment and had at least one measurable PK concentration.

Arm/Group Title	Atezolizumab
Arm/Group Description	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	606
Mean (Standard Deviation) [Microgram per milliliter (mcg/mL)]	400 (127)

15. Secondary Outcome

Title	Minimum Observed Serum Atezolizumab Concentration (Cmin)
Time Frame	Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)

Outcome Measure Data

Analysis Population Description

PK evaluable participants. Here, 'n' signifies those participants evaluated for this measure at specific time point. All 606 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Atezolizumab
Arm/Group Description	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	606
C1D1 (n= 593)	2.59 (30.9)
C2D1 (n= 534)	83.2 (31.0)
C3D1 (n= 445)	130 (55.8)
C4D1 (n= 405)	158 (66.4)
C8D1 (n= 222)	205 (99.4)
C16D1 (n= 132)	226 (105)
C24D1 (n= 63)	250 (99.8)
C32D1 (n= 11)	277 (117)
EOT (n= 347)	144 (101)
120 days after EOT (n= 124)	10.4 (20.0)

16. Secondary Outcome

Title	Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
Description	TTD in patient-reported lung cancer symptoms (pain in chest or in arm/shoulder, dyspnea, or cough) was a composite endpoint defined as the time from randomization to the earliest time the participant's scale scores showed a 10 point or greater increase after baseline in any of the symptoms. A >/=10-point change in the score perceived by participants was considered as clinically significant. The QLQ-LC13 consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Pain in Chest	8.3	18.0
Cough	5.6	5.5
Dyspnea	2.1	1.8
Arm/Shoulder Pain	6.2	8.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Pain in Chest: Stratified analysis based on the strata of IC levels per IxRS, the number of prior chemotherapy regimens per IxRS, and histology per eCRF.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0111
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.72
	Confidence Interval	(2-Sided) 95%; 0.55 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Cough: Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6305
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.84 to 1.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Dyspnea: Unstratified Analysis
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.7406
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Arm/Shoulder Pain
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.5221
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
Description	EORTC QLQ-C30 included global health status (GHS)/quality of life (QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Appetite Loss: Baseline (n= 390, 413)	26.58 (31.57)	22.92 (29.41)
Appetite Loss: Cycle (C) 2 Day (D) 1(n= 342, 368)	27.49 (30.39)	26.99 (31.16)
Appetite Loss: C3D1(n= 256, 304)	21.35 (28.84)	21.16 (28.94)
Appetite Loss: C4D1(n= 224, 279)	18.75 (25.36)	18.40 (26.60)
Appetite Loss: C5D1(n= 166, 238)	18.88 (23.89)	16.67 (27.52)
Appetite Loss: C6D1(n= 151, 224)	18.98 (25.68)	14.88 (25.39)
Appetite Loss: C7D1(n= 88, 190)	15.91 (24.75)	12.46 (23.06)
Appetite Loss: C8D1(n= 72, 170)	13.89 (22.20)	12.94 (23.27)
Appetite Loss: C9D1(n= 50, 153)	8.00 (18.52)	11.33 (22.35)
Appetite Loss: C10D1(n= 47, 146)	7.80 (15.87)	12.33 (21.45)
Appetite Loss: C11D1(n= 37, 134)	11.71 (23.85)	11.44 (22.43)
Appetite Loss: C12D1(n= 30, 132)	11.11 (20.22)	8.84 (18.81)
Appetite Loss: C13D1(n= 19, 123)	10.53 (15.92)	8.40 (15.74)
Appetite Loss: C14D1(n= 18, 120)	7.41 (14.26)	10.00 (17.61)
Appetite Loss: C15D1(n= 16, 113)	6.25 (13.44)	12.39 (22.80)
Appetite Loss: C16D1(n= 13, 109)	7.69 (14.62)	10.09 (19.51)
Appetite Loss: C17D1(n= 11, 98)	6.06 (13.48)	7.82 (18.41)
Appetite Loss: C18D1(n= 10, 91)	6.67 (14.05)	8.06 (18.15)
Appetite Loss: C19D1(n= 9, 84)	7.41 (14.70)	9.13 (18.18)
Appetite Loss: C20D1(n= 9, 80)	11.11 (23.57)	9.58 (21.34)
Appetite Loss: C21D1(n= 9, 75)	3.70 (11.11)	12.44 (26.15)
Appetite Loss: C22D1(n= 8, 69)	8.33 (15.43)	6.76 (16.74)
Appetite Loss: C23D1(n= 8, 66)	8.33 (15.43)	7.58 (17.34)
Appetite Loss: C24D1(n= 5, 64)	13.33 (18.26)	8.33 (15.71)
Appetite Loss: C25D1(n= 3, 60)	0.00 (0.00)	6.11 (13.01)
Appetite Loss: C26D1(n= 3, 55)	22.22 (19.24)	5.45 (12.45)
Appetite Loss: C27D1(n= 3, 52)	0.00 (0.00)	9.62 (19.06)
Appetite Loss: C28D1(n= 1, 49)	0.00 (NA)	7.48 (15.61)
Appetite Loss: C29D1(n= 2, 40)	33.33 (47.14)	9.17 (16.86)
Appetite Loss: C30D1(n= 1, 31)	0.00 (NA)	1.08 (5.99)
Appetite Loss: C31D1(n= 0, 24)	NA (NA)	6.94 (13.83)
Appetite Loss: C32D1(n= 0, 22)	NA (NA)	7.58 (22.84)
Appetite Loss: C33D1(n= 0,16)	NA (NA)	8.33 (25.82)
Appetite Loss: C34D1(n= 0, 14)	NA (NA)	4.76 (17.82)
Appetite Loss: C35D1(n= 0, 12)	NA (NA)	8.33 (20.72)
Appetite Loss: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Appetite Loss: C37D1(n= 0, 5)	NA (NA)	6.67 (14.91)
Appetite Loss: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Appetite Loss: End of treatment (EOT)(n= 265, 246)	29.81 (31.85)	31.98 (33.51)
Appetite Loss: Pro Week 6 Pd(n= 0,1)	NA (NA)	33.33 (NA)
Appetite Loss: Survival Follow-up (FU) 1 (n= 2, 1)	50.00 (70.71)	66.67 (NA)
Constipation: Baseline (n= 388, 410)	19.93 (27.39)	16.50 (26.81)
Constipation: C2D1(n= 339, 363)	19.47 (26.42)	18.09 (26.92)
Constipation: C3D1(n= 255, 304)	19.74 (26.91)	15.13 (23.71)
Constipation: C4D1(n= 224, 277)	17.86 (23.38)	14.56 (23.58)
Constipation: C5D1(n= 166, 236)	13.05 (21.33)	12.15 (21.16)
Constipation: C6D1(n= 151, 225)	14.35 (23.89)	12.89 (22.42)
Constipation: C7D1(n= 87, 188)	13.41 (20.62)	11.52 (21.04)
Constipation: C8D1(n= 72, 171)	8.33 (15.57)	12.28 (21.36)
Constipation: C9D1(n= 50, 153)	9.33 (19.10)	10.68 (17.79)
Constipation: C10D1(n= 47, 146)	9.22 (17.99)	9.82 (17.58)
Constipation: C11D1(n= 37, 134)	5.41 (12.46)	9.95 (17.83)
Constipation: C12D1(n= 30, 132)	11.11 (20.22)	10.86 (18.65)
Constipation: C13D1(n= 19, 124)	5.26 (12.49)	8.60 (15.83)
Constipation: C14D1(n= 17, 121)	15.69 (23.91)	9.09 (16.67)
Constipation: C15D1(n= 15, 113)	2.22 (8.61)	10.03 (17.75)
Constipation: C16D1(n= 13, 109)	20.51 (32.03)	9.79 (18.87)
Constipation: C17D1(n= 11, 98)	12.12 (22.47)	9.86 (19.27)
Constipation: C18D1(n= 10, 92)	6.67 (14.05)	9.06 (17.89)
Constipation: C19D1(n= 9, 83)	7.41 (14.70)	9.64 (18.43)
Constipation: C20D1(n=9, 80)	14.81 (33.79)	12.50 (23.35)
Constipation: C21D1(n= 9, 75)	7.41 (14.70)	14.22 (25.22)
Constipation: C22D1(n= 8, 69)	12.50 (24.80)	11.59 (21.26)
Constipation: C23D1(n= 8, 66)	4.17 (11.78)	10.10 (20.23)
Constipation: C24D1(n=5, 65)	20.00 (29.81)	9.74 (17.40)
Constipation: C25D1(n= 3, 60)	0.00 (0.00)	11.11 (19.08)
Constipation: C26D1(n= 2, 55)	0.00 (0.00)	12.12 (20.65)
Constipation: C27D1(n= 3, 52)	0.00 (0.00)	13.46 (20.09)
Constipation: C28D1(n= 1, 48)	0.00 (NA)	11.81 (22.27)
Constipation: C29D1(n= 2, 40)	50.00 (70.71)	15.83 (23.86)
Constipation: C30D1(n= 1, 31)	0.00 (NA)	8.60 (19.18)
Constipation: C31D1(n= 0, 24)	NA (NA)	9.72 (20.80)
Constipation: C32D1(n= 0, 22)	NA (NA)	6.06 (13.16)
Constipation: C33D1(n= 0, 16)	NA (NA)	4.17 (11.39)
Constipation: C34D1(n= 0, 14)	NA (NA)	7.14 (14.19)
Constipation: C35D1(n= 0, 12)	NA (NA)	5.56 (12.97)
Constipation: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Constipation: C37D1(n= 0, 5)	NA (NA)	0.00 (0.00)
Constipation: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Constipation: EOT (n= 265, 246)	19.12 (27.28)	19.78 (28.36)
Constipation: Pro Week 6 Pd(n= 0,1)	NA (NA)	66.67 (NA)
Constipation: Survival FU-1 (n= 2,1)	33.33 (47.14)	66.67 (NA)
Diarrhea: Baseline (n= 388, 411)	5.84 (13.77)	7.22 (17.86)
Diarrhea: C2D1(n= 339, 361)	11.21 (20.65)	7.29 (17.72)
Diarrhea: C3D1(n= 255, 304)	10.07 (18.68)	6.14 (15.75)
Diarrhea: C4D1(n= 223, 280)	8.22 (16.35)	6.67 (17.71)
Diarrhea: C5D1(n= 166, 238)	8.43 (17.48)	6.58 (16.16)
Diarrhea: C6D1(n= 151, 222)	7.51 (14.99)	6.31 (14.88)
Diarrhea: C7D1(n= 87, 189)	10.34 (17.10)	7.94 (17.24)
Diarrhea: C8D1(n= 72, 171)	7.41 (15.03)	8.77 (17.56)
Diarrhea: C9D1(n= 50, 153)	11.33 (17.31)	7.63 (16.44)
Diarrhea: C10D1(n= 47, 146)	7.80 (14.27)	5.48 (15.67)
Diarrhea: C11D1(n= 36, 134)	8.33 (14.64)	4.98 (14.46)
Diarrhea: C12D1(n= 30, 132)	10.00 (17.83)	6.31 (16.54)
Diarrhea: C13D1(n= 18, 124)	11.11 (16.17)	5.65 (14.55)
Diarrhea: C14D1(n= 17, 121)	3.92 (11.07)	9.92 (19.07)
Diarrhea: C15D1(n= 15, 113)	8.89 (15.26)	7.96 (17.97)
Diarrhea: C16D1(n= 12, 108)	13.89 (17.16)	6.48 (14.02)
Diarrhea: C17D1(n= 11, 98)	9.09 (15.57)	7.82 (16.44)
