A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00556712
Collaborator
(none)
889
133
2
58
6.7
0.1
Study Details
Study Description
Brief Summary
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
889 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind Study to Evaluate the Effect of Tarceva or Placebo Following Platinum-based CT on Overall Survival and Disease Progression in Patients With Advanced, Recurrent or Metastatic NSCLS Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy
Study Start Date
:
Jan 1, 2006
Actual Primary Completion Date
:
Nov 1, 2010
Actual Study Completion Date
:
Nov 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Erlotinib Participants received erlotinib, 150 milligrams (mg), orally (PO), daily from randomization until progressive disease (PD), death, or unacceptable toxicity. |
Drug: erlotinib [Tarceva]
150mg po daily
|
| Placebo Comparator: Placebo Participants received a placebo, PO, daily, from randomization until PD, death, or unacceptable toxicity. |
Drug: Placebo
po daily
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) [Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
- PFS in All Participants (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.
- Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) [6 months]
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
- Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
- PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) [Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
- Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) [6 months]
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Secondary Outcome Measures
- Percentage of All Participants Who Died (Data Cutoff 12 January 2012) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).]
- Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) [Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)]
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
- Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) [1 year]
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
- Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)]
- OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)]
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
- Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) [1 year]
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
- Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)]
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
- PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
- Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) [6 months]
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
- Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
- OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
- Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008) [1 year]
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
- Time to Progression (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.
- Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008) [6 months]
TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.
- Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
- Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
- Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
- Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
- Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
- Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline.
- Time to Symptom Progression (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology.
- Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008) [6 months]
LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology.
- Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment.
- Time to Deterioration in TOI (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.
- Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008) [6 months]
TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology.
- Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L.
- Time to Deterioration in QoL (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.
- Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008) [6 months]
Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology.
- Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.
- Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) [Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)]
Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
adult patients >=18 years of age;
-
histologically documented, locally advanced , recurrent or metastatic NSCLC;
-
measurable disease;
-
no disease progression after 4 cycles of platinum-based chemotherapy.
Exclusion Criteria:
-
unstable systemic disease;
-
any other malignancies in the last 5 years.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Leonards | New South Wales | Australia | 2065 | |
| 2 | Waratah | New South Wales | Australia | 2298 | |
| 3 | Brisbane | Queensland | Australia | 4101 | |
| 4 | Adelaide | South Australia | Australia | 5041 | |
| 5 | East Bentleigh | Victoria | Australia | VIC 3165 | |
| 6 | Fitzroy | Victoria | Australia | 3065 | |
| 7 | Geelong | Victoria | Australia | 3220 | |
| 8 | Melbourne | Victoria | Australia | 3084 | |
| 9 | Innsbruck | Austria | 6020 | ||
| 10 | Klagenfurt | Austria | 9010 | ||
| 11 | Wien | Austria | 1140 | ||
| 12 | Wien | Austria | 1145 | ||
| 13 | Antwerpen | Belgium | 2020 | ||
| 14 | Edegem | Belgium | 2650 | ||
| 15 | Winnipeg | Manitoba | Canada | R3E 0V9 | |
| 16 | Oshawa | Ontario | Canada | L1G 2B9 | |
| 17 | Sault Ste Marie | Ontario | Canada | P6A 2C4 | |
| 18 | Toronto | Ontario | Canada | M4C 3E7 | |
| 19 | Laval | Quebec | Canada | H7M 3L9 | |
| 20 | Montreal | Quebec | Canada | H4J 1C5 | |
| 21 | Santiago | Chile | 0000 | ||
| 22 | Beijing | China | 100730 | ||
| 23 | Guangzhou | China | 510060 | ||
| 24 | Guangzhou | China | 510080 | ||
| 25 | Shanghai | China | 200032 | ||
| 26 | Ceské Budejovice | Czech Republic | 370 87 | ||
| 27 | Olomouc | Czech Republic | 775 20 | ||
| 28 | Plzen | Czech Republic | 305 99 | ||
| 29 | Herlev | Denmark | 2730 | ||
| 30 | Odense | Denmark | 5000 | ||
| 31 | Bayonne | France | 64100 | ||
| 32 | Brest | France | 29200 | ||
| 33 | Clermont-ferrand | France | 63003 | ||
| 34 | Dijon | France | 21079 | ||
| 35 | Le Mans | France | 72037 | ||
| 36 | Lille | France | 59020 | ||
| 37 | Limoges | France | 87042 | ||
| 38 | Paris | France | 75674 | ||
| 39 | Paris | France | 75908 | ||
| 40 | PAU | France | 64046 | ||
| 41 | Toulouse | France | 31400 | ||
| 42 | Vandoeuvre-les-nancy | France | 54511 | ||
| 43 | Bad Berka | Germany | 99437 | ||
| 44 | Bochum | Germany | 44791 | ||
| 45 | Halle (Saale) | Germany | 06120 | ||
| 46 | Herne | Germany | 44625 | ||
| 47 | Neuruppin | Germany | 16816 | ||
| 48 | Villingen-Schwenningen | Germany | 78052 | ||
| 49 | Athens | Greece | 11527 | ||
| 50 | Athens | Greece | 14564 | ||
| 51 | Heraklion | Greece | 71110 | ||
| 52 | Budapest | Hungary | 1122 | ||
| 53 | Budapest | Hungary | 1125 | ||
| 54 | Budapest | Hungary | 1529 | ||
| 55 | Deszk | Hungary | 6772 | ||
| 56 | Nyíregyháza | Hungary | 4400 | ||
| 57 | Pecs | Hungary | 7635 | ||
| 58 | Szombathely | Hungary | 9700 | ||
| 59 | Torokbalint | Hungary | 2045 | ||
| 60 | Bologna | Emilia-Romagna | Italy | 40139 | |
| 61 | Roma | Lazio | Italy | 00168 | |
| 62 | Ancona | Marche | Italy | ||
| 63 | Daegu | Korea, Republic of | 700-712 | ||
| 64 | Seoul | Korea, Republic of | 110-744 | ||
| 65 | Seoul | Korea, Republic of | 120-752 | ||
| 66 | Seoul | Korea, Republic of | 135-710 | ||
| 67 | Seoul | Korea, Republic of | 138-736 | ||
| 68 | Seoul | Korea, Republic of | 139-709 | ||
| 69 | Suwon | Korea, Republic of | |||
| 70 | Kaunas | Lithuania | |||
| 71 | Klaipeda | Lithuania | 92288 | ||
| 72 | Vilnius | Lithuania | 08660 | ||
| 73 | Kuala Lumpur | Malaysia | 59100 | ||
| 74 | Penang | Malaysia | 11200 | ||
| 75 | Amsterdam | Netherlands | 1081 HV | ||
| 76 | Heerlen | Netherlands | 6419 PC | ||
| 77 | Nieuwegein | Netherlands | 3435 CM | ||
| 78 | Vlissingen | Netherlands | 4382 EE | ||
| 79 | Auckland | New Zealand | 1009 | ||
| 80 | Christchurch | New Zealand | |||
| 81 | Lodz | Poland | 91-520 | ||
| 82 | Lodz | Poland | 94-306 | ||
| 83 | Otwock | Poland | 05-400 | ||
| 84 | Bucuresti | Romania | 022328 | ||
| 85 | Cluj Napoca | Romania | 400015 | ||
| 86 | Iasi | Romania | 6600 | ||
| 87 | Timisoara | Romania | 1900 | ||
| 88 | Arkhangelsk | Russian Federation | 163045 | ||
| 89 | Balashikha | Russian Federation | 143900 | ||
| 90 | Chelyabinsk | Russian Federation | 454 087 | ||
| 91 | Kazan | Russian Federation | 420029 | ||
| 92 | Kazan | Russian Federation | 420111 | ||
| 93 | Kirov | Russian Federation | |||
| 94 | Krasnodar | Russian Federation | 350040 | ||
| 95 | Krasnodar | Russian Federation | |||
| 96 | Kuzmolovo | Russian Federation | 188663 | ||
| 97 | Moscow | Russian Federation | 105203 | ||
| 98 | Moscow | Russian Federation | 105229 | ||
| 99 | Moscow | Russian Federation | 115478 | ||
| 100 | Moscow | Russian Federation | 117837 | ||
| 101 | Moscow | Russian Federation | 125284 | ||
| 102 | Nizhny Novgorod | Russian Federation | 603000 | ||
| 103 | Perm | Russian Federation | 614 066 | ||
| 104 | Smolensk | Russian Federation | |||
| 105 | Soshi | Russian Federation | 354057 | ||
| 106 | St Petersburg | Russian Federation | 191015 | ||
| 107 | St Petersburg | Russian Federation | 195067 | ||
| 108 | St Petersburg | Russian Federation | 197022 | ||
| 109 | St Petersburg | Russian Federation | |||
| 110 | Yaroslavl | Russian Federation | 150054 | ||
| 111 | Banska Bystrica | Slovakia | 975 17 | ||
| 112 | Bratislava | Slovakia | 825 56 | ||
| 113 | Nitra | Slovakia | 949 88 | ||
| 114 | Poprad | Slovakia | 058 87 | ||
| 115 | Golnik | Slovenia | |||
| 116 | Ljubljana | Slovenia | 1000 | ||
| 117 | Maribor | Slovenia | |||
| 118 | Durban | South Africa | 4091 | ||
| 119 | Johannesburg | South Africa | 2196 | ||
| 120 | Pretoria | South Africa | 0001 | ||
| 121 | Oviedo | Asturias | Spain | 33006 | |
| 122 | Santander | Cantabria | Spain | 39008 | |
| 123 | La Coruña | Spain | 15006 | ||
| 124 | Valencia | Spain | 46026 | ||
| 125 | Zaragoza | Spain | 50009 | ||
| 126 | Kharkov | Ukraine | 61024 | ||
| 127 | Uzhgorod | Ukraine | 88000 | ||
| 128 | Zaporozhye | Ukraine | 69104 | ||
| 129 | Chelmsford | United Kingdom | CM1 7ET | ||
| 130 | Dundee | United Kingdom | DD1 9SY | ||
| 131 | Leicester | United Kingdom | LE1 5WW | ||
| 132 | Plymouth | United Kingdom | PL6 8DH | ||
| 133 | Caracas | Venezuela | 1062 |
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:
NCT00556712
Other Study ID Numbers:
- BO18192
First Posted:
Nov 12, 2007
Last Update Posted:
Feb 11, 2015
Last Verified:
Jan 1, 2015
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Erlotinib, 150 Milligrams Per Day (mg/Day) |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Period Title: Overall Study | ||
| STARTED | 451 | 438 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 451 | 438 |
Baseline Characteristics
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day | Total |
|---|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Total of all reporting groups |
| Overall Participants | 451 | 438 | 889 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
59.7
(9.39)
|
59.8
(9.52)
|
59.8
(9.44)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
113
25.1%
|
117
26.7%
|
230
25.9%
|
| Male |
338
74.9%
|
321
73.3%
|
659
74.1%
|
Outcome Measures
| Title | Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) |
|---|---|
| Description | Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Time Frame | Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; participants with PD prior to randomization were excluded from analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 447 | 437 |
| Number [percentage of participants] |
89.5
19.8%
|
79.9
18.2%
|
| Title | PFS in All Participants (Data Cutoff 17 May 2008) |
|---|---|
| Description | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; participants with PD prior to randomization were excluded from analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 447 | 437 |
| Median (95% Confidence Interval) [weeks] |
11.1
|
12.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.71 | |
| Confidence Interval |
(2-Sided) 95% 0.62 to 0.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) |
|---|---|
| Description | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; participants with PD prior to randomization were excluded from analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 447 | 437 |
| Number (95% Confidence Interval) [percentage of participants] |
15.0
3.3%
|
25.0
5.7%
|
| Title | Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) |
|---|---|
| Description | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC positive tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 311 | 307 |
| Number [percentage of participants] |
89.4
19.8%
|
79.5
18.2%
|
| Title | Percentage of All Participants Who Died (Data Cutoff 12 January 2012) |
|---|---|
| Description | |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 451 | 438 |
| Number [percentage of participants] |
87.1
19.3%
|
82.0
18.7%
|
| Title | Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) |
|---|---|
| Description | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 451 | 438 |
| Median (95% Confidence Interval) [months] |
11.0
|
12.4
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0097 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.72 to 0.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) |
|---|---|
| Description | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 451 | 438 |
| Number (95% Confidence Interval) [percentage of participants] |
45.0
10%
|
50.0
11.4%
|
| Title | Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) |
|---|---|
| Description | |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC positive tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 313 | 308 |
| Number [percentage of participants] |
87.5
19.4%
|
80.5
18.4%
|
| Title | OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) |
|---|---|
| Description | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC positive tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 313 | 308 |
| Median (95% Confidence Interval) [months] |
11.0
|
12.8
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0050 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 95% 0.66 to 0.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) |
|---|---|
| Description | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 313 | 308 |
| Number (95% Confidence Interval) [percentage of participants] |
47.0
10.4%
|
52.0
11.9%
|
| Title | Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008) |
|---|---|
| Description | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC negative tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 59 | 62 |
| Number [percentage of participants] |
89.8
19.9%
|
77.4
17.7%
|
| Title | PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) |
|---|---|
| Description | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC negative tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 59 | 62 |
| Median (95% Confidence Interval) [weeks] |
9.0
|
11.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1768 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.77 | |
| Confidence Interval |
(2-Sided) 95% 0.51 to 1.14 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) |
|---|---|
| Description | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC negative tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 59 | 62 |
| Number (95% Confidence Interval) [percentage of participants] |
11.0
2.4%
|
22.0
5%
|
| Title | Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008) |
|---|---|
| Description | |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC negative tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 59 | 62 |
| Number [percentage of participants] |
50.8
11.3%
|
41.9
9.6%
|
| Title | OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) |
|---|---|
| Description | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC negative tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 59 | 62 |
| Median (95% Confidence Interval) [months] |
10.2
|
8.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4797 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.49 to 1.40 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008) |
|---|---|
| Description | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC negative tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 59 | 62 |
| Number (95% Confidence Interval) [percentage of participants] |
20.0
4.4%
|
42.0
9.6%
|
| Title | Time to Progression (Data Cutoff 17 May 2008) |
|---|---|
| Description | The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; participants with PD prior to randomization were excluded from analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 447 | 437 |
| Median (95% Confidence Interval) [weeks] |
11.3
|
12.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.70 | |
| Confidence Interval |
(2-Sided) 95% 0.61 to 0.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008) |
|---|---|
| Description | TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; participants with PD prior to randomization were excluded from analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 447 | 437 |
| Number (95% Confidence Interval) [percentage of participants] |
15.0
3.3%
|
26.0
5.9%
|
| Title | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008) |
|---|---|
| Description | BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 445 | 436 |
| Number (95% Confidence Interval) [percentage of participants] |
5.4
1.2%
|
11.9
2.7%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0006 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Rates |
| Estimated Value | 6.53 | |
| Confidence Interval |
(2-Sided) 95% 2.7 to 10.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method. | |
| Title | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) |
|---|---|
| Description | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis; and 7 and 17 participants were not assessed from the Placebo and Erlotinib, 150 mg/day groups, respectively. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 445 | 436 |
| CR |
0.7
0.2%
|
0.9
0.2%
|
| PR |
4.7
1%
|
11.0
2.5%
|
| SD |
45.4
10.1%
|
48.6
11.1%
|
| PD |
47.6
10.6%
|
35.6
8.1%
|
| Title | Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008) |
|---|---|
| Description | Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 445 | 436 |
| Number (95% Confidence Interval) [percentage of participants] |
1.3
0.3%
|
5.5
1.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0007 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Response Upgrade Rates |
| Estimated Value | 4.2 | |
| Confidence Interval |
(2-Sided) 95% 1.6 to 6.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method. | |
| Title | Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) |
|---|---|
| Description | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 445 | 436 |
| PR to CR |
0.4
0.1%
|
0.5
0.1%
|
| SD to PR |
0.9
0.2%
|
4.8
1.1%
|
| SD to CR |
0.0
0%
|
0.2
0%
|
| Title | Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) |
|---|---|
| Description | Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 445 | 436 |
| CR Plus (+) PR + SD |
50.8
11.3%
|
60.6
13.8%
|
| CR + PR + SD >12 Weeks |
27.4
6.1%
|
40.8
9.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | Analysis included CR + PR + SD rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0035 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Disease Control Rates |
| Estimated Value | 9.8 | |
| Confidence Interval |
(2-Sided) 95% 3.1 to 16.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | Analysis included CR + PR + SD > 12 weeks rate. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.0001 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in Disease Control Rates |
| Estimated Value | 13.4 | |
| Confidence Interval |
(2-Sided) 95% 7.1 to 19.7 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Approximate 95% CI for the difference of two rates was determined using the Hauck-Anderson method. | |
| Title | Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008) |
|---|---|
| Description | LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; 56 and 48 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 395 | 390 |
| Number [percentage of participants] |
44.1
9.8%
|
47.7
10.9%
|
| Title | Time to Symptom Progression (Data Cutoff 17 May 2008) |
|---|---|
| Description | The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 395 | 390 |
| Median (95% Confidence Interval) [weeks] |
17.6
|
18.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3787 |
| 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 | ||
| Title | Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008) |
|---|---|
| Description | LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 395 | 390 |
| Number (95% Confidence Interval) [percentage of participants] |
35.0
7.8%
|
41.0
9.4%
|
| Title | PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) |
|---|---|
| Description | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS;only participants with EGFR IHC positive tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 311 | 307 |
| Median (95% Confidence Interval) [weeks] |
11.1
|
12.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.0001 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.69 | |
| Confidence Interval |
(2-Sided) 95% 0.58 to 0.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) |
|---|---|
| Description | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; only participants with EGFR IHC positive tumors were included in the analysis. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 311 | 307 |
| Number (95% Confidence Interval) [percentage of participants] |
16.0
3.5%
|
27.0
6.2%
|
| Title | Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008) |
|---|---|
| Description | The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; 59 and 49 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 392 | 389 |
| Number [percentage of participants] |
43.1
9.6%
|
50.9
11.6%
|
| Title | Time to Deterioration in TOI (Data Cutoff 17 May 2008) |
|---|---|
| Description | The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 392 | 389 |
| Median (95% Confidence Interval) [weeks] |
18.9
|
18.1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5385 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.06 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 1.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008) |
|---|---|
| Description | TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 392 | 389 |
| Number (95% Confidence Interval) [percentage of participants] |
41.0
9.1%
|
39.0
8.9%
|
| Title | Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008) |
|---|---|
| Description | Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; 62 and 51 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively, |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 389 | 387 |
| Number [percentage of participants] |
51.7
11.5%
|
55.3
12.6%
|
| Title | Time to Deterioration in QoL (Data Cutoff 17 May 2008) |
|---|---|
| Description | The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 389 | 387 |
| Median (95% Confidence Interval) [weeks] |
12.3
|
12.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Erlotinib, 150 mg/Day |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6530 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.96 | |
| Confidence Interval |
(2-Sided) 95% 0.79 to 1.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008) |
|---|---|
| Description | Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 389 | 387 |
| Number (95% Confidence Interval) [percentage of participants] |
34.0
7.5%
|
32.0
7.3%
|
| Title | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) |
|---|---|
| Description | Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; n=number of participants assessed for the given parameter at the specified timepoint. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 397 | 392 |
| BL: Physical Well-Being (n=397,392) |
20.85
(4.817)
|
20.96
(4.781)
|
| BL: Social Well-Being (n=397,392) |
20.84
(5.496)
|
20.98
(5.285)
|
| BL: Emotional Well-Being (n=397,393) |
16.92
(4.534)
|
16.77
(4.862)
|
| BL: Functional Well-Being (n=397,393) |
16.15
(5.488)
|
16.84
(5.514)
|
| BL: FACT-L Subscale Score (n=397,391) |
24.17
(4.892)
|
24.46
(4.697)
|
| BL: Lung Cancer Subscale Score (n=397,391) |
19.82
(4.188)
|
20.07
(4.240)
|
| BL: Total FACT-General (FACT-G) Score (n=396,391) |
74.68
(14.787)
|
75.52
(14.612)
|
| BL: Trial Outcome Index (n=396,390) |
56.83
(11.830)
|
57.90
(11.682)
|
| BL: Total FACT-L Score (n=395,389) |
98.85
(18.007)
|
100.02
(17.751)
|
| Week 6: Physical Well-Being (n=274,304) |
21.44
(5.117)
|
20.69
(5.180)
|
| Week 6: Social Well-Being (n=274,303 |
20.62
(5.437)
|
21.43
(5.178)
|
| Week 6: Emotional Well-Being (n=275,302) |
16.53
(4.587)
|
17.17
(4.748)
|
| Week 6: Functional Well-Being (n=275,302) |
16.41
(5.234)
|
16.87
(5.614)
|
| Week 6: FACT-L Subscale Score (n=275,300) |
24.45
(5.231)
|
24.80
(5.000)
|
| Week 6: Lung Cancer Subscale Score (n=275,300) |
19.78
(4.463)
|
20.13
(4.336)
|
| Week 6: Total FACT-G Score (n=274,300) |
74.82
(14.380)
|
76.14
(15.132)
|
| Week 6: Trial Outcome Index (n=274,299) |
57.59
(12.292)
|
57.64
(12.482)
|
| Week 6: Total FACT-L Score (n=274,297) |
99.27
(17.857)
|
100.95
(18.360)
|
| Week 12: Physical Well-Being (n=144,194) |
21.93
(4.734)
|
20.78
(5.368)
|
| Week 12: Social Well-Being (n=143,194) |
20.38
(5.637)
|
20.04
(5.691)
|
| Week 12: Emotional Well-Being (n=144,194) |
17.21
(4.376)
|
16.85
(4.521)
|
| Week 12: Functional Well-Being (n=144,196) |
17.04
(5.770)
|
16.35
(5.745)
|
| Week 12: FACT-L Subscale Score (n=144,196) |
25.15
(4.735)
|
24.19
(5.323)
|
| Week 12: Lung Cancer Subscale Score (n=144,196) |
20.22
(4.015)
|
19.50
(4.600)
|
| Week 12: Total FACT-G Score (n=144,192) |
76.42
(14.889)
|
74.06
(15.754)
|
| Week 12: Trial Outcome Index (n=144,194) |
59.19
(12.129)
|
56.57
(13.276)
|
| Week 12: Total FACT-L Score (n=144,192) |
101.56
(17.824)
|
98.30
(19.337)
|
| Week 18: Physical Well-Being (n=86,143) |
21.60
(4.883)
|
21.40
(4.945)
|
| Week 18: Social Well-Being (n=86,143) |
21.08
(5.328)
|
19.94
(6.130)
|
| Week 18: Emotional Well-Being (n=86,143) |
17.33
(4.717)
|
17.14
(4.356)
|
| Week 18: Functional Well-Being (n=86,143) |
16.89
(5.289)
|
16.83
(5.553)
|
| Week 18: FACT-L Subscale Score (n=86,143) |
25.44
(4.645)
|
24.52
(5.344)
|
| Week 18: Lung Cancer Subscale Score (n=86,143) |
20.28
(4.003)
|
19.64
(4.635)
|
| Week 18: Total FACT-G Score (n=86,143) |
76.89
(14.385)
|
75.31
(16.648)
|
| Week 18: Trial Outcome Index (n=86,143) |
58.76
(11.492)
|
57.87
(12.803)
|
| Week 18: Total FACT-L Score (n=86,143) |
102.33
(17.502)
|
99.83
(20.558)
|
| Week 24: Physical Well-Being (n=59,101) |
21.78
(4.665)
|
21.21
(4.898)
|
| Week 24: Social Well-Being (n=59,101) |
20.79
(5.641)
|
20.49
(5.251)
|
| Week 24: Emotional Well-Being (n=59,100) |
16.86
(4.880)
|
16.54
(4.615)
|
| Week 24: Functional Well-Being (n=59,100) |
17.14
(6.062)
|
17.23
(5.300)
|
| Week 24: FACT-L Subscale Score (n=59,101) |
25.18
(5.126)
|
25.13
(5.245)
|
| Week 24: Lung Cancer Subscale Score (n=59,101) |
20.07
(4.246)
|
19.94
(4.487)
|
| Week 24: Total FACT-G Score (n=59,99) |
76.58
(16.091)
|
75.50
(15.754)
|
| Week 24: Trial Outcome Index (n=59,100) |
58.99
(11.837)
|
58.37
(12.686)
|
| Week 24: Total FACT-L Score (n=59,99) |
101.75
(19.347)
|
100.69
(19.831)
|
| Week 30: Physical Well-Being (n=37,66) |
21.74
(4.153)
|
21.77
(4.576)
|
| Week 30: Social Well-Being (n=37,66) |
20.50
(5.180)
|
20.74
(5.491)
|
| Week 30: Emotional Well-Being (n=37,66) |
16.37
(4.164)
|
17.23
(4.675)
|
| Week 30: Functional Well-Being (n=37,66) |
17.92
(5.082)
|
17.93
(5.510)
|
| Week 30: FACT-L Subscale Score (n=37,66) |
25.90
(3.484)
|
25.86
(4.817)
|
| Week 30: Lung Cancer Subscale Score (n=37,66) |
20.66
(3.073)
|
20.61
(4.393)
|
| Week 30: Total FACT-G Score (n=37,66) |
76.54
(11.915)
|
77.66
(15.078)
|
| Week 30: Trial Outcome Index (n=37,66) |
60.32
(9.753)
|
60.30
(11.876)
|
| Week 30: Total FACT-L Score (n=37,66) |
102.44
(14.063)
|
103.52
(18.367)
|
| Week 36: Physical Well-Being (n=25,47) |
21.60
(3.317)
|
22.26
(4.480)
|
| Week 36: Social Well-Being (n=25,47) |
20.02
(5.769)
|
20.15
(4.988)
|
| Week 36: Emotional Well-Being (n=25,47) |
17.31
(3.736)
|
17.54
(4.540)
|
| Week 36: Fuctional Well-Being (n=25,47) |
16.06
(4.287)
|
18.06
(5.720)
|
| Week 36: FACT-L Subscale Score (n=25,47) |
24.48
(4.089)
|
25.83
(5.305)
|
| Week 36: Lung Cancer Subscale Score (n=25,47) |
19.36
(3.893)
|
20.55
(4.463)
|
| Week 36: Total FACT-G Score (n=25,47) |
74.99
(11.066)
|
78.02
(15.688)
|
| Week 36: Trial Outcome Index (n=25,47) |
57.02
(9.426)
|
60.87
(11.963)
|
| Week 36: Total FACT-L Score (n=25,47) |
99.27
(13.672)
|
103.86
(19.244)
|
| Week 42: Physical Well-Being (n=19,35) |
21.76
(3.592)
|
22.19
(5.035)
|
| Week 42: Social Well-Being (n=19,35) |
18.45
(6.262)
|
20.40
(5.234)
|
| Week 42: Emotional Well-Being (n=19,35) |
16.95
(4.089)
|
17.43
(4.984)
|
| Week 42: Functional Well-Being (n=19,35) |
15.32
(3.902)
|
18.57
(5.500)
|
| Week 42: FACT-L Subscale Score (n=19,35) |
24.63
(4.448)
|
26.67
(5.357)
|
| Week 42: Lung Cancer Subscale Score (n=19,35) |
19.50
(4.092)
|
21.21
(4.607)
|
| Week 42: FACT-G Score (n=19,35) |
72.74
(12.406)
|
78.59
(16.316)
|
| Week 42: Trial Outcome Index (n=19,35) |
56.58
(9.562)
|
61.97
(12.622)
|
| Week 42: FACT-L Score (n=19,35) |
97.11
(14.951)
|
105.25
(20.385)
|
| Week 48: Physical Well-Being (n=13,29) |
21.38
(4.154)
|
23.23
(4.016)
|
| Week 48: Social Well-Being (n=13,29) |
17.23
(7.567)
|
20.24
(5.569)
|
| Week 48: Emotional Well-Being (n=13,29) |
18.69
(3.011)
|
17.59
(4.903)
|
| Week 48: Functional Well-Being (n=13,29) |
14.15
(2.672)
|
18.48
(4.501)
|
| Week 48: FACT-L Subscale Score (n=12,29) |
23.35
(3.647)
|
26.80
(5.591)
|
| Week 48: Lung Cancer Subscale Score (n=12,29) |
18.75
(3.646)
|
21.21
(4.967)
|
| Week 48: FACT-G Score (n=12,29) |
71.46
(12.069)
|
79.53
(14.672)
|
| Week 48: Trial Outcome Index (n=12,29) |
54.58
(9.140)
|
62.92
(11.105)
|
| Week 48: FACT-L Score (n=12,29) |
96.19
(14.394)
|
106.33
(18.701)
|
| Week 60: Physical Well-Being (n=9,17) |
22.67
(4.664)
|
23.65
(4.212)
|
| Week 60: Social Well-Being (n=9,17) |
17.78
(6.405)
|
21.31
(6.530)
|
| Week 60: Emotional Well-Being (n=9,17) |
16.78
(3.232)
|
19.12
(3.638)
|
| Week 60: Functional Well-Being (n=9,17) |
15.11
(3.408)
|
18.65
(6.828)
|
| Week 60: FACT-L Subscale Score (n=9,17) |
23.43
(5.010)
|
25.99
(6.844)
|
| Week 60: Lung Cancer Subscale Score (n=9,17) |
17.89
(3.919)
|
20.47
(5.959)
|
| Week 60: Total FACT-G Score (n=9,17) |
72.34
(11.607)
|
82.73
(17.803)
|
| Week 60: Trial Outcome Index (n=9,17) |
55.67
(9.695)
|
62.76
(14.316)
|
| Week 60: Total FACT-L Score (n=9,17) |
95.77
(15.703)
|
108.71
(23.069)
|
| Week 72: Physical Well-Being (n=6,8) |
22.17
(4.997)
|
23.25
(4.097)
|
| Week 72: Social Well-Being (n=6,8) |
19.00
(7.251)
|
21.44
(5.852)
|
| Week 72: Emotional Well-Being (n=6,8) |
17.17
(2.401)
|
18.25
(5.007)
|
| Week 72: Functional Well-Being (n=6,8) |
15.22
(4.457)
|
16.50
(5.855)
|
| Week 72: FACT-L Subscale Score (n=6,8) |
21.23
(5.154)
|
26.48
(6.185)
|
| Week 72: Lung Cancer Subscale Score (n=6,8) |
17.17
(4.021)
|
21.40
(5.724)
|
| Week 72: Total FACT-G Score (n=6,8) |
73.67
(14.820)
|
79.44
(16.176)
|
| Week 72: Trial Outcome Index (n=6,8) |
54.67
(11.911)
|
61.15
(14.343)
|
| Week 72: Total FACT-L Score (n=6,8) |
94.90
(18.833)
|
105.92
(21.282)
|
| Week 84: Physical Well-Being (n=1,0) |
20.00
(NA)
|
NA
(NA)
|
| Week 84: Social Well-Being (n=1,0) |
14.00
(NA)
|
NA
(NA)
|
| Week 84: Emotional Well-Being (n=1,0) |
13.00
(NA)
|
NA
(NA)
|
| Week 84: Functional Well-Being (n=1,0) |
18.00
(NA)
|
NA
(NA)
|
| Week 84: FACT-L Subscale Score (n=1,0) |
17.00
(NA)
|
NA
(NA)
|
| Week 84: Lung Cancer Subscale Score (n=1,0) |
13.00
(NA)
|
NA
(NA)
|
| Week 84: Total FACT-G Score (n=1,0) |
65.00
(NA)
|
NA
(NA)
|
| Week 84: Trial Outcome Index (n=1,0) |
51.00
(NA)
|
NA
(NA)
|
| Week 84: Total FACT-L Score (n=1,0) |
82.00
(NA)
|
NA
(NA)
|
| Off Trtmt: Physical Well-Being (n=265,215) |
19.57
(5.668)
|
18.50
(5.534)
|
| Off Trtmt: Social Well-Being (n=263,216) |
20.01
(5.380)
|
20.68
(5.265)
|
| Off Trtmt: Emotional Well-Being (n=265,216) |
14.76
(5.157)
|
15.11
(5.183)
|
| Off Trtmt: Functional Well-Being (n=265,216) |
14.90
(5.893)
|
14.58
(5.934)
|
| Off Trtmt: FACT-L Subscale Score (n=264,214) |
22.80
(5.268)
|
22.88
(4.911)
|
| Off Trtmt: Lung Cancer Subscale Score (n=264,214) |
18.06
(4.629)
|
18.16
(4.383)
|
| Off Trtmt:Total FACT-G Score (n=261,214) |
69.29
(15.730)
|
68.94
(15.669)
|
| Off Trtmt:Trial Outcome Index (n=263,213) |
52.61
(13.475)
|
51.34
(12.974)
|
| Off Trtmt:Total FACT-L Score (n=260,212) |
92.14
(19.324)
|
91.89
(18.738)
|
| Title | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) |
|---|---|
| Description | Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL. |
| Time Frame | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS; n=number of participants