Diarrhea: C18D1(n= 10, 92)	13.33 (17.21)	8.70 (17.73)
Diarrhea: C19D1(n= 9, 84)	14.81 (17.57)	7.94 (18.38)
Diarrhea: C20D1(n= 9, 80)	7.41 (14.70)	6.67 (14.43)
Diarrhea: C21D1(n= 9, 75)	18.52 (17.57)	11.11 (18.45)
Diarrhea: C22D1(n= 8, 68)	16.67 (25.20)	7.84 (16.41)
Diarrhea: C23D1(n= 8, 66)	8.33 (15.43)	6.06 (16.44)
Diarrhea: C24D1(n= 5, 64)	6.67 (14.91)	6.25 (16.67)
Diarrhea: C25D1(n= 3, 60)	0.00 (0.00)	6.11 (14.38)
Diarrhea: C26D1(n= 3, 55)	11.11 (19.24)	10.30 (21.15)
Diarrhea: C27D1(n= 3, 52)	11.11 (19.24)	5.77 (15.79)
Diarrhea: C28D1(n= 1, 48)	0.00 (NA)	4.86 (13.73)
Diarrhea: C29D1(n= 2, 40)	50.00 (70.71)	9.17 (18.47)
Diarrhea: C30D1(n= 1, 31)	0.00 (NA)	7.53 (16.58)
Diarrhea: C31D1(n= 0, 24)	NA (NA)	6.94 (16.97)
Diarrhea: C32D1(n= 0, 22)	NA (NA)	12.12 (16.41)
Diarrhea: C33D1(n= 0, 16)	NA (NA)	8.33 (14.91)
Diarrhea: C34D1(n= 0, 14)	NA (NA)	4.76 (12.10)
Diarrhea: C35D1(n= 0, 12)	NA (NA)	5.56 (12.97)
Diarrhea: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Diarrhea: C37D1(n= 0, 5)	NA (NA)	6.67 (14.91)
Diarrhea: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Diarrhea: EOT(n= 265, 246)	10.57 (19.18)	9.35 (20.39)
Diarrhea: Pro Week 6 Pd(n= 0, 1)	NA (NA)	0.00 (NA)
Diarrhea: Survival FU-1 (n= 2, 1)	33.33 (47.14)	33.33 (NA)
Financial Difficulties: Baseline (n=387, 411)	20.76 (27.61)	18.09 (28.32)
Financial Difficulties: C2D1 (n=336, 362)	18.45 (26.20)	15.93 (26.28)
Financial Difficulties: C3D1 (n=253, 305)	16.86 (24.24)	15.63 (25.79)
Financial Difficulties: C4D1 (n=219, 280)	16.74 (23.97)	15.12 (24.72)
Financial Difficulties: C5D1 (n=165, 238)	16.57 (24.03)	15.13 (25.71)
Financial Difficulties: C6D1 (n=149, 224)	15.66 (24.06)	16.67 (26.41)
Financial Difficulties: C7D1 (n=86, 189)	16.28 (24.92)	17.46 (27.41)
Financial Difficulties: C8D1 (n=71, 170)	13.15 (21.44)	18.82 (27.59)
Financial Difficulties: C9D1 (n=49, 152)	16.33 (28.16)	17.54 (27.38)
Financial Difficulties: C10D1 (n=46, 146)	14.49 (23.99)	17.81 (29.08)
Financial Difficulties: C11D1 (n=36, 134)	9.26 (21.98)	19.65 (30.10)
Financial Difficulties: C12D1 (n=30, 132)	12.22 (23.95)	18.43 (28.92)
Financial Difficulties: C13D1 (n=18, 122)	12.96 (25.92)	18.31 (29.10)
Financial Difficulties: C14D1 (n=17, 121)	15.69 (26.66)	18.46 (29.17)
Financial Difficulties: C15D1 (n=15, 113)	6.67 (18.69)	18.29 (28.86)
Financial Difficulties: C16D1 (n=12, 109)	13.89 (30.01)	18.65 (29.20)
Financial Difficulties: C17D1 (n=11, 98)	15.15 (22.92)	18.37 (27.55)
Financial Difficulties: C18D1 (n=10, 92)	10.00 (22.50)	19.57 (28.45)
Financial Difficulties: C19D1 (n=9, 84)	3.70 (11.11)	19.05 (28.94)
Financial Difficulties: C20D1 (n=9, 80)	11.11 (33.33)	18.75 (27.99)
Financial Difficulties: C21D1 (n=9, 75)	11.11 (33.33)	23.11 (30.99)
Financial Difficulties: C22D1 (n=8, 68)	12.50 (35.36)	18.63 (28.44)
Financial Difficulties: C23D1 (n=7, 66)	9.52 (25.20)	21.72 (30.66)
Financial Difficulties: C24D1 (n=5, 64)	13.33 (29.81)	20.83 (29.99)
Financial Difficulties: C25D1 (n=3, 60)	0.00 (0.00)	21.67 (31.19)
Financial Difficulties: C26D1 (n=3, 55)	0.00 (0.00)	20.00 (30.50)
Financial Difficulties: C27D1 (n=3, 52)	0.00 (0.00)	17.31 (28.38)
Financial Difficulties: C28D1 (n=1, 48)	0.00 (NA)	18.06 (26.59)
Financial Difficulties: C29D1 (n=2, 40)	50.00 (70.71)	19.17 (28.13)
Financial Difficulties: C30D1 (n=1, 31)	0.00 (NA)	17.20 (25.63)
Financial Difficulties: C31D1(n=0, 24)	NA (NA)	20.83 (25.66)
Financial Difficulties: C32D1(n=0, 22)	NA (NA)	21.21 (26.32)
Financial Difficulties: C33D1(n=0, 16)	NA (NA)	22.92 (29.11)
Financial Difficulties: C34D1(n=0, 14)	NA (NA)	26.19 (35.03)
Financial Difficulties: C35D1(n=0, 12)	NA (NA)	27.78 (37.15)
Financial Difficulties: C36D1(n=0, 8)	NA (NA)	8.33 (15.43)
Financial Difficulties: C37D1(n=0, 5)	NA (NA)	26.67 (43.46)
Financial Difficulties: C38D1(n=0, 2)	NA (NA)	16.67 (23.57)
Financial Difficulties: EOT(n=263, 245)	21.80 (29.23)	19.46 (28.75)
Financial Difficulties: Pro Week 6 Pd (n=0, 1)	NA (NA)	33.33 (NA)
Financial Difficulties:Survival FU-1 (n=2,24)	83.33 (23.57)	66.67 (NA)
Insomnia: Baseline (n= 388, 413)	28.87 (30.55)	26.15 (28.72)
Insomnia: C2D1(n= 340, 367)	27.55 (30.87)	26.52 (28.61)
Insomnia: C3D1(n= 253, 304)	25.69 (29.15)	24.89 (27.32)
Insomnia: C4D1(n= 222, 279)	21.32 (26.07)	23.66 (26.48)
Insomnia: C5D1(n= 166, 237)	21.49 (25.43)	25.88 (29.84)
Insomnia: C6D1(n= 150, 225)	22.00 (26.71)	23.41 (27.73)
Insomnia: C7D1(n= 87, 189)	21.07 (25.47)	23.99 (26.65)
Insomnia: C8D1(n= 70, 169)	15.24 (23.87)	23.87 (26.27)
Insomnia: C9D1(n= 49, 153)	16.33 (26.46)	22.88 (27.16)
Insomnia: C10D1(n= 46, 144)	13.77 (19.34)	21.53 (26.87)
Insomnia: C11D1(n= 36, 133)	9.26 (18.87)	20.55 (27.44)
Insomnia: C12D1(n= 29, 132)	16.09 (30.37)	21.46 (24.41)
Insomnia: C13D1(n= 17, 124)	17.65 (29.15)	23.39 (28.51)
Insomnia: C14D1(n= 17, 121)	25.49 (27.71)	23.69 (26.33)
Insomnia: C15D1(n= 15, 113)	22.22 (29.99)	21.53 (28.84)
Insomnia: C16D1(n= 13, 108)	20.51 (25.60)	21.60 (31.01)
Insomnia: C17D1(n= 11, 98)	21.21 (26.97)	20.07 (28.21)
Insomnia: C18D1(n= 10, 92)	20.00 (32.20)	21.38 (27.77)
Insomnia: C19D1(n= 9, 83)	18.52 (24.22)	22.49 (28.09)
Insomnia: C20D1(n= 9, 80)	18.52 (33.79)	20.83 (29.71)
Insomnia: C21D1(n= 9, 75)	22.22 (33.33)	20.89 (29.90)
Insomnia: C22D1(n= 8, 69)	16.67 (35.63)	18.84 (26.49)
Insomnia: C23D1(n= 8, 66)	20.83 (35.36)	19.70 (28.03)
Insomnia: C24D1(n= 5, 64)	26.67 (27.89)	19.79 (25.00)
Insomnia: C25D1(n= 3, 60)	11.11 (19.24)	18.89 (23.26)
Insomnia: C26D1(n= 3, 55)	11.11 (19.24)	21.21 (27.49)
Insomnia: C27D1(n= 3, 52)	11.11 (19.24)	19.23 (28.27)
Insomnia: C28D1(n= 1, 49)	0.00 (NA)	21.09 (27.80)
Insomnia: C29D1(n= 2, 40)	33.33 (47.14)	21.67 (26.74)
Insomnia: C30D1(n= 1, 31)	0.00 (NA)	20.43 (28.12)
Insomnia: C31D1(n= 0, 24)	NA (NA)	20.83 (27.47)
Insomnia: C32D1(n= 0, 22)	NA (NA)	19.70 (26.55)
Insomnia: C33D1(n= 0, 16)	NA (NA)	20.83 (34.16)
Insomnia: C34D1(n= 0, 14)	NA (NA)	23.81 (24.21)
Insomnia: C35D1(n= 0, 12)	NA (NA)	25.00 (28.87)
Insomnia: C36D1(n= 0, 8)	NA (NA)	25.00 (23.57)
Insomnia: C37D1(n= 0, 5)	NA (NA)	33.33 (23.57)
Insomnia: C38D1(n= 0, 2)	NA (NA)	16.67 (23.57)
Insomnia: EOT(n= 264, 246)	28.91 (30.65)	29.95 (30.30)
Insomnia: Pro Week Pd(n= 0, 1)	NA (NA)	66.67 (NA)
Insomnia: Survival FU-1 (n= 2, 1)	50.00 (70.71)	100.00 (NA)
Dyspnea: C1D1 (n= 389, 412)	33.50 (31.11)	32.04 (28.73)
Dyspnea: C2D1 (n= 341, 368)	32.55 (29.03)	31.88 (29.70)
Dyspnea: C3D1 (n= 255, 302)	29.93 (27.54)	27.15 (26.73)
Dyspnea: C4D1 (n= 389, 277)	28.38 (24.37)	28.28 (27.48)
Dyspnea: C5D1 (n= 222, 236)	29.52 (24.46)	27.82 (27.03)
Dyspnea: C6D1 (n= 166, 222)	30.02 (26.32)	26.88 (25.63)
Dyspnea: C7D1 (n= 151, 188)	27.13 (25.31)	25.53 (25.99)
Dyspnea: C8D1 (n= 86, 169)	28.70 (29.76)	26.43 (26.70)
Dyspnea: C9D1 (n= 72, 152)	26.67 (28.57)	24.12 (24.92)
Dyspnea: C10D1 (n= 50, 146)	27.66 (28.93)	23.52 (23.54)
Dyspnea: C11D1 (n= 47, 134)	25.23 (30.84)	22.89 (25.00)
Dyspnea: C12D1 (n= 37, 132)	26.67 (26.84)	22.73 (25.83)
Dyspnea: C13D1 (n= 30, 123)	19.30 (23.08)	25.47 (26.68)
Dyspnea: C14D1 (n= 19, 119)	20.37 (25.92)	21.85 (25.47)
Dyspnea: C15D1 (n= 16, 113)	16.67 (17.21)	22.71 (24.51)
Dyspnea: C16D1 (n= 13, 109)	20.51 (16.88)	21.71 (25.00)
Dyspnea: C17D1 (n= 11, 98)	15.15 (17.41)	21.43 (23.57)
Dyspnea: C18D1 (n= 10, 92)	20.00 (17.21)	22.83 (25.64)
Dyspnea: C19D1 (n= 9, 84)	11.11 (16.67)	23.41 (23.59)
Dyspnea: C20D1 (n= 9, 80)	18.52 (17.57)	21.67 (24.36)
Dyspnea: C21D1 (n= 9, 75)	18.52 (17.57)	19.11 (20.63)
Dyspnea: C22D1 (n= 8, 68)	20.83 (35.36)	20.59 (23.06)
Dyspnea: C23D1 (n= 8, 65)	12.50 (17.25)	18.46 (21.27)
Dyspnea: C24D1 (n= 5, 64)	6.67 (14.91)	19.79 (24.28)
Dyspnea: C25D1 (n= 3, 60)	11.11 (19.24)	20.00 (22.30)
Dyspnea: C26D1 (n= 3, 55)	0.00 (0.00)	20.00 (24.51)
Dyspnea: C27D1 (n= 3, 52)	0.00 (0.00)	16.03 (19.23)
Dyspnea: C28D1 (n= 1, 49)	0.00 (NA)	17.01 (20.55)
Dyspnea: C29D1 (n= 2, 40)	33.33 (47.14)	15.00 (21.28)
Dyspnea: C30D1 (n= 1, 31)	0.00 (NA)	16.13 (18.99)
Dyspnea: C31D1 (n= 0, 24)	NA (NA)	22.22 (23.40)
Dyspnea: C32D1 (n= 0, 22)	NA (NA)	22.73 (21.54)
Dyspnea: C33D1 (n= 0, 16)	NA (NA)	25.00 (31.03)
Dyspnea: C34D1 (n= 0, 14)	NA (NA)	26.19 (26.73)
Dyspnea: C35D1 (n= 0, 12)	NA (NA)	25.00 (25.13)
Dyspnea: C36D1 (n= 0, 8)	NA (NA)	20.83 (17.25)
Dyspnea: C37D1 (n= 0, 5)	NA (NA)	26.67 (14.91)
Dyspnea: C38D1 (n= 0, 2)	NA (NA)	33.33 (0.00)
Dyspnea: EOT(n= 266, 247)	38.72 (30.51)	39.41 (32.57)
Dyspnea: Pro Week 6 Pd (n= 0, 1)	NA (NA)	33.33 (NA)
Dyspnea: Survival Follow-Up 1 (n= 2, 1)	33.33 (47.14)	33.33 (NA)

18. Secondary Outcome

Title	EORTC QLQ-C30 Questionnaire Score: Functional Subscales
Description	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Cognitive: Baseline (n= 390, 411)	83.38 (20.68)	85.16 (19.16)
Cognitive: C2D1 (n= 341, 363)	83.38 (21.64)	84.94 (19.30)
Cognitive: C3D1(n= 256, 305)	84.05 (19.82)	86.28 (17.32)
Cognitive: C4D1(n= 224, 281)	84.82 (19.27)	85.35 (19.87)
Cognitive: C5D1(n= 166, 238)	86.04 (17.24)	84.38 (19.73)
Cognitive: C6D1(n= 151, 224)	86.09 (18.20)	84.45 (20.27)
Cognitive: C7D1(n= 87, 189)	87.55 (16.32)	84.74 (18.93)
Cognitive: C8D1(n= 72, 171)	89.58 (13.83)	85.58 (18.87)
Cognitive: C9D1(n= 50, 153)	90.00 (14.29)	85.95 (18.65)
Cognitive: C10D1(n= 47, 146)	91.13 (11.96)	86.53 (19.31)
Cognitive: C11D1(n= 36, 134)	92.59 (10.87)	85.95 (19.91)
Cognitive: C12D1(n= 30, 132)	91.11 (12.17)	84.22 (20.52)
Cognitive: C13D1(n= 18, 124)	90.74 (11.75)	84.27 (21.50)
Cognitive: C14D1(n= 17, 121)	92.16 (11.96)	85.67 (18.30)
Cognitive: C15D1(n= 15, 113)	93.33 (10.54)	85.10 (19.08)
Cognitive: C16D1(n= 12, 109)	97.22 (6.49)	85.32 (21.12)
Cognitive: C17D1(n= 11, 98)	96.97 (6.74)	85.37 (20.48)
Cognitive: C18D1(n= 10, 92)	91.67 (11.79)	82.97 (20.52)
Cognitive: C19D1(n= 9, 84)	92.59 (12.11)	83.53 (20.12)
Cognitive: C20D1(n= 9, 80)	90.74 (14.70)	82.29 (22.87)
Cognitive: C21D1(n= 9, 75)	87.04 (23.24)	83.78 (20.32)
Cognitive: C22D1(n= 8, 68)	89.58 (12.40)	84.56 (21.03)
Cognitive: C23D1(n= 8, 66)	95.83 (7.72)	84.09 (20.55)
Cognitive: C24D1(n= 5, 64)	83.33 (23.57)	83.85 (23.56)
Cognitive: C25D1(n= 3, 60)	72.22 (25.46)	83.61 (21.59)
Cognitive: C26D1(n= 3, 55)	77.78 (19.24)	82.73 (21.51)
Cognitive: C27D1(n= 3, 52)	88.89 (19.24)	85.26 (20.25)
Cognitive: C28D1(n= 1, 48)	100.00 (NA)	85.07 (20.98)
Cognitive: C29D1(n= 2, 40)	50.00 (70.71)	83.75 (20.84)
Cognitive: C30D1(n= 1, 31)	100.00 (NA)	86.02 (20.68)
Cognitive: C31D1(n= 0, 24)	NA (NA)	80.56 (21.23)
Cognitive: C32D1(n= 0, 22)	NA (NA)	82.58 (22.11)
Cognitive: C33D1(n= 0,16)	NA (NA)	77.08 (25.73)
Cognitive: C34D1(n= 0, 14)	NA (NA)	80.95 (24.33)
Cognitive: C35D1(n= 0, 12)	NA (NA)	76.39 (21.86)
Cognitive: C36D1(n= 0, 8)	NA (NA)	83.33 (15.43)
Cognitive: C37D1(n= 0, 5)	NA (NA)	83.33 (16.67)
Cognitive: C38D1(n= 0, 2)	NA (NA)	91.67 (11.79)
Cognitive: EOT (n= 266, 246)	78.82 (24.54)	78.52 (22.50)
Cognitive: Pro Week 6 Pd(n= 0,1)	NA (NA)	83.33 (NA)
Cognitive: Survival FU 1 (n= 2, 1)	50.00 (47.14)	0.00 (NA)
Emotional: Baseline (n= 390, 411)	75.83 (22.59)	76.55 (21.77)
Emotional: C2D1(n= 341, 363)	78.06 (22.63)	79.47 (20.72)
Emotional: C3D1(n= 256, 305)	79.70 (22.24)	82.71 (17.45)
Emotional: C4D1(n= 224, 280)	81.67 (20.36)	83.69 (17.70)
Emotional: C5D1(n= 166, 238)	80.52 (20.24)	81.99 (19.22)
Emotional: C6D1(n= 151, 224)	81.73 (20.50)	82.70 (19.91)
Emotional: C7D1(n= 87, 189)	81.42 (22.00)	83.77 (17.71)
Emotional: C8D1(n= 72, 171)	84.38 (18.66)	83.63 (19.40)
Emotional: C9D1(n= 50, 153)	86.00 (17.93)	85.62 (18.72)
Emotional: C10D1(n= 47, 146)	84.93 (17.69)	84.13 (19.74)
Emotional: C11D1(n= 36, 134)	89.12 (15.15)	84.16 (18.14)
Emotional: C12D1(n= 30, 132)	86.94 (14.79)	84.34 (20.10)
Emotional: C13D1(n= 18, 123)	89.35 (14.52)	84.35 (19.75)
Emotional: C14D1(n= 17, 121)	86.27 (15.57)	84.25 (19.11)
Emotional: C15D1(n= 15, 113)	90.00 (14.16)	83.87 (20.04)
Emotional: C16D1(n= 12, 109)	88.89 (16.02)	82.11 (22.59)
Emotional: C17D1(n= 11, 98)	88.64 (17.59)	83.25 (19.50)
Emotional: C18D1(n= 10, 92)	87.50 (19.35)	82.52 (21.11)
Emotional: C19D1(n= 9, 84)	87.96 (19.14)	81.42 (20.55)
Emotional: C20D1(n=9, 80)	76.85 (34.30)	83.19 (18.90)
Emotional: C21D1(n= 9, 75)	83.33 (26.68)	84.19 (17.58)
Emotional: C22D1(n= 8, 68)	76.74 (32.60)	86.03 (16.44)
Emotional: C23D1(n= 8, 66)	89.58 (15.91)	87.00 (17.55)
Emotional: C24D1(n=5, 65)	78.33 (33.12)	83.72 (19.18)
Emotional: C25D1(n= 3, 60)	100.00 (0.00)	83.66 (18.77)
Emotional: C26D1(n= 3, 55)	86.11 (12.73)	85.15 (19.69)
Emotional: C27D1(n= 3, 52)	100.00 (0.00)	86.38 (18.38)
Emotional: C28D1(n= 1, 48)	100.00 (NA)	86.92 (17.51)
Emotional: C29D1(n= 2, 40)	50.00 (70.71)	87.50 (16.45)
Emotional: C30D1(n= 1, 31)	100.00 (NA)	89.79 (15.62)
Emotional: C31D1(n= 0, 24)	NA (NA)	85.76 (18.30)
Emotional: C32D1(n= 0, 22)	NA (NA)	82.95 (20.81)
Emotional: C33D1(n= 0, 16)	NA (NA)	81.25 (25.37)
Emotional: C34D1(n= 0, 14)	NA (NA)	82.14 (25.29)
Emotional: C35D1(n= 0, 12)	NA (NA)	83.33 (21.61)
Emotional: C36D1(n= 0, 8)	NA (NA)	95.83 (11.78)
Emotional: C37D1(n= 0, 5)	NA (NA)	90.00 (14.91)
Emotional: C38D1(n= 0, 2)	NA (NA)	83.33 (23.57)
Emotional: EOT (n= 265, 246)	73.78 (26.29)	73.92 (23.74)
Emotional: Pro Week 6 Pd(n= 0,1)	NA (NA)	66.67 (NA)
Emotional: Survival FU-1 (n= 2,1)	25.00 (35.36)	33.33 (NA)
Physical: Baseline (n= 390, 413)	73.27 (22.58)	74.46 (20.66)
Physical: C2D1(n= 343, 369)	72.64 (22.00)	71.70 (22.49)
Physical: C3D1(n= 255, 304)	74.98 (21.60)	76.19 (19.48)
Physical: C4D1(n= 224, 277)	75.72 (19.05)	76.79 (19.95)
Physical: C5D1(n= 167, 238)	77.30 (19.00)	77.79 (19.89)
Physical: C6D1(n= 151, 225)	74.77 (19.26)	78.93 (18.76)
Physical: C7D1(n= 88, 189)	77.61 (18.08)	79.20 (18.42)
Physical: C8D1(n= 71, 170)	78.45 (17.72)	78.87 (18.91)
Physical: C9D1(n= 50, 153)	79.07 (20.43)	79.46 (18.75)
Physical: C10D1(n= 47, 146)	79.29 (19.96)	79.41 (18.85)
Physical: C11D1(n= 37, 134)	81.44 (20.85)	79.09 (20.50)
Physical: C12D1(n= 30, 132)	82.22 (15.69)	79.72 (18.84)
Physical: C13D1(n= 19, 124)	87.37 (9.66)	80.48 (19.33)
Physical: C14D1(n= 18, 121)	85.56 (9.50)	80.33 (17.55)
Physical: C15D1(n= 16, 113)	86.25 (8.24)	79.88 (18.64)
Physical: C16D1(n= 13, 109)	85.13 (9.49)	78.82 (21.32)
Physical: C17D1(n= 11, 98)	84.24 (12.03)	78.57 (20.89)
Physical: C18D1(n= 10, 92)	82.67 (13.03)	79.64 (19.92)
Physical: C19D1(n= 9, 84)	87.41 (10.77)	78.97 (20.48)
Physical: C20D1(n= 9, 80)	81.48 (18.19)	79.19 (20.26)
Physical: C21D1(n= 9, 75)	87.41 (11.28)	78.67 (20.68)
Physical: C22D1(n= 8, 69)	82.50 (19.82)	82.51 (16.92)
Physical: C23D1(n= 8, 66)	85.00 (13.21)	80.81 (17.56)
Physical: C24D1(n= 5, 64)	80.00 (18.26)	81.41 (17.69)
Physical: C25D1(n= 3, 60)	82.22 (16.78)	83.22 (16.67)
Physical: C26D1(n= 3, 55)	75.56 (3.85)	80.12 (17.43)
Physical: C27D1(n= 2, 52)	76.67 (4.71)	81.89 (16.90)
Physical: C28D1(n= 2, 49)	65.00 (21.21)	84.15 (14.41)
Physical: C29D1(n= 2, 40)	56.67 (33.00)	83.00 (14.87)
Physical: C30D1(n= 1, 31)	80.00 (NA)	83.01 (15.67)
Physical: C31D1(n= 0, 24)	NA (NA)	78.61 (17.25)
Physical: C32D1(n= 0, 22)	NA (NA)	75.15 (18.42)
Physical: C33D1(n= 0, 16)	NA (NA)	77.92 (17.84)
Physical: C34D1(n= 0, 14)	NA (NA)	75.24 (19.47)
Physical: C35D1(n= 0, 12)	NA (NA)	73.89 (20.78)
Physical: C36D1(n= 0, 8)	NA (NA)	83.33 (17.46)
Physical: C37D1(n= 0, 5)	NA (NA)	74.67 (14.45)
Physical: C38D1(n= 0, 2)	NA (NA)	86.67 (0.00)
Physical: EOT(n= 267, 246)	63.59 (24.57)	64.78 (26.47)
Physical: Pro Week 6 Pd(n= 0, 1)	NA (NA)	46.67 (NA)
Physical: Survival FU-1 (n= 2, 1)	36.67 (51.85)	46.67 (NA)
Role: Baseline (n=388, 413)	70.92 (30.68)	73.61 (29.13)
Role: C2D1 (n=339, 369)	69.91 (29.89)	68.29 (31.50)
Role: C3D1 (n=256, 304)	74.61 (27.21)	75.27 (27.28)
Role: C4D1 (n=224, 279)	73.36 (26.22)	76.70 (25.27)
Role: C5D1 (n=167, 238)	74.35 (25.00)	76.05 (26.97)
Role: C6D1 (n=151, 225)	73.62 (26.62)	77.70 (26.78)
Role: C7D1 (n=88, 190)	77.27 (23.19)	79.04 (24.97)
Role: C8D1 (n=72, 170)	73.61 (26.50)	77.35 (25.22)
Role: C9D1 (n=50, 153)	77.67 (24.42)	79.30 (25.36)
Role: C10D1 (n=47, 145)	78.72 (27.74)	81.38 (24.34)
Role: C11D1 (n=37, 134)	80.63 (24.69)	78.61 (27.01)
Role: C12D1 (n=30, 132)	81.11 (22.20)	79.80 (25.97)
Role: C13D1 (n=19, 124)	84.21 (18.82)	79.44 (26.55)
Role: C14D1 (n=18, 121)	78.70 (21.24)	79.48 (24.98)
Role: C15D1 (n=16, 113)	83.33 (14.91)	79.20 (25.05)
Role: C16D1 (n=13, 109)	85.90 (19.06)	76.45 (27.89)
Role: C17D1 (n=11, 98)	80.30 (20.84)	76.02 (29.22)
Role: C18D1 (n=10, 92)	80.00 (26.99)	77.17 (27.59)
Role: C19D1 (n=9, 84)	85.19 (22.74)	78.17 (28.46)
Role: C20D1 (n=9, 80)	79.63 (29.79)	78.54 (26.01)
Role: C21D1 (n=9, 75)	85.19 (15.47)	77.33 (28.29)
Role: C22D1 (n=8, 69)	79.17 (35.36)	81.64 (26.68)
Role: C23D1 (n=8, 66)	85.42 (20.77)	80.30 (26.13)
Role: C24D1 (n=5, 65)	70.00 (34.16)	78.72 (26.92)
Role: C25D1 (n=3, 60)	77.78 (38.49)	79.44 (27.34)
Role: C26D1 (n=3, 55)	83.33 (28.87)	76.97 (27.31)
Role: C27D1 (n=3, 52)	88.89 (19.24)	80.77 (26.89)
Role: C28D1 (n=1, 49)	100.00 (NA)	82.99 (22.69)
Role: C29D1 (n=2, 40)	66.67 (47.14)	83.33 (24.75)
Role: C30D1 (n=1, 31)	100.00 (NA)	81.72 (24.10)
Role: C31D1(n=0, 24)	NA (NA)	79.86 (25.53)
Role: C32D1(n=0, 22)	NA (NA)	75.00 (27.58)
Role: C33D1(n=0, 16)	NA (NA)	66.67 (34.43)
Role: C34D1(n=0, 14)	NA (NA)	69.05 (33.88)
Role: C35D1(n=0, 12)	NA (NA)	69.44 (32.44)
Role: C36D1(n=0, 8)	NA (NA)	87.50 (17.25)
Role: C37D1(n=0, 5)	NA (NA)	76.67 (22.36)
Role: C38D1(n=0, 2)	NA (NA)	100.00 (0.00)
Role: EOT(n=266, 246)	58.52 (32.99)	60.03 (33.25)
Role: Pro Week 6 Pd (n=0, 1)	NA (NA)	66.67 (NA)
Role: Survival FU-1 (n=2,1)	33.33 (47.14)	33.33 (NA)
Social: Baseline (n= 389, 411)	74.16 (26.92)	77.41 (26.13)
Social: C2D1(n= 340, 363)	74.51 (26.50)	76.86 (26.25)
Social: C3D1(n= 255, 305)	78.37 (25.30)	81.15 (23.70)
Social: C4D1(n= 223, 280)	79.60 (23.00)	81.31 (24.15)
Social: C5D1(n= 166, 238)	79.32 (22.26)	82.00 (24.39)
Social: C6D1(n= 151, 224)	78.15 (24.05)	81.99 (23.80)
Social: C7D1(n= 87, 189)	80.65 (22.57)	82.80 (22.54)
Social: C8D1(n= 72, 171)	81.94 (22.16)	81.19 (23.95)
Social: C9D1(n= 50, 153)	82.00 (22.80)	83.77 (22.29)
Social: C10D1(n= 47, 146)	81.21 (24.97)	83.79 (22.99)
Social: C11D1(n= 36, 134)	82.41 (26.11)	81.47 (25.42)
Social: C12D1(n= 30, 132)	86.67 (18.77)	82.95 (24.58)
Social: C13D1(n= 18, 124)	89.81 (15.27)	84.27 (22.82)
Social: C14D1(n= 17, 121)	86.27 (19.75)	84.16 (22.55)
Social: C15D1(n= 15, 113)	93.33 (13.80)	83.92 (22.26)
Social: C16D1(n= 12, 109)	84.72 (16.60)	82.72 (24.73)
Social: C17D1(n= 11, 98)	87.88 (16.82)	82.99 (23.57)
Social: C18D1(n= 10, 92)	86.67 (17.21)	81.34 (24.06)
Social: C19D1(n= 9, 84)	88.89 (16.67)	81.94 (25.90)
Social: C20D1(n= 9, 80)	81.48 (33.79)	81.46 (24.73)
Social: C21D1(n= 9, 75)	85.19 (24.22)	78.67 (27.88)
Social: C22D1(n= 8, 68)	85.42 (30.13)	84.31 (25.41)
Social: C23D1(n= 8, 66)	91.67 (15.43)	80.56 (26.24)
Social: C24D1(n= 5, 65)	80.00 (27.39)	80.77 (25.38)
Social: C25D1(n= 3, 60)	77.78 (38.49)	81.39 (27.80)
Social: C26D1(n= 3, 55)	77.78 (19.24)	79.70 (27.53)
Social: C27D1(n= 3, 52)	88.89 (19.24)	82.05 (25.32)
Social: C28D1(n= 1, 48)	100.00 (NA)	84.03 (24.30)
Social: C29D1(n= 2, 40)	50.00 (70.71)	82.92 (24.60)
Social: C30D1(n= 1, 31)	100.00 (NA)	79.57 (27.79)
Social: C31D1(n= 0, 24)	NA (NA)	79.17 (26.12)
Social: C32D1(n= 0, 22)	NA (NA)	73.48 (30.71)
Social: C33D1(n= 0, 16)	NA (NA)	73.96 (32.19)
Social: C34D1(n= 0, 14)	NA (NA)	67.86 (34.88)
Social: C35D1(n= 0, 12)	NA (NA)	70.83 (31.88)
Social: C36D1(n= 0, 8)	NA (NA)	87.50 (17.25)
Social: C37D1(n= 0, 5)	NA (NA)	80.00 (18.26)
Social: C38D1(n= 0, 2)	NA (NA)	100.00 (0.00)
Social: EOT(n= 264, 245)	69.51 (30.65)	70.00 (30.05)
Social: Pro Week 6 Pd(n= 0, 1)	NA (NA)	66.67 (NA)
Social: Survival FU-1 (n= 2, 1)	83.33 (23.57)	16.67 (NA)

19. Secondary Outcome

Title	EORTC QLQ-C30 Questionnaire Score: GHS Scale
Description	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Global Health: Baseline (n= 387, 410)	60.55 (22.25)	61.24 (22.31)
Global Health: C2D1(n= 339, 361)	59.56 (22.15)	58.93 (23.57)
Global Health: C3D1(n= 255, 304)	64.64 (18.66)	64.61 (20.74)
Global Health: C4D1(n= 222, 279)	63.51 (20.67)	65.11 (21.36)
Global Health: C5D1(n= 166, 235)	64.01 (18.37)	66.35 (19.84)
Global Health: C6D1(n= 151, 223)	64.51 (19.59)	65.73 (21.42)
Global Health: C7D1(n= 87, 187)	64.85 (18.13)	66.93 (19.61)
Global Health: C8D1(n= 72, 169)	62.73 (20.22)	67.36 (19.45)
Global Health: C9D1(n= 50, 152)	67.17 (18.93)	68.09 (19.46)
Global Health: C10D1(n= 47, 145)	66.84 (18.67)	69.37 (20.90)
Global Health: C11D1(n= 36, 133)	69.68 (17.15)	68.17 (21.24)
Global Health: C12D1(n= 30, 131)	66.67 (18.05)	68.32 (20.42)
Global Health: C13D1(n= 18, 124)	69.91 (14.33)	67.74 (22.52)
Global Health: C14D1(n= 17, 120)	69.61 (14.71)	67.01 (20.62)
Global Health: C15D1(n= 15, 113)	69.44 (17.16)	68.66 (20.21)
Global Health: C16D1(n= 12, 109)	62.50 (15.69)	67.97 (21.67)
Global Health: C17D1(n= 10, 98)	61.67 (19.72)	68.62 (19.84)
Global Health: C18D1(n= 10, 92)	61.67 (21.23)	68.57 (18.86)
Global Health: C19D1(n= 9, 84)	65.74 (21.43)	68.25 (20.10)
Global Health: C20D1(n= 9, 80)	62.04 (26.72)	68.12 (20.10)
Global Health: C21D1(n= 9, 75)	60.19 (29.98)	66.56 (21.55)
Global Health: C22D1(n= 8, 68)	54.17 (24.80)	73.28 (17.13)
Global Health: C23D1(n= 8, 66)	62.50 (19.42)	70.45 (18.09)
Global Health: C24D1(n= 5, 65)	70.00 (27.39)	69.36 (19.27)
Global Health: C25D1(n= 3, 60)	66.67 (28.87)	69.03 (19.23)
Global Health: C26D1(n= 3, 55)	66.67 (28.87)	68.64 (20.60)
Global Health: C27D1(n= 3, 52)	66.67 (28.87)	68.91 (21.84)
Global Health: C28D1(n= 2, 48)	87.50 (17.68)	71.87 (20.60)
Global Health: C29D1(n= 2, 40)	91.67 (11.79)	72.71 (20.06)
Global Health: C30D1(n= 1, 30)	83.33 (NA)	75.28 (18.63)
Global Health: C31D1(n= 0, 24)	NA (NA)	71.53 (21.13)
Global Health: C32D1(n= 0, 22)	NA (NA)	70.45 (20.21)
Global Health: C33D1(n= 0,16)	NA (NA)	67.19 (27.30)
Global Health: C34D1(n= 0, 14)	NA (NA)	68.45 (26.19)
Global Health: C35D1(n= 0, 12)	NA (NA)	69.44 (26.43)
Global Health: C36D1(n= 0, 8)	NA (NA)	80.21 (16.63)
Global Health: C37D1(n= 0, 5)	NA (NA)	76.67 (19.00)
Global Health: C38D1(n= 0, 2)	NA (NA)	91.67 (11.79)
Global Health: EOT(n= 262, 245)	51.69 (24.02)	52.82 (24.48)
Global Health: Pro Week 6 Pd(n= 0,1)	NA (NA)	50.00 (NA)
Global Health: Survival FU 1 (n= 2, 1)	58.33 (35.36)	33.33 (NA)

20. Secondary Outcome

Title	EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
Description	EORTC QLQ-C30 included GHS/QOL, functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 were a 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale and were a 7-point scale (1/Very Poor to 7/Excellent). For this instrument, GHS/QOL and functional scales were linearly transformed so each score ranged 0-100, where lower scores indicate poorer functioning (e.g., worsening) and higher scores indicate better functioning (e.g., improvement). Symptom scales/items were also linearly transformed so each score ranged 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Nausea/Vomiting: Baseline (n= 389, 413)	8.01 (16.34)	7.59 (16.35)
Nausea/Vomiting: C2D1(n= 342, 369)	11.50 (19.30)	9.53 (17.25)
Nausea/Vomiting: C3D1(n= 253, 305)	7.05 (15.06)	7.27 (15.32)
Nausea/Vomiting: C4D1(n= 223, 279)	7.40 (14.37)	7.17 (15.50)
Nausea/Vomiting: C5D1(n= 167, 238)	6.29 (12.49)	6.44 (14.54)
Nausea/Vomiting: C6D1(n= 151, 225)	6.40 (13.17)	6.44 (15.16)
Nausea/Vomiting: C7D1(n= 88, 190)	6.82 (13.28)	5.61 (13.74)
Nausea/Vomiting: C8D1(n= 72, 170)	6.02 (12.91)	4.61 (10.57)
Nausea/Vomiting: C9D1(n= 50, 153)	3.33 (8.91)	2.83 (8.06)
Nausea/Vomiting: C10D1(n= 47, 146)	2.48 (6.93)	3.54 (10.02)
Nausea/Vomiting: C11D1(n= 37, 134)	3.15 (6.62)	3.23 (8.54)
Nausea/Vomiting: C12D1(n= 30, 132)	3.89 (8.40)	3.03 (7.66)
Nausea/Vomiting: C13D1(n= 19, 124)	4.39 (9.37)	3.36 (10.19)
Nausea/Vomiting: C14D1(n= 18, 121)	4.63 (9.58)	3.31 (9.03)
Nausea/Vomiting: C15D1(n= 16, 113)	1.04 (4.17)	3.83 (11.14)
Nausea/Vomiting: C16D1(n= 13, 109)	5.13 (10.51)	2.75 (8.64)
Nausea/Vomiting: C17D1(n= 11, 98)	9.09 (13.67)	2.55 (8.06)
Nausea/Vomiting: C18D1(n= 10, 92)	6.67 (11.65)	3.08 (8.88)
Nausea/Vomiting: C19D1(n= 9, 84)	3.70 (7.35)	4.17 (11.53)
Nausea/Vomiting: C20D1(n= 9, 80)	5.56 (8.33)	3.13 (11.28)
Nausea/Vomiting: C21D1(n= 9, 75)	1.85 (5.56)	4.89 (13.08)
Nausea/Vomiting: C22D1(n= 8, 69)	6.25 (8.63)	1.93 (7.31)
Nausea/Vomiting: C23D1(n= 8, 66)	6.25 (12.40)	2.53 (6.69)
Nausea/Vomiting: C24D1(n= 5, 64)	0.00 (0.00)	2.34 (7.19)
Nausea/Vomiting: C25D1(n= 3, 60)	0.00 (0.00)	1.94 (6.21)
Nausea/Vomiting: C26D1(n= 3, 55)	0.00 (0.00)	2.73 (8.34)
Nausea/Vomiting: C27D1(n= 3, 52)	0.00 (0.00)	2.24 (6.62)
Nausea/Vomiting: C28D1(n= 1, 49)	0.00 (NA)	1.02 (4.04)
Nausea/Vomiting: C29D1(n= 2, 40)	33.33 (47.14)	1.67 (5.06)
Nausea/Vomiting: C30D1(n= 1, 31)	0.00 (NA)	1.61 (5.01)
Nausea/Vomiting: C31D1(n= 0, 24)	NA (NA)	2.08 (5.63)
Nausea/Vomiting: C32D1(n= 0, 22)	NA (NA)	1.52 (4.90)
Nausea/Vomiting: C33D1(n= 0,16)	NA (NA)	1.04 (4.17)
Nausea/Vomiting: C34D1(n= 0, 14)	NA (NA)	2.38 (8.91)
Nausea/Vomiting: C35D1(n= 0, 12)	NA (NA)	1.39 (4.81)
Nausea/Vomiting: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Nausea/Vomiting: C37D1(n= 0, 5)	NA (NA)	6.67 (9.13)
Nausea/Vomiting: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Nausea/Vomiting: EOT(n= 266, 245)	11.65 (20.11)	10.61 (17.62)
Nausea/Vomiting: Pro Week 6 Pd(n= 0,1)	NA (NA)	16.67 (NA)
Nausea/Vomiting: Survival FU 1 (n= 2, 1)	50.00 (70.71)	66.67 (NA)
Pain: Baseline (n= 390, 413)	29.70 (29.45)	29.98 (29.72)
Pain: C2D1(n= 343, 368)	28.43 (27.24)	29.30 (29.03)
Pain: C3D1(n= 256, 305)	22.59 (24.93)	24.15 (27.50)
Pain: C4D1(n= 224, 280)	21.65 (24.48)	23.75 (25.84)
Pain: C5D1(n= 167, 239)	20.96 (22.55)	23.22 (25.41)
Pain: C6D1(n= 151, 225)	22.41 (21.95)	21.63 (24.68)
Pain: C7D1(n= 88, 190)	21.59 (22.34)	21.58 (25.30)
Pain: C8D1(n= 72, 171)	23.38 (22.49)	22.03 (24.36)
Pain: C9D1(n= 50, 153)	16.33 (20.89)	19.28 (23.50)
Pain: C10D1(n= 47, 146)	14.54 (17.93)	21.00 (24.61)
Pain: C11D1(n= 37, 134)	13.96 (22.05)	21.27 (26.60)
Pain: C12D1(n= 30, 132)	13.33 (21.17)	18.69 (24.71)
Pain: C13D1(n= 19, 124)	16.67 (25.46)	17.74 (21.23)
Pain: C14D1(n= 18, 120)	12.04 (15.97)	17.64 (22.17)
Pain: C15D1(n= 16, 113)	10.42 (17.08)	17.40 (22.86)
Pain: C16D1(n= 13, 109)	21.79 (21.93)	20.64 (25.25)
Pain: C17D1(n= 11, 98)	16.67 (19.72)	20.41 (25.39)
Pain: C18D1(n= 10, 92)	11.67 (22.29)	20.83 (24.54)
Pain: C19D1(n= 9, 84)	14.81 (22.74)	22.42 (28.16)
Pain: C20D1(n=9, 80)	27.78 (31.18)	20.00 (23.78)
Pain: C21D1(n= 9, 75)	14.81 (17.57)	19.78 (25.95)
Pain: C22D1(n= 8, 69)	18.75 (20.77)	15.22 (19.75)
Pain: C23D1(n= 8, 66)	14.58 (27.37)	16.92 (23.11)
Pain: C24D1(n=5, 64)	30.00 (36.13)	20.05 (25.05)
Pain: C25D1(n= 3, 60)	16.67 (28.87)	18.33 (22.90)
Pain: C26D1(n= 3, 55)	22.22 (19.24)	16.36 (21.87)
Pain: C27D1(n= 3, 52)	11.11 (19.24)	15.06 (20.41)
Pain: C28D1(n= 1, 49)	0.00 (NA)	14.29 (18.63)
Pain: C29D1(n= 2, 40)	41.67 (58.93)	13.75 (18.06)
Pain: C30D1(n= 1, 31)	0.00 (NA)	15.05 (21.24)
Pain: C31D1(n= 0, 24)	NA (NA)	14.58 (21.03)
Pain: C32D1(n= 0, 22)	NA (NA)	16.67 (24.67)
Pain: C33D1(n= 0, 16)	NA (NA)	20.83 (27.55)
Pain: C34D1(n= 0, 14)	NA (NA)	26.19 (27.51)
Pain: C35D1(n= 0, 12)	NA (NA)	22.22 (25.95)
Pain: C36D1(n= 0, 8)	NA (NA)	22.92 (34.43)
Pain: C37D1(n= 0, 5)	NA (NA)	30.00 (34.16)
Pain: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Pain: EOT (n= 267, 247)	32.21 (30.36)	35.43 (31.22)
Pain: Pro Week 6 Pd(n= 0,1)	NA (NA)	16.67 (NA)
Pain: Survival FU-1 (n= 2,1)	66.67 (47.14)	83.33 (NA)
Fatigue: Baseline (n= 390, 413)	37.59 (25.69)	36.21 (23.92)
Fatigue: C2D1(n= 343, 369)	40.52 (25.68)	39.78 (26.17)
Fatigue: C3D1(n= 256, 304)	35.29 (23.97)	33.90 (23.75)
Fatigue: C4D1(n= 224, 278)	35.59 (23.10)	30.72 (22.57)
Fatigue: C5D1(n= 167, 238)	36.03 (22.40)	30.95 (24.13)
Fatigue: C6D1(n= 151, 225)	36.28 (23.40)	28.89 (22.66)
Fatigue: C7D1(n= 88, 190)	34.34 (23.02)	28.33 (22.15)
Fatigue: C8D1(n= 72, 170)	30.86 (24.12)	27.97 (21.56)
Fatigue: C9D1(n= 50, 153)	28.67 (23.45)	25.78 (21.39)
Fatigue: C10D1(n= 47, 145)	29.31 (25.21)	26.32 (22.27)
Fatigue: C11D1(n= 37, 134)	27.63 (25.07)	25.62 (23.05)
Fatigue: C12D1(n= 30, 132)	28.89 (23.99)	26.60 (23.37)
Fatigue: C13D1(n= 19, 124)	22.22 (20.29)	27.51 (22.73)
Fatigue: C14D1(n= 18, 121)	21.60 (16.82)	26.31 (23.13)
Fatigue: C15D1(n= 16, 112)	20.14 (18.24)	27.73 (22.56)
Fatigue: C16D1(n= 13, 109)	21.79 (17.64)	27.22 (23.35)
Fatigue: C17D1(n= 11, 98)	22.22 (12.17)	27.21 (23.56)
Fatigue: C18D1(n= 10, 92)	26.67 (17.53)	27.29 (24.18)
Fatigue: C19D1(n= 9, 84)	22.22 (14.70)	27.65 (22.85)
Fatigue: C20D1(n= 9, 80)	32.10 (30.15)	25.21 (23.47)
Fatigue: C21D1(n= 9, 75)	28.39 (18.52)	26.44 (23.66)
Fatigue: C22D1(n= 8, 69)	33.33 (29.10)	22.38 (21.77)
Fatigue: C23D1(n= 8, 66)	25.00 (24.31)	24.16 (20.59)
Fatigue: C24D1(n= 5, 64)	31.11 (40.37)	23.78 (18.87)
Fatigue: C25D1(n= 3, 60)	11.11 (19.24)	23.89 (20.94)
Fatigue: C26D1(n= 3, 55)	18.52 (16.97)	28.69 (24.54)
Fatigue: C27D1(n= 3, 52)	11.11 (19.24)	22.65 (19.80)
Fatigue: C28D1(n= 1, 49)	0.00 (NA)	22.34 (18.23)
Fatigue: C29D1(n= 2, 40)	44.44 (47.14)	21.11 (18.63)
Fatigue: C30D1(n= 1, 31)	22.22 (NA)	23.66 (20.23)
Fatigue: C31D1(n= 0, 24)	NA (NA)	23.15 (20.96)
Fatigue: C32D1(n= 0, 22)	NA (NA)	25.25 (20.63)
Fatigue: C33D1(n= 0, 16)	NA (NA)	29.86 (26.52)
Fatigue: C34D1(n= 0, 14)	NA (NA)	31.75 (24.21)
Fatigue: C35D1(n= 0, 12)	NA (NA)	25.00 (21.25)
Fatigue: C36D1(n= 0, 8)	NA (NA)	16.67 (15.71)
Fatigue: C37D1(n= 0, 5)	NA (NA)	24.44 (16.48)
Fatigue: C38D1(n= 0, 2)	NA (NA)	16.67 (7.86)
Fatigue: EOT(n= 267, 246)	47.50 (26.72)	43.07 (28.15)
Fatigue: Pro Week 6 Pd(n= 0, 1)	NA (NA)	44.44 (NA)
Fatigue: Survival FU-1 (n= 2, 1)	83.33 (23.57)	88.89 (NA)

21. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Alopecia
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for alopecia.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Alopecia: Baseline (n= 384, 405)	13.89 (27.95)	14.32 (29.07)
Alopecia: C2D1(n= 332, 357)	60.44 (36.66)	6.63 (16.84)
Alopecia: C3D1(n= 248, 300)	56.72 (35.86)	7.44 (18.89)
Alopecia: C4D1(n= 219, 270)	52.36 (35.24)	7.41 (19.14)
Alopecia: C5D1(n= 163, 234)	56.65 (37.25)	6.41 (16.68)
Alopecia: C6D1(n= 147, 220)	54.42 (37.64)	7.88 (19.34)
Alopecia: C7D1(n= 87, 186)	52.11 (39.28)	5.91 (16.10)
Alopecia: C8D1(n= 70, 166)	48.57 (37.94)	6.63 (17.68)
Alopecia: C9D1(n= 47, 150)	48.23 (39.81)	5.11 (14.83)
Alopecia: C10D1(n= 45, 142)	49.63 (39.96)	3.76 (13.23)
Alopecia: C11D1(n= 36, 130)	47.22 (45.34)	3.08 (11.33)
Alopecia: C12D1(n= 29, 129)	36.78 (43.04)	4.91 (13.88)
Alopecia: C13D1(n= 19, 121)	42.11 (41.34)	6.06 (15.52)
Alopecia: C14D1(n= 18, 119)	29.63 (35.95)	5.60 (14.60)
Alopecia: C15D1(n= 16, 110)	33.33 (34.43)	7.27 (17.12)
Alopecia: C16D1(n= 12, 105)	27.78 (31.25)	7.30 (17.89)
Alopecia: C17D1(n= 11, 95)	21.21 (30.81)	9.47 (19.85)
Alopecia: C18D1(n= 9, 90)	22.22 (33.33)	8.89 (17.16)
Alopecia: C19D1(n= 8, 81)	25.00 (34.50)	10.29 (18.74)
Alopecia: C20D1(n= 9, 78)	44.44 (44.10)	8.55 (15.60)
Alopecia: C21D1(n= 9, 73)	22.22 (33.33)	9.59 (16.18)
Alopecia: C22D1(n= 7, 67)	9.52 (16.26)	9.45 (16.21)
Alopecia: C23D1(n= 8, 64)	29.17 (37.53)	11.46 (18.99)
Alopecia: C24D1(n= 5, 62)	13.33 (18.26)	8.06 (15.61)
Alopecia: C25D1(n= 2, 58)	0.00 (0.00)	9.77 (16.53)
Alopecia: C26D1(n= 2, 53)	0.00 (0.00)	9.43 (16.51)
Alopecia: C27D1(n= 3, 50)	33.33 (57.74)	9.33 (16.55)
Alopecia: C28D1(n= 2, 46)	0.00 (0.00)	6.52 (15.10)
Alopecia: C29D1(n= 2, 38)	0.00 (0.00)	8.77 (20.04)
Alopecia: C30D1(n= 1, 31)	0.00 (NA)	10.75 (19.98)
Alopecia: C31D1(n= 0, 24)	NA (NA)	9.72 (20.80)
Alopecia: C32D1(n= 0, 23)	NA (NA)	7.25 (19.99)
Alopecia: C33D1(n= 0,16)	NA (NA)	8.33 (22.77)
Alopecia: C34D1(n= 0, 14)	NA (NA)	9.52 (20.38)
Alopecia: C35D1(n= 0, 11)	NA (NA)	6.06 (13.48)
Alopecia: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Alopecia: C37D1(n= 0, 5)	NA (NA)	6.67 (14.91)
Alopecia: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Alopecia: EOT(n= 261, 243)	53.51 (38.91)	6.58 (17.48)
Alopecia: Pro Week 6 Pd(n= 0,1)	NA (NA)	100.00 (NA)
Alopecia: Survival FU 1 (n= 2, 1)	100.00 (0.00)	66.67 (NA)

22. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Coughing
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for coughing.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Coughing: Baseline (n= 383, 406)	38.73 (29.64)	37.27 (27.23)
Coughing: C2D1(n= 333, 360)	36.54 (28.04)	37.50 (28.33)
Coughing: C3D1(n= 250, 298)	33.73 (27.46)	33.89 (24.99)
Coughing: C4D1(n= 219, 272)	31.35 (24.13)	32.48 (25.52)
Coughing: C5D1(n= 164, 235)	32.72 (23.49)	31.35 (25.52)
Coughing: C6D1(n= 147, 219)	31.75 (24.78)	31.05 (24.73)
Coughing: C7D1(n= 87, 185)	32.95 (24.64)	30.99 (25.07)
Coughing: C8D1(n= 69, 166)	30.43 (28.43)	29.12 (25.73)
Coughing: C9D1(n= 50, 150)	24.67 (17.57)	29.11 (24.52)
Coughing: C10D1(n= 47, 140)	23.40 (19.55)	27.86 (22.83)
Coughing: C11D1(n= 37, 129)	21.62 (19.59)	27.39 (23.37)
Coughing: C12D1(n= 30, 129)	20.00 (18.77)	25.06 (23.95)
Coughing: C13D1(n= 19, 121)	15.79 (17.10)	24.79 (23.78)
Coughing: C14D1(n= 18, 119)	16.67 (17.15)	24.37 (22.42)
Coughing: C15D1(n= 16, 110)	12.50 (16.67)	25.76 (23.31)
Coughing: C16D1(n= 13, 106)	20.51 (21.68)	24.53 (22.21)
Coughing: C17D1(n= 11, 94)	21.21 (16.82)	24.82 (23.92)
Coughing: C18D1(n= 10, 90)	26.67 (21.08)	26.30 (24.22)
Coughing: C19D1(n= 9, 82)	22.22 (16.67)	25.61 (26.86)
Coughing: C20D1(n= 9, 78)	25.93 (14.70)	28.21 (26.36)
Coughing: C21D1(n= 9, 73)	22.22 (16.67)	28.77 (27.95)
Coughing: C22D1(n= 8, 67)	25.00 (38.83)	22.89 (23.36)
Coughing: C23D1(n= 8, 64)	20.83 (17.25)	23.44 (26.35)
Coughing: C24D1(n= 5, 62)	26.67 (14.91)	24.73 (23.33)
Coughing: C25D1(n= 3, 58)	33.33 (0.00)	25.86 (23.40)
Coughing: C26D1(n= 3, 53)	44.44 (19.25)	26.41 (24.77)
Coughing: C27D1(n= 3, 50)	11.11 (19.24)	24.67 (22.14)
Coughing: C28D1(n= 2, 46)	16.67 (23.57)	20.29 (20.46)
Coughing: C29D1(n= 2, 38)	16.67 (23.57)	19.30 (22.77)
Coughing: C30D1(n= 1, 31)	0.00 (NA)	18.28 (20.80)
Coughing: C31D1(n= 0, 24)	NA (NA)	23.61 (25.02)
Coughing: C32D1(n= 0, 23)	NA (NA)	26.09 (19.99)
Coughing: C33D1(n= 0,16)	NA (NA)	27.08 (32.70)
Coughing: C34D1(n= 0, 14)	NA (NA)	26.19 (29.75)
Coughing: C35D1(n= 0, 11)	NA (NA)	21.21 (22.47)
Coughing: C36D1(n= 0, 8)	NA (NA)	25.00 (15.43)
Coughing: C37D1(n= 0, 5)	NA (NA)	26.67 (14.91)
Coughing: C38D1(n= 0, 2)	NA (NA)	33.33 (0.00)
Coughing: EOT(n= 262, 246)	35.75 (27.03)	38.48 (26.95)
Coughing: Pro Week 6 Pd(n= 0,1)	NA (NA)	33.33 (NA)
Coughing: Survival FU 1 (n= 2, 1)	50.00 (23.57)	33.33 (NA)

23. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Dysphagia
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dysphagia.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Dysphagia: Baseline (n= 387, 406)	6.20 (17.52)	5.09 (15.05)
Dysphagia: C2D1(n= 336, 358)	10.22 (21.50)	6.42 (15.75)
Dysphagia: C3D1(n= 251, 301)	9.16 (20.87)	5.43 (14.53)
Dysphagia: C4D1(n= 217, 272)	8.60 (19.45)	5.88 (16.39)
Dysphagia: C5D1(n= 163, 236)	6.75 (16.63)	6.64 (16.79)
Dysphagia: C6D1(n= 147, 219)	6.80 (15.58)	4.72 (13.28)
Dysphagia: C7D1(n= 87, 187)	4.21 (11.14)	5.70 (15.17)
Dysphagia: C8D1(n=70, 167)	5.71 (12.65)	4.79 (12.82)
Dysphagia: C9D1(n= 50, 151)	1.33 (6.60)	4.64 (14.42)
Dysphagia: C10D1(n= 47, 143)	1.42 (6.80)	5.36 (15.14)
Dysphagia: C11D1(n= 37, 130)	1.80 (7.64)	2.82 (11.01)
Dysphagia: C12D1(n= 29, 129)	2.30 (8.60)	3.88 (12.93)
Dysphagia: C13D1(n= 19, 121)	0.00 (0.00)	3.86 (11.54)
Dysphagia: C14D1(n= 18, 119)	5.56 (12.78)	5.04 (13.47)
Dysphagia: C15D1(n= 16, 110)	0.00 (0.00)	3.33 (11.01)
Dysphagia: C16D1(n= 13, 106)	0.00 (0.00)	3.77 (12.45)
Dysphagia: C17D1(n= 11, 95)	3.03 (10.05)	3.86 (13.63)
Dysphagia: C18D1(n= 10, 90)	0.00 (0.00)	4.44 (15.96)
Dysphagia: C19D1(n= 9, 82)	3.70 (11.11)	5.28 (15.24)
Dysphagia: C20D1(n= 9, 78)	0.00 (0.00)	4.70 (12.85)
Dysphagia: C21D1(n= 9, 73)	0.00 (0.00)	5.02 (15.39)
Dysphagia: C22D1(n= 8, 67)	0.00 (0.00)	2.99 (11.21)
Dysphagia: C23D1(n= 8, 64)	0.00 (0.00)	3.65 (12.05)
Dysphagia: C24D1(n= 5, 62)	0.00 (0.00)	4.84 (15.79)
Dysphagia: C25D1(n= 3, 58)	0.00 (0.00)	4.02 (15.39)
Dysphagia: C26D1(n= 3, 53)	0.00 (0.00)	4.40 (13.14)
Dysphagia: C27D1(n= 3, 50)	0.00 (0.00)	2.67 (11.35)
Dysphagia: C28D1(n= 2, 46)	0.00 (0.00)	4.35 (15.09)
Dysphagia: C29D1(n= 2, 38)	0.00 (0.00)	4.39 (13.80)
Dysphagia: C30D1(n= 1, 31)	0.00 (NA)	5.38 (15.15)
Dysphagia: C31D1(n= 0, 24)	NA (NA)	5.56 (21.23)
Dysphagia: C32D1(n= 0, 23)	NA (NA)	7.25 (17.28)
Dysphagia: C33D1(n= 0,16)	NA (NA)	6.25 (13.44)
Dysphagia: C34D1(n= 0, 14)	NA (NA)	9.52 (20.38)
Dysphagia: C35D1(n= 0, 11)	NA (NA)	3.03 (10.05)
Dysphagia: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Dysphagia: C37D1(n= 0, 5)	NA (NA)	6.67 (14.91)
Dysphagia: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Dysphagia: EOT(n= 264, 245)	10.23 (20.77)	8.98 (18.87)
Dysphagia: Pro Week 6 Pd(n= 0,1)	NA (NA)	0.00 (NA)
Dysphagia: Survival FU 1 (n= 2, 1)	0.00 (0.00)	0.00 (NA)

24. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Dyspnea
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for dyspnea.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Dyspnea: Baseline (n= 386, 407)	28.55 (23.21)	26.78 (22.43)
Dyspnea: C2D1(n= 335, 361)	28.14 (23.48)	28.79 (23.67)
Dyspnea: C3D1(n= 252, 301)	28.13 (22.45)	25.40 (20.60)
Dyspnea: C4D1(n= 220, 273)	27.75 (19.85)	25.17 (21.14)
Dyspnea: C5D1(n= 165, 236)	26.57 (19.61)	24.72 (19.90)
Dyspnea: C6D1(n= 148, 221)	29.69 (21.94)	24.01 (21.09)
Dyspnea: C7D1(n= 87, 187)	25.35 (21.07)	24.42 (21.23)
Dyspnea: C8D1(n=70, 167)	28.02 (24.12)	24.42 (22.33)
Dyspnea: C9D1(n= 50, 151)	26.00 (21.49)	22.44 (21.87)
Dyspnea: C10D1(n= 47, 143)	27.42 (22.56)	22.18 (21.35)
Dyspnea: C11D1(n= 37, 130)	22.67 (19.79)	20.43 (21.44)
Dyspnea: C12D1(n= 30, 129)	22.41 (18.94)	22.27 (20.47)
Dyspnea: C13D1(n= 19, 121)	16.37 (15.87)	22.22 (21.52)
Dyspnea: C14D1(n= 18, 119)	17.90 (12.13)	22.41 (20.66)
Dyspnea: C15D1(n= 16, 110)	15.28 (12.75)	22.12 (18.71)
Dyspnea: C16D1(n= 13, 106)	14.53 (13.13)	21.91 (20.71)
Dyspnea: C17D1(n= 10, 95)	18.89 (14.86)	23.51 (21.84)
Dyspnea: C18D1(n= 10, 90)	20.00 (12.61)	22.65 (21.97)
Dyspnea: C19D1(n= 9, 82)	18.52 (13.61)	22.09 (20.91)
Dyspnea: C20D1(n= 9, 78)	20.37 (15.21)	22.65 (21.37)
Dyspnea: C21D1(n= 9, 73)	19.75 (15.49)	20.40 (19.69)
Dyspnea: C22D1(n= 8, 67)	18.06 (20.52)	19.90 (17.68)
Dyspnea: C23D1(n= 8, 64)	16.67 (13.28)	21.2 (19.13)
Dyspnea: C24D1(n= 5, 62)	20.00 (14.49)	21.33 (20.94)
Dyspnea: C25D1(n= 3, 58)	29.63 (25.66)	19.73 (18.39)
Dyspnea: C26D1(n= 3, 53)	22.22 (11.11)	21.80 (19.97)
Dyspnea: C27D1(n= 3, 50)	18.52 (6.41)	20.33 (20.87)
Dyspnea: C28D1(n= 2, 46)	5.56 (7.86)	18.36 (17.87)
Dyspnea: C29D1(n= 2, 38)	5.56 (7.86)	19.30 (16.48)
Dyspnea: C30D1(n= 1, 31)	11.11 (NA)	17.92 (17.14)
Dyspnea: C31D1(n= 0, 24)	NA (NA)	24.07 (18.73)
Dyspnea: C32D1(n= 0, 23)	NA (NA)	24.15 (20.00)
Dyspnea: C33D1(n= 0,16)	NA (NA)	25.69 (27.13)
Dyspnea: C34D1(n= 0, 14)	NA (NA)	27.78 (22.96)
Dyspnea: C35D1(n= 0, 11)	NA (NA)	26.26 (19.42)
Dyspnea: C36D1(n= 0, 8)	NA (NA)	18.06 (13.20)
Dyspnea: C37D1(n= 0, 5)	NA (NA)	24.44 (4.97)
Dyspnea: C38D1(n= 0, 2)	NA (NA)	16.67 (7.86)
Dyspnea: EOT(n= 263, 246)	36.12 (24.82)	34.51 (26.36)
Dyspnea: Pro Week 6 Pd(n= 0,1)	NA (NA)	22.22 (NA)
Dyspnea: Survival FU 1 (n= 2, 1)	66.67 (15.71)	44.44 (NA)

25. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for hemoptysis.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Hemoptysis: Baseline (n= 386, 406)	4.32 (13.32)	3.86 (12.12)
Hemoptysis: C2D1(n= 336, 359)	4.76 (14.24)	3.16 (10.97)
Hemoptysis: C3D1(n= 251, 301)	4.38 (13.11)	3.10 (11.12)
Hemoptysis: C4D1(n= 220, 270)	2.88 (10.89)	2.10 (9.94)
Hemoptysis: C5D1(n= 163, 234)	1.43 (7.72)	1.42 (6.76)
Hemoptysis: C6D1(n= 148, 219)	1.80 (7.56)	1.22 (6.27)
Hemoptysis: C7D1(n= 87, 187)	1.15 (6.12)	1.43 (6.76)
Hemoptysis: C8D1(n=70, 166)	1.90 (9.64)	2.41 (10.09)
Hemoptysis: C9D1(n= 50, 151)	2.00 (8.00)	1.77 (7.49)
Hemoptysis: C10D1(n= 47, 143)	2.84 (9.40)	0.70 (4.79)
Hemoptysis: C11D1(n= 37, 130)	1.80 (7.64)	1.03 (5.78)
Hemoptysis: C12D1(n= 30, 129)	0.00 (0.00)	1.03 (5.80)
Hemoptysis: C13D1(n= 19, 121)	3.51 (10.51)	1.10 (5.98)
Hemoptysis: C14D1(n= 18, 119)	1.85 (7.86)	1.68 (7.32)
Hemoptysis: C15D1(n= 16, 110)	0.00 (0.00)	1.82 (10.91)
Hemoptysis: C16D1(n= 13, 106)	0.00 (0.00)	2.83 (10.41)
Hemoptysis: C17D1(n= 11, 94)	0.00 (0.00)	2.84 (12.61)
Hemoptysis: C18D1(n= 10, 90)	0.00 (0.00)	2.96 (12.88)
Hemoptysis: C19D1(n= 9, 82)	0.00 (0.00)	2.03 (12.11)
Hemoptysis: C20D1(n= 9, 78)	0.00 (0.00)	2.56 (12.90)
Hemoptysis: C21D1(n= 8, 73)	0.00 (0.00)	1.83 (7.64)
Hemoptysis: C22D1(n= 8, 67)	0.00 (0.00)	1.99 (9.85)
Hemoptysis: C23D1(n= 8, 64)	0.00 (0.00)	1.04 (5.85)
Hemoptysis: C24D1(n= 5, 61)	0.00 (0.00)	2.73 (11.05)
Hemoptysis: C25D1(n= 3, 58)	0.00 (0.00)	3.45 (13.52)
Hemoptysis: C26D1(n= 3, 53)	0.00 (0.00)	3.77 (14.11)
Hemoptysis: C27D1(n= 3, 50)	0.00 (0.00)	2.00 (8.00)
Hemoptysis: C28D1(n= 2, 46)	33.33 (47.14)	1.45 (6.87)
Hemoptysis: C29D1(n= 2, 38)	0.00 (0.00)	0.88 (5.41)
Hemoptysis: C30D1(n= 1, 31)	0.00 (NA)	1.08 (5.99)
Hemoptysis: C31D1(n= 0, 24)	NA (NA)	2.78 (9.41)
Hemoptysis: C32D1(n= 0, 23)	NA (NA)	2.90 (9.60)
Hemoptysis: C33D1(n= 0,16)	NA (NA)	0.00 (0.00)
Hemoptysis: C34D1(n= 0, 14)	NA (NA)	0.00 (0.00)
Hemoptysis: C35D1(n= 0, 11)	NA (NA)	0.00 (0.00)
Hemoptysis: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Hemoptysis: C37D1(n= 0, 5)	NA (NA)	0.00 (0.00)
Hemoptysis: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Hemoptysis: EOT(n= 264, 243)	5.18 (14.33)	6.04 (16.60)
Hemoptysis: Pro Week 6 Pd(n= 0,1)	NA (NA)	0.00 (NA)
Hemoptysis: Survival FU 1 (n= 2, 1)	33.33 (47.14)	0.00 (NA)

26. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in arm or shoulder.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Pain in Arm or Shoulder: Baseline (n= 384, 405)	20.49 (28.85)	20.16 (27.09)
Pain in Arm or Shoulder: C2D1(n= 332, 358)	19.58 (27.45)	18.34 (26.56)
Pain in Arm or Shoulder: C3D1(n= 248, 294)	17.20 (27.16)	16.44 (25.50)
Pain in Arm or Shoulder: C4D1(n= 217, 270)	14.75 (23.74)	18.15 (26.57)
Pain in Arm or Shoulder: C5D1(n= 164, 232)	16.06 (24.06)	14.94 (23.76)
Pain in Arm or Shoulder: C6D1(n= 147, 219)	15.42 (23.17)	15.68 (24.37)
Pain in Arm or Shoulder: C7D1(n= 86, 184)	14.73 (23.77)	16.67 (26.31)
Pain in Arm or Shoulder: C8D1(n=69, 163)	15.94 (25.95)	16.77 (25.22)
Pain in Arm or Shoulder: C9D1(n= 50, 149)	14.00 (24.36)	16.78 (25.89)
Pain in Arm or Shoulder: C10D1(n= 46, 141)	14.49 (20.67)	17.73 (27.18)
Pain in Arm or Shoulder: C11D1(n= 36, 127)	11.11 (19.52)	15.49 (26.82)
Pain in Arm or Shoulder: C12D1(n= 30, 126)	12.22 (18.54)	16.93 (26.91)
Pain in Arm or Shoulder: C13D1(n= 19, 117)	12.28 (19.91)	14.81 (22.93)
Pain in Arm or Shoulder: C14D1(n= 18, 117)	11.11 (19.80)	15.67 (22.56)
Pain in Arm or Shoulder: C15D1(n= 16, 108)	12.50 (20.64)	15.74 (24.31)
Pain in Arm or Shoulder: C16D1(n= 13, 104)	7.69 (14.62)	14.10 (23.54)
Pain in Arm or Shoulder: C17D1(n= 11, 93)	9.09 (15.57)	16.49 (25.83)
Pain in Arm or Shoulder: C18D1(n= 10, 88)	13.33 (23.31)	18.18 (25.73)
Pain in Arm or Shoulder: C19D1(n= 9, 80)	7.41 (14.70)	20.83 (29.23)
Pain in Arm or Shoulder: C20D1(n= 9, 76)	11.11 (23.57)	18.42 (25.18)
Pain in Arm or Shoulder: C21D1(n= 9, 71)	11.11 (16.67)	12.68 (19.81)
Pain in Arm or Shoulder: C22D1(n= 8, 65)	16.67 (25.20)	13.33 (21.89)
Pain in Arm or Shoulder: C23D1(n= 8, 62)	16.67 (25.20)	15.05 (22.32)
Pain in Arm or Shoulder: C24D1(n= 5, 59)	20.00 (29.81)	18.08 (24.23)
Pain in Arm or Shoulder: C25D1(n= 3, 57)	11.11 (19.24)	14.62 (21.84)
Pain in Arm or Shoulder: C26D1(n= 2, 52)	16.67 (23.57)	15.38 (22.35)
Pain in Arm or Shoulder: C27D1(n= 3, 49)	11.11 (19.24)	14.97 (23.63)
Pain in Arm or Shoulder: C28D1(n= 2, 45)	0.00 (0.00)	11.85 (19.01)
Pain in Arm or Shoulder: C29D1(n= 2, 37)	0.00 (0.00)	10.81 (22.30)
Pain in Arm or Shoulder: C30D1(n= 1, 30)	0.00 (NA)	10.00 (21.71)
Pain in Arm or Shoulder: C31D1(n= 0, 23)	NA (NA)	10.14 (21.17)
Pain in Arm or Shoulder: C32D1(n= 0, 22)	NA (NA)	13.64 (26.55)
Pain in Arm or Shoulder: C33D1(n= 0, 15)	NA (NA)	20.00 (27.60)
Pain in Arm or Shoulder: C34D1(n= 0, 14)	NA (NA)	16.67 (28.49)
Pain in Arm or Shoulder: C35D1(n= 0, 11)	NA (NA)	27.27 (32.72)
Pain in Arm or Shoulder: C36D1(n= 0, 8)	NA (NA)	16.67 (35.63)
Pain in Arm or Shoulder: C37D1(n= 0, 5)	NA (NA)	33.33 (47.14)
Pain in Arm or Shoulder: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Pain in Arm or Shoulder: EOT(n= 264, 242)	21.72 (30.48)	23.14 (29.55)
Pain in Arm or Shoulder: Pro Week 6 Pd(n= 0,1)	NA (NA)	66.67 (NA)
Pain in Arm or Shoulder: Survival FU 1 (n= 2, 1)	83.33 (23.57)	33.33 (NA)

27. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in chest.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Pain in Chest: Baseline (n= 385, 403)	17.92 (25.33)	19.52 (26.49)
Pain in Chest: C2D1(n= 332, 356)	16.67 (24.65)	15.26 (22.68)
Pain in Chest: C3D1(n= 249, 296)	14.59 (21.92)	15.43 (23.42)
Pain in Chest: C4D1(n= 217, 268)	14.44 (22.37)	14.43 (23.77)
Pain in Chest: C5D1(n= 164, 233)	11.99 (18.42)	12.16 (19.82)
Pain in Chest: C6D1(n= 145, 217)	12.18 (19.96)	12.60 (21.40)
Pain in Chest: C7D1(n= 86, 184)	12.40 (19.83)	11.78 (20.91)
Pain in Chest: C8D1(n=69, 164)	10.63 (20.21)	14.02 (21.52)
Pain in Chest: C9D1(n= 49, 149)	7.48 (17.03)	10.74 (20.96)
Pain in Chest: C10D1(n= 46, 142)	5.07 (12.11)	8.45 (19.62)
Pain in Chest: C11D1(n= 36, 127)	3.70 (10.62)	9.45 (22.18)
Pain in Chest: C12D1(n= 30, 128)	3.33 (10.17)	8.85 (17.49)
Pain in Chest: C13D1(n= 19, 120)	3.51 (10.51)	7.50 (16.99)
Pain in Chest: C14D1(n= 18, 118)	5.56 (12.78)	7.63 (15.96)
Pain in Chest: C15D1(n= 16, 109)	6.25 (13.44)	8.56 (18.37)
Pain in Chest: C16D1(n= 13, 105)	5.13 (12.52)	8.25 (16.53)
Pain in Chest: C17D1(n= 11, 94)	0.00 (0.00)	8.87 (20.84)
Pain in Chest: C18D1(n= 10, 89)	6.67 (14.05)	7.49 (15.69)
Pain in Chest: C19D1(n= 9, 80)	7.41 (14.70)	7.50 (19.10)
Pain in Chest: C20D1(n= 9, 76)	3.70 (11.11)	10.09 (20.38)
Pain in Chest: C21D1(n= 9, 71)	0.00 (0.00)	7.98 (15.39)
Pain in Chest: C22D1(n= 8, 66)	4.17 (11.78)	7.58 (16.33)
Pain in Chest: C23D1(n= 8, 62)	4.17 (11.78)	7.53 (17.51)
Pain in Chest: C24D1(n= 5, 61)	0.00 (0.00)	8.20 (15.70)
Pain in Chest: C25D1(n= 3, 57)	0.00 (0.00)	8.77 (16.09)
Pain in Chest: C26D1(n= 2, 52)	0.00 (0.00)	10.90 (19.49)
Pain in Chest: C27D1(n= 3, 49)	11.11 (19.24)	8.84 (18.97)
Pain in Chest: C28D1(n= 2, 45)	0.00 (0.00)	8.15 (16.14)
Pain in Chest: C29D1(n= 2, 37)	0.00 (0.00)	8.11 (16.49)
Pain in Chest: C30D1(n= 1, 31)	0.00 (NA)	5.38 (12.46)
Pain in Chest: C31D1(n= 0, 24)	NA (NA)	4.17 (11.26)
Pain in Chest: C32D1(n= 0, 23)	NA (NA)	13.04 (19.43)
Pain in Chest: C33D1(n= 0, 16)	NA (NA)	14.58 (24.25)
Pain in Chest: C34D1(n= 0, 14)	NA (NA)	14.29 (25.20)
Pain in Chest: C35D1(n= 0, 11)	NA (NA)	6.06 (13.48)
Pain in Chest: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Pain in Chest: C37D1(n= 0, 5)	NA (NA)	6.67 (14.91)
Pain in Chest: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Pain in Chest: EOT(n= 265, 245)	18.99 (26.35)	19.46 (26.95)
Pain in Chest: Pro Week 6 Pd(n= 0,1)	NA (NA)	0.00 (NA)
Pain in Chest: Survival FU 1 (n= 2, 1)	50.00 (70.71)	33.33 (NA)

28. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for peripheral neuropathy.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Peripheral Neuropathy: Baseline (n= 386, 406)	19.26 (28.94)	19.21 (27.77)
Peripheral Neuropathy: C2D1(n= 335, 358)	25.57 (29.63)	20.02 (27.21)
Peripheral Neuropathy: C3D1(n= 250, 300)	25.60 (29.16)	17.78 (25.04)
Peripheral Neuropathy: C4D1(n= 221, 272)	28.05 (29.94)	17.77 (25.75)
Peripheral Neuropathy: C5D1(n= 165, 235)	29.29 (28.94)	18.44 (25.97)
Peripheral Neuropathy: C6D1(n= 147, 221)	31.97 (30.69)	17.50 (25.34)
Peripheral Neuropathy: C7D1(n= 86, 185)	31.01 (30.59)	18.02 (25.29)
Peripheral Neuropathy: C8D1(n=70, 167)	35.24 (26.55)	17.56 (25.30)
Peripheral Neuropathy: C9D1(n= 50, 150)	36.00 (29.23)	15.78 (24.02)
Peripheral Neuropathy: C10D1(n= 47, 143)	36.17 (30.16)	18.18 (25.86)
Peripheral Neuropathy: C11D1(n= 37, 129)	27.93 (24.23)	17.05 (24.69)
Peripheral Neuropathy: C12D1(n= 30, 129)	30.00 (25.30)	17.57 (23.96)
Peripheral Neuropathy: C13D1(n= 19, 121)	26.32 (21.02)	17.91 (25.83)
Peripheral Neuropathy: C14D1(n= 18, 119)	25.93 (21.56)	17.09 (23.72)
Peripheral Neuropathy: C15D1(n= 15, 110)	24.44 (15.26)	17.58 (21.99)
Peripheral Neuropathy: C16D1(n= 13, 105)	20.51 (16.88)	17.14 (24.07)
Peripheral Neuropathy: C17D1(n= 11, 95)	21.21 (16.82)	19.30 (26.44)
Peripheral Neuropathy: C18D1(n= 10, 90)	23.33 (22.50)	18.15 (26.52)
Peripheral Neuropathy: C19D1(n= 9, 82)	14.81 (17.57)	20.33 (26.06)
Peripheral Neuropathy: C20D1(n= 9, 78)	22.22 (23.57)	17.52 (26.17)
Peripheral Neuropathy: C21D1(n= 9, 73)	29.63 (20.03)	18.72 (25.45)
Peripheral Neuropathy: C22D1(n= 7, 66)	23.81 (16.26)	15.66 (23.55)
Peripheral Neuropathy: C23D1(n= 8, 64)	16.67 (17.82)	20.31 (22.71)
Peripheral Neuropathy: C24D1(n= 5, 62)	13.33 (18.26)	20.43 (22.87)
Peripheral Neuropathy: C25D1(n= 3, 58)	11.11 (19.24)	18.39 (20.87)
Peripheral Neuropathy: C26D1(n= 2, 53)	16.67 (23.57)	20.13 (25.60)
Peripheral Neuropathy: C27D1(n= 3, 50)	11.11 (19.24)	19.33 (24.36)
Peripheral Neuropathy: C28D1(n= 2, 46)	0.00 (0.00)	19.57 (22.85)
Peripheral Neuropathy: C29D1(n= 2, 38)	0.00 (0.00)	19.30 (22.77)
Peripheral Neuropathy: C30D1(n= 1, 31)	0.00 (NA)	20.43 (28.12)
Peripheral Neuropathy: C31D1(n= 0, 24)	NA (NA)	23.61 (26.88)
Peripheral Neuropathy: C32D1(n= 0, 23)	NA (NA)	18.84 (22.08)
Peripheral Neuropathy: C33D1(n= 0, 16)	NA (NA)	22.92 (20.07)
Peripheral Neuropathy: C34D1(n= 0, 14)	NA (NA)	19.05 (21.54)
Peripheral Neuropathy: C35D1(n= 0, 11)	NA (NA)	15.15 (17.41)
Peripheral Neuropathy: C36D1(n= 0, 8)	NA (NA)	8.33 (15.43)
Peripheral Neuropathy: C37D1(n= 0, 5)	NA (NA)	26.67 (27.89)
Peripheral Neuropathy: C38D1(n= 0, 2)	NA (NA)	16.67 (23.57)
Peripheral Neuropathy: EOT(n= 262, 244)	31.81 (31.53)	19.54 (27.32)
Peripheral Neuropathy: Pro Week 6 Pd(n= 0,1)	NA (NA)	66.67 (NA)
Peripheral Neuropathy: Survival FU 1 (n= 2, 1)	50.00 (23.57)	33.33 (NA)

29. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for pain in other parts.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Pain in Other Parts: Baseline (n= 373, 402)	27.52 (30.41)	27.94 (31.52)
Pain in Other Parts: C2D1(n= 320, 347)	29.58 (30.44)	27.76 (30.53)
Pain in Other Parts: C3D1(n= 239, 286)	22.87 (27.79)	25.87 (29.79)
Pain in Other Parts: C4D1(n= 211, 263)	21.48 (26.86)	23.45 (26.92)
Pain in Other Parts: C5D1(n= 154, 230)	21.21 (26.63)	22.32 (27.24)
Pain in Other Parts: C6D1(n= 139, 214)	22.78 (25.39)	21.50 (27.88)
Pain in Other Parts: C7D1(n= 81, 180)	23.05 (28.21)	24.63 (29.56)
Pain in Other Parts: C8D1(n=65, 158)	24.10 (28.57)	18.35 (24.54)
Pain in Other Parts: C9D1(n= 44, 135)	18.18 (28.26)	21.48 (28.35)
Pain in Other Parts: C10D1(n= 44, 136)	15.15 (23.24)	21.57 (28.84)
Pain in Other Parts: C11D1(n= 34, 123)	14.71 (23.49)	20.05 (27.90)
Pain in Other Parts: C12D1(n= 26, 122)	8.97 (17.78)	16.67 (25.80)
Pain in Other Parts: C13D1(n= 17, 113)	17.65 (23.91)	19.76 (25.05)
Pain in Other Parts: C14D1(n= 18, 115)	18.52 (23.49)	22.03 (29.58)
Pain in Other Parts: C15D1(n= 15, 106)	6.67 (13.80)	19.18 (25.18)
Pain in Other Parts: C16D1(n= 13, 105)	20.51 (21.68)	21.90 (26.89)
Pain in Other Parts: C17D1(n= 11, 93)	15.15 (22.92)	22.22 (27.51)
Pain in Other Parts: C18D1(n= 10, 89)	13.33 (23.31)	22.10 (27.50)
Pain in Other Parts: C19D1(n= 9, 80)	18.52 (24.22)	24.58 (29.88)
Pain in Other Parts: C20D1(n= 9, 74)	25.93 (36.43)	21.17 (27.90)
Pain in Other Parts: C21D1(n= 8, 69)	12.50 (17.25)	21.26 (31.30)
Pain in Other Parts: C22D1(n= 8, 62)	20.83 (24.80)	18.82 (25.34)
Pain in Other Parts: C23D1(n= 8, 62)	20.83 (30.54)	18.82 (23.86)
Pain in Other Parts: C24D1(n= 5, 61)	26.67 (43.46)	19.67 (28.14)
Pain in Other Parts: C25D1(n= 3, 55)	11.11 (19.24)	16.97 (26.35)
Pain in Other Parts: C26D1(n= 2, 50)	16.67 (23.57)	18.67 (26.22)
Pain in Other Parts: C27D1(n= 3, 49)	11.11 (19.24)	14.29 (21.52)
Pain in Other Parts: C28D1(n= 2, 44)	0.00 (0.00)	15.15 (25.37)
Pain in Other Parts: C29D1(n= 2, 36)	0.00 (0.00)	21.30 (26.61)
Pain in Other Parts: C30D1(n= 1, 30)	0.00 (NA)	16.67 (30.01)
Pain in Other Parts: C31D1(n= 0, 23)	NA (NA)	11.59 (21.58)
Pain in Other Parts: C32D1(n= 0, 23)	NA (NA)	20.29 (27.96)
Pain in Other Parts: C33D1(n= 0, 15)	NA (NA)	11.11 (27.22)
Pain in Other Parts: C34D1(n= 0, 14)	NA (NA)	30.95 (33.24)
Pain in Other Parts: C35D1(n= 0, 10)	NA (NA)	26.67 (34.43)
Pain in Other Parts: C36D1(n= 0, 8)	NA (NA)	20.83 (35.36)
Pain in Other Parts: C37D1(n= 0, 5)	NA (NA)	33.33 (40.82)
Pain in Other Parts: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Pain in Other Parts: EOT(n= 250, 226)	30.80 (32.97)	32.01 (33.89)
Pain in Other Parts: Pro Week 6 Pd(n= 0,1)	NA (NA)	0.00 (NA)
Pain in Other Parts: Survival FU 1 (n= 2, 1)	83.33 (23.57)	66.67 (NA)

30. Secondary Outcome

Title	EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
Description	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy experienced during past 1 week. The 13 questions comprised 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts. Response range: (1) not at all to (4) very much. Scores for each item were transformed to 0 to 100, where higher symptom score = greater degree of symptoms. Results have been reported for sore mouth.
Time Frame	Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)

Outcome Measure Data

Analysis Population Description

The PP-ITT analysis set. Here, 'n' signifies those participants evaluated for this measure at specific time point for each group respectively. All 850 participants contributed to the endpoint but not all completed evaluation of every timepoint. Convention 'CxDx' refers to cycle number and day number.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	425	425
Sore Mouth: Baseline (n= 387, 404)	5.68 (16.34)	4.95 (15.32)
Sore Mouth: C2D1(n= 335, 357)	15.52 (25.75)	7.10 (18.17)
Sore Mouth: C3D1(n= 252, 297)	14.29 (23.59)	5.61 (14.18)
Sore Mouth: C4D1(n= 219, 270)	14.00 (22.95)	4.81 (13.99)
Sore Mouth: C5D1(n= 165, 234)	11.31 (19.65)	4.27 (13.49)
Sore Mouth: C6D1(n= 148, 218)	13.29 (23.24)	4.13 (13.89)
Sore Mouth: C7D1(n= 87, 185)	9.20 (20.77)	5.59 (15.50)
Sore Mouth: C8D1(n=70, 166)	8.57 (16.73)	5.02 (14.96)
Sore Mouth: C9D1(n= 50, 151)	6.00 (17.42)	3.09 (14.06)
Sore Mouth: C10D1(n= 47, 143)	7.09 (15.44)	3.96 (14.53)
Sore Mouth: C11D1(n= 37, 130)	4.50 (13.97)	3.33 (12.35)
Sore Mouth: C12D1(n= 30, 129)	2.22 (8.46)	4.65 (14.87)
Sore Mouth: C13D1(n= 19, 121)	1.75 (7.65)	5.23 (15.52)
Sore Mouth: C14D1(n= 18, 119)	3.70 (10.78)	5.32 (15.64)
Sore Mouth: C15D1(n= 15, 110)	0.00 (0.00)	4.24 (13.63)
Sore Mouth: C16D1(n= 13, 106)	0.00 (0.00)	3.77 (16.15)
Sore Mouth: C17D1(n= 11, 95)	3.03 (10.05)	6.32 (17.73)
Sore Mouth: C18D1(n= 10, 90)	3.33 (10.54)	3.70 (11.66)
Sore Mouth: C19D1(n= 9, 82)	0.00 (0.00)	4.47 (12.57)
Sore Mouth: C20D1(n= 9, 78)	0.00 (0.00)	5.56 (15.59)
Sore Mouth: C21D1(n= 9, 73)	0.00 (0.00)	7.76 (17.14)
Sore Mouth: C22D1(n= 8, 67)	4.17 (11.78)	6.47 (17.64)
Sore Mouth: C23D1(n= 8, 64)	4.17 (11.78)	6.25 (16.67)
Sore Mouth: C24D1(n= 5, 62)	0.00 (0.00)	5.38 (13.75)
Sore Mouth: C25D1(n= 3, 57)	0.00 (0.00)	3.51 (10.32)
Sore Mouth: C26D1(n= 3, 53)	0.00 (0.00)	6.92 (13.65)
Sore Mouth: C27D1(n= 3, 50)	0.00 (0.00)	4.00 (10.94)
Sore Mouth: C28D1(n= 2, 46)	0.00 (0.00)	4.35 (11.35)
Sore Mouth: C29D1(n= 2, 38)	0.00 (0.00)	3.51 (10.37)
Sore Mouth: C30D1(n= 1, 31)	0.00 (NA)	4.30 (11.36)
Sore Mouth: C31D1(n= 0, 24)	NA (NA)	4.17 (11.26)
Sore Mouth: C32D1(n= 0, 23)	NA (NA)	4.35 (11.48)
Sore Mouth: C33D1(n= 0, 16)	NA (NA)	4.17 (11.39)
Sore Mouth: C34D1(n= 0, 14)	NA (NA)	9.52 (15.63)
Sore Mouth: C35D1(n= 0, 11)	NA (NA)	6.06 (13.48)
Sore Mouth: C36D1(n= 0, 8)	NA (NA)	4.17 (11.78)
Sore Mouth: C37D1(n= 0, 5)	NA (NA)	13.33 (29.81)
Sore Mouth: C38D1(n= 0, 2)	NA (NA)	0.00 (0.00)
Sore Mouth: EOT(n= 265, 243)	11.57 (22.85)	7.00 (17.18)
Sore Mouth: Pro Week 6 Pd(n= 0,1)	NA (NA)	66.67 (NA)
Sore Mouth: Survival FU 1 (n= 2, 1)	16.67 (23.57)	0.00 (NA)

31. Primary Outcome

Title	OS: SP-ITT
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

Secondary population (SP) ITT analysis set included all 1225 randomized participants regardless of whether they received any study drug.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	612	613
Median (95% Confidence Interval) [Months]	9.8	13.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.70 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

32. Primary Outcome

Title	OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death from any cause (approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

TC1/2/3 Or IC1/2/3 Subgroup of SP.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	337	347
Median (95% Confidence Interval) [Months]	10.8	14.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0045
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.77
	Confidence Interval	(2-Sided) 95%; 0.64 to 0.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

33. Primary Outcome

Title	OS: TC2/3 or IC2/3 Subgroup of SP
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

TC2/3 or IC2/3 Subgroup of SP.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	182	168
Median (95% Confidence Interval) [Months]	11.4	16.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0012
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95%; 0.49 to 0.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

34. Primary Outcome

Title	OS: TC3 or IC3 Subgroup of SP
Description	OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Participants who had no post-baseline information were censored at the date of randomization plus 1 day. OS was estimated using KM methodology.
Time Frame	Baseline until death due to any cause (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

TC3 or IC3 Subgroup of SP.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	85	89
Median (95% Confidence Interval) [Months]	9.7	20.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments	Stratified analysis based on the strata of IC levels per interactive voice/web response system (IxRS), the number of prior chemotherapy regimens per IxRS, and histology per electronic case report form (eCRF).
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.45
	Confidence Interval	(2-Sided) 95%; 0.30 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

35. Secondary Outcome

Title	PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
Description	PFS is defined as the time between the date of randomization and the date of first documented PD or death, whichever occurs first. Participants who are alive and have not experienced PD at the time of analysis were censored at the time of the last tumor assessment. Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, or presence of new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

SP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	612	613
Median (95% Confidence Interval) [Months]	3.8	2.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.4981
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Stratified Hazard Ratio
	Estimated Value	0.96
	Confidence Interval	(2-Sided) 95%; 0.85 to 1.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

36. Secondary Outcome

Title	Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
Description	Objective response is defined as a complete response (CR) or partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 mm). No new lesions. At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR. No new lesions.
Time Frame	Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

SP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	612	613
Number (95% Confidence Interval) [Percentage of Participants]	11.8 1.9%	13.7 2.2%

37. Secondary Outcome

Title	DOR as Determined by Investigator Using RECIST v1.1: SP ITT
Description	DOR:Duration from the first tumor assessment that supports the participant's objective response to PD or death due to any cause,whichever occurs first.CR:complete disappearance of all target lesions and non-target disease.All nodes,both target and non-target,must decrease to normal. No new lesions.PR: At least a 30% decrease in the sum of the diameters of all target and all new measurable lesions, taking as reference the baseline sum of diameters, in the absence of CR.Participants who have not experienced PD at the time of analysis were censored at the time of the last tumor assessment.Participants with no post-baseline tumor assessment were censored at the randomization date plus 1 day.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm,progression of existing non-target lesions,or presence of new lesions.DOR was estimated using KM methodology.
Time Frame	From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)

Outcome Measure Data

Analysis Population Description

The SP-ITT analysis set.

Arm/Group Title	Docetaxel	Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.	Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
Measure Participants	72	84
Median (95% Confidence Interval) [Months]	6.3	23.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Docetaxel, Atezolizumab
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Unstratified Hazard Ratio
	Estimated Value	0.32
	Confidence Interval	(2-Sided) 95%; 0.21 to 0.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Baseline up to approximately 5.28 years.
Adverse Event Reporting Description	Safety evaluable population included all randomized participants who received any dose of study drug. Analysis was performed according to actual treatment received. One participant randomized to docetaxel received atezolizumab and hence included in atezolizumab arm.
Arm/Group Title	Docetaxel		Atezolizumab
Arm/Group Description	Docetaxel 75 milligrams per square meter (mg/m^2) was administered intravenously (IV) on Day 1 of each 21-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.		Atezolizumab 1200 mg was administered IV on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurred first.
All Cause Mortality
	Docetaxel		Atezolizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Docetaxel		Atezolizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	180/578 (31.1%)		200/609 (32.8%)
Blood and lymphatic system disorders
Anaemia	7/578 (1.2%)		5/609 (0.8%)
Febrile neutropenia	37/578 (6.4%)		0/609 (0%)
Leukocytosis	1/578 (0.2%)		0/609 (0%)
Neutropenia	3/578 (0.5%)		0/609 (0%)
Cardiac disorders
Acute myocardial infarction	2/578 (0.3%)		0/609 (0%)
Angina pectoris	1/578 (0.2%)		0/609 (0%)
Arrhythmia	1/578 (0.2%)		0/609 (0%)
Atrial fibrillation	3/578 (0.5%)		1/609 (0.2%)
Atrial flutter	1/578 (0.2%)		0/609 (0%)
Cardiac arrest	1/578 (0.2%)		0/609 (0%)
Cardiac tamponade	0/578 (0%)		2/609 (0.3%)
Left ventricular dysfunction	0/578 (0%)		1/609 (0.2%)
Myocardial infarction	0/578 (0%)		2/609 (0.3%)
Myocardial ischaemia	0/578 (0%)		1/609 (0.2%)
Pericardial effusion	1/578 (0.2%)		3/609 (0.5%)
Pericarditis	0/578 (0%)		1/609 (0.2%)
Stress cardiomyopathy	1/578 (0.2%)		0/609 (0%)
Supraventricular tachycardia	2/578 (0.3%)		0/609 (0%)
Tachycardia	1/578 (0.2%)		1/609 (0.2%)
Tachycardia paroxysmal	0/578 (0%)		1/609 (0.2%)
Cardiac failure congestive	0/578 (0%)		1/609 (0.2%)
Eye disorders
Retinopathy	0/578 (0%)		1/609 (0.2%)
Gastrointestinal disorders
Abdominal pain	4/578 (0.7%)		1/609 (0.2%)
Abdominal pain lower	0/578 (0%)		2/609 (0.3%)
Abdominal pain upper	1/578 (0.2%)		1/609 (0.2%)
Colitis	2/578 (0.3%)		2/609 (0.3%)
Constipation	0/578 (0%)		1/609 (0.2%)
Diarrhoea	7/578 (1.2%)		1/609 (0.2%)
Duodenal perforation	1/578 (0.2%)		0/609 (0%)
Dysphagia	1/578 (0.2%)		1/609 (0.2%)
Faeces discoloured	0/578 (0%)		1/609 (0.2%)
Gastritis erosive	0/578 (0%)		1/609 (0.2%)
Haematochezia	1/578 (0.2%)		0/609 (0%)
Intestinal obstruction	0/578 (0%)		1/609 (0.2%)
Lower gastrointestinal haemorrhage	1/578 (0.2%)		0/609 (0%)
Melaena	0/578 (0%)		1/609 (0.2%)
Nausea	1/578 (0.2%)		2/609 (0.3%)
Oesophageal fistula	1/578 (0.2%)		0/609 (0%)
Oesophageal obstruction	0/578 (0%)		1/609 (0.2%)
Oesophageal varices haemorrhage	1/578 (0.2%)		0/609 (0%)
Pancreatitis	0/578 (0%)		1/609 (0.2%)
Stomatitis	1/578 (0.2%)		0/609 (0%)
Subileus	1/578 (0.2%)		0/609 (0%)
Upper gastrointestinal haemorrhage	1/578 (0.2%)		0/609 (0%)
Vomiting	5/578 (0.9%)		1/609 (0.2%)
Small intestinal obstruction	1/578 (0.2%)		1/609 (0.2%)
General disorders
Asthenia	3/578 (0.5%)		3/609 (0.5%)
Chest discomfort	0/578 (0%)		1/609 (0.2%)
Chest pain	1/578 (0.2%)		0/609 (0%)
Death	0/578 (0%)		1/609 (0.2%)
Fatigue	4/578 (0.7%)		2/609 (0.3%)
General physical health deterioration	0/578 (0%)		2/609 (0.3%)
Generalised oedema	1/578 (0.2%)		0/609 (0%)
Influenza like illness	0/578 (0%)		1/609 (0.2%)
Localised oedema	0/578 (0%)		1/609 (0.2%)
Oedema peripheral	0/578 (0%)		2/609 (0.3%)
Pain	1/578 (0.2%)		0/609 (0%)
Pyrexia	8/578 (1.4%)		9/609 (1.5%)
Sudden death	2/578 (0.3%)		1/609 (0.2%)
Systemic inflammatory response syndrome	0/578 (0%)		1/609 (0.2%)
Hepatobiliary disorders
Acute hepatic failure	1/578 (0.2%)		0/609 (0%)
Cholecystitis	1/578 (0.2%)		0/609 (0%)
Cholecystitis acute	1/578 (0.2%)		1/609 (0.2%)
Drug-induced liver injury	0/578 (0%)		1/609 (0.2%)
Hepatitis	0/578 (0%)		2/609 (0.3%)
Hepatitis acute	0/578 (0%)		1/609 (0.2%)
Immune system disorders
Hypersensitivity	0/578 (0%)		3/609 (0.5%)
Infections and infestations
Abdominal sepsis	1/578 (0.2%)		0/609 (0%)
Appendicitis	1/578 (0.2%)		0/609 (0%)
Bacterial sepsis	1/578 (0.2%)		0/609 (0%)
Bronchitis	2/578 (0.3%)		1/609 (0.2%)
Cellulitis	2/578 (0.3%)		1/609 (0.2%)
Clostridium difficile colitis	1/578 (0.2%)		0/609 (0%)
Clostridium difficile infection	0/578 (0%)		1/609 (0.2%)
Device related infection	1/578 (0.2%)		1/609 (0.2%)
Diverticulitis	2/578 (0.3%)		0/609 (0%)
Encephalitis	0/578 (0%)		1/609 (0.2%)
Enteritis infectious	0/578 (0%)		1/609 (0.2%)
Febrile infection	0/578 (0%)		1/609 (0.2%)
Gastroenteritis	1/578 (0.2%)		1/609 (0.2%)
Gastrointestinal fungal infection	1/578 (0.2%)		0/609 (0%)
Gastrointestinal infection	1/578 (0.2%)		0/609 (0%)
Infected skin ulcer	0/578 (0%)		1/609 (0.2%)
Infection	2/578 (0.3%)		0/609 (0%)
Infectious pleural effusion	0/578 (0%)		1/609 (0.2%)
Infective exacerbation of chronic obstructive airways disease	0/578 (0%)		1/609 (0.2%)
Influenza	1/578 (0.2%)		2/609 (0.3%)
Lower respiratory tract infection	3/578 (0.5%)		3/609 (0.5%)
Lung infection	3/578 (0.5%)		3/609 (0.5%)
Meningitis	0/578 (0%)		3/609 (0.5%)
Neutropenic sepsis	2/578 (0.3%)		0/609 (0%)
Paronychia	1/578 (0.2%)		0/609 (0%)
Parotitis	0/578 (0%)		1/609 (0.2%)
Pharyngitis	0/578 (0%)		2/609 (0.3%)
Pleural infection	1/578 (0.2%)		0/609 (0%)
Pneumocystis jirovecii pneumonia	0/578 (0%)		1/609 (0.2%)
Pneumonia	34/578 (5.9%)		20/609 (3.3%)
Pneumonia bacterial	0/578 (0%)		1/609 (0.2%)
Pseudomembranous colitis	0/578 (0%)		1/609 (0.2%)
Pulmonary sepsis	0/578 (0%)		2/609 (0.3%)
Respiratory tract infection	4/578 (0.7%)		8/609 (1.3%)
Sepsis	2/578 (0.3%)		5/609 (0.8%)
Septic shock	1/578 (0.2%)		1/609 (0.2%)
Skin infection	1/578 (0.2%)		0/609 (0%)
Tonsillitis	0/578 (0%)		1/609 (0.2%)
Upper respiratory tract infection bacterial	0/578 (0%)		1/609 (0.2%)
Urinary tract infection	2/578 (0.3%)		0/609 (0%)
Urosepsis	0/578 (0%)		1/609 (0.2%)
Gastroenteritis viral	0/578 (0%)		1/609 (0.2%)
Localised infection	0/578 (0%)		1/609 (0.2%)
Pyelonephritis	0/578 (0%)		1/609 (0.2%)
Injury, poisoning and procedural complications
Burns third degree	0/578 (0%)		1/609 (0.2%)
Fall	1/578 (0.2%)		1/609 (0.2%)
Hip fracture	0/578 (0%)		3/609 (0.5%)
Humerus fracture	1/578 (0.2%)		1/609 (0.2%)
Infusion related reaction	0/578 (0%)		1/609 (0.2%)
Lumbar vertebral fracture	0/578 (0%)		1/609 (0.2%)
Overdose	1/578 (0.2%)		0/609 (0%)
Post procedural haematuria	1/578 (0.2%)		0/609 (0%)
Radius fracture	0/578 (0%)		1/609 (0.2%)
Spinal compression fracture	0/578 (0%)		1/609 (0.2%)
Upper limb fracture	1/578 (0.2%)		0/609 (0%)
Ankle fracture	0/578 (0%)		1/609 (0.2%)
Femoral neck fracture	0/578 (0%)		1/609 (0.2%)
Fracture displacement	1/578 (0.2%)		0/609 (0%)
Investigations
Alanine aminotransferase increased	0/578 (0%)		1/609 (0.2%)
Aspartate aminotransferase increased	0/578 (0%)		1/609 (0.2%)
Neutrophil count decreased	5/578 (0.9%)		0/609 (0%)
White blood cell count decreased	1/578 (0.2%)		0/609 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/578 (0.2%)		0/609 (0%)
Dehydration	3/578 (0.5%)		1/609 (0.2%)
Failure to thrive	0/578 (0%)		1/609 (0.2%)
Hypercalcaemia	0/578 (0%)		1/609 (0.2%)
Hyperglycaemia	0/578 (0%)		3/609 (0.5%)
Hypoglycaemia	1/578 (0.2%)		0/609 (0%)
Hypokalaemia	1/578 (0.2%)		0/609 (0%)
Hyponatraemia	1/578 (0.2%)		1/609 (0.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/578 (0%)		2/609 (0.3%)
Back pain	2/578 (0.3%)		3/609 (0.5%)
Bone pain	0/578 (0%)		4/609 (0.7%)
Musculoskeletal chest pain	0/578 (0%)		2/609 (0.3%)
Musculoskeletal pain	1/578 (0.2%)		1/609 (0.2%)
Myalgia	1/578 (0.2%)		0/609 (0%)
Neck pain	0/578 (0%)		1/609 (0.2%)
Pain in extremity	0/578 (0%)		1/609 (0.2%)
Rhabdomyolysis	0/578 (0%)		1/609 (0.2%)
Muscular weakness	0/578 (0%)		1/609 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	1/578 (0.2%)		0/609 (0%)
Colon cancer	1/578 (0.2%)		0/609 (0%)
Neoplasm malignant	0/578 (0%)		1/609 (0.2%)
Prostate cancer	0/578 (0%)		1/609 (0.2%)
Basal cell carcinoma	0/578 (0%)		1/609 (0.2%)
Nervous system disorders
Aphasia	0/578 (0%)		1/609 (0.2%)
Cerebral artery embolism	0/578 (0%)		1/609 (0.2%)
Cerebral thrombosis	1/578 (0.2%)		0/609 (0%)
Cerebrovascular accident	0/578 (0%)		2/609 (0.3%)
Cognitive disorder	0/578 (0%)		1/609 (0.2%)
Depressed level of consciousness	0/578 (0%)		1/609 (0.2%)
Dizziness	1/578 (0.2%)		1/609 (0.2%)
Encephalopathy	0/578 (0%)		1/609 (0.2%)
Generalised tonic-clonic seizure	0/578 (0%)		1/609 (0.2%)
Guillain-Barre syndrome	0/578 (0%)		2/609 (0.3%)
Hemiparesis	0/578 (0%)		1/609 (0.2%)
Leukoencephalopathy	0/578 (0%)		1/609 (0.2%)
Neuralgia	0/578 (0%)		1/609 (0.2%)
Peripheral sensory neuropathy	0/578 (0%)		1/609 (0.2%)
Sciatica	1/578 (0.2%)		0/609 (0%)
Seizure	1/578 (0.2%)		3/609 (0.5%)
Syncope	3/578 (0.5%)		1/609 (0.2%)
Haemorrhage intracranial	0/578 (0%)		1/609 (0.2%)
Psychiatric disorders
Confusional state	2/578 (0.3%)		1/609 (0.2%)
Mental status change	0/578 (0%)		1/609 (0.2%)
Renal and urinary disorders
Acute kidney injury	4/578 (0.7%)		1/609 (0.2%)
Haematuria	0/578 (0%)		1/609 (0.2%)
Henoch-Schonlein purpura nephritis	0/578 (0%)		1/609 (0.2%)
Renal failure	0/578 (0%)		1/609 (0.2%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/578 (0%)		1/609 (0.2%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	0/578 (0%)		1/609 (0.2%)
Acute respiratory failure	0/578 (0%)		1/609 (0.2%)
Aspiration	0/578 (0%)		1/609 (0.2%)
Atelectasis	0/578 (0%)		1/609 (0.2%)
Bronchial obstruction	1/578 (0.2%)		0/609 (0%)
Bronchospasm	0/578 (0%)		1/609 (0.2%)
Chronic obstructive pulmonary disease	3/578 (0.5%)		2/609 (0.3%)
Cough	0/578 (0%)		1/609 (0.2%)
Dyspnoea	7/578 (1.2%)		13/609 (2.1%)
Emphysema	0/578 (0%)		1/609 (0.2%)
Haemoptysis	5/578 (0.9%)		6/609 (1%)
Hypoxia	1/578 (0.2%)		3/609 (0.5%)
Interstitial lung disease	0/578 (0%)		1/609 (0.2%)
Organising pneumonia	0/578 (0%)		1/609 (0.2%)
Pleural effusion	5/578 (0.9%)		11/609 (1.8%)
Pleural fistula	0/578 (0%)		1/609 (0.2%)
Pleuritic pain	0/578 (0%)		1/609 (0.2%)
Pneumonia aspiration	0/578 (0%)		2/609 (0.3%)
Pneumonitis	1/578 (0.2%)		6/609 (1%)
Pneumothorax	2/578 (0.3%)		3/609 (0.5%)
Pneumothorax spontaneous	1/578 (0.2%)		0/609 (0%)
Pulmonary embolism	2/578 (0.3%)		9/609 (1.5%)
Pulmonary haemorrhage	2/578 (0.3%)		1/609 (0.2%)
Pulmonary oedema	1/578 (0.2%)		1/609 (0.2%)
Respiratory distress	1/578 (0.2%)		0/609 (0%)
Respiratory failure	2/578 (0.3%)		3/609 (0.5%)
Tachypnoea	0/578 (0%)		1/609 (0.2%)
Skin and subcutaneous tissue disorders
Pemphigoid	0/578 (0%)		1/609 (0.2%)
Pruritus	0/578 (0%)		1/609 (0.2%)
Pruritus generalised	0/578 (0%)		1/609 (0.2%)
Vascular disorders
Deep vein thrombosis	2/578 (0.3%)		1/609 (0.2%)
Haematoma	1/578 (0.2%)		0/609 (0%)
Hypotension	1/578 (0.2%)		3/609 (0.5%)
Superior vena cava syndrome	1/578 (0.2%)		3/609 (0.5%)
Thrombosis	0/578 (0%)		1/609 (0.2%)
Other (Not Including Serious) Adverse Events
	Docetaxel		Atezolizumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	535/578 (92.6%)		541/609 (88.8%)
Blood and lymphatic system disorders
Anaemia	130/578 (22.5%)		71/609 (11.7%)
Neutropenia	88/578 (15.2%)		12/609 (2%)
Eye disorders
Lacrimation increased	33/578 (5.7%)		6/609 (1%)
Gastrointestinal disorders
Abdominal pain	33/578 (5.7%)		23/609 (3.8%)
Constipation	82/578 (14.2%)		111/609 (18.2%)
Diarrhoea	138/578 (23.9%)		100/609 (16.4%)
Nausea	131/578 (22.7%)		110/609 (18.1%)
Stomatitis	62/578 (10.7%)		21/609 (3.4%)
Vomiting	61/578 (10.6%)		75/609 (12.3%)
General disorders
Asthenia	113/578 (19.6%)		117/609 (19.2%)
Chest pain	25/578 (4.3%)		55/609 (9%)
Fatigue	206/578 (35.6%)		165/609 (27.1%)
Influenza like illness	14/578 (2.4%)		35/609 (5.7%)
Malaise	29/578 (5%)		15/609 (2.5%)
Mucosal inflammation	41/578 (7.1%)		9/609 (1.5%)
Oedema peripheral	82/578 (14.2%)		55/609 (9%)
Pyrexia	70/578 (12.1%)		108/609 (17.7%)
Infections and infestations
Nasopharyngitis	21/578 (3.6%)		39/609 (6.4%)
Upper respiratory tract infection	15/578 (2.6%)		41/609 (6.7%)
Urinary tract infection	30/578 (5.2%)		22/609 (3.6%)
Bronchitis	24/578 (4.2%)		34/609 (5.6%)
Investigations
Alanine aminotransferase increased	14/578 (2.4%)		36/609 (5.9%)
Aspartate aminotransferase increased	12/578 (2.1%)		42/609 (6.9%)
Neutrophil count decreased	50/578 (8.7%)		3/609 (0.5%)
Weight decreased	30/578 (5.2%)		56/609 (9.2%)
Metabolism and nutrition disorders
Decreased appetite	135/578 (23.4%)		150/609 (24.6%)
Musculoskeletal and connective tissue disorders
Arthralgia	59/578 (10.2%)		80/609 (13.1%)
Back pain	41/578 (7.1%)		70/609 (11.5%)
Musculoskeletal pain	24/578 (4.2%)		69/609 (11.3%)
Myalgia	90/578 (15.6%)		44/609 (7.2%)
Pain in extremity	38/578 (6.6%)		56/609 (9.2%)
Musculoskeletal chest pain	7/578 (1.2%)		33/609 (5.4%)
Nervous system disorders
Dizziness	32/578 (5.5%)		48/609 (7.9%)
Dysgeusia	48/578 (8.3%)		18/609 (3%)
Headache	46/578 (8%)		62/609 (10.2%)
Neuropathy peripheral	65/578 (11.2%)		27/609 (4.4%)
Paraesthesia	45/578 (7.8%)		23/609 (3.8%)
Peripheral sensory neuropathy	43/578 (7.4%)		5/609 (0.8%)
Psychiatric disorders
Depression	6/578 (1%)		31/609 (5.1%)
Insomnia	43/578 (7.4%)		56/609 (9.2%)
Respiratory, thoracic and mediastinal disorders
Cough	107/578 (18.5%)		146/609 (24%)
Dyspnoea	108/578 (18.7%)		117/609 (19.2%)
Haemoptysis	28/578 (4.8%)		40/609 (6.6%)
Productive cough	21/578 (3.6%)		36/609 (5.9%)
Skin and subcutaneous tissue disorders
Alopecia	205/578 (35.5%)		5/609 (0.8%)
Dry skin	34/578 (5.9%)		30/609 (4.9%)
Nail disorder	30/578 (5.2%)		1/609 (0.2%)
Pruritus	18/578 (3.1%)		57/609 (9.4%)
Rash	51/578 (8.8%)		65/609 (10.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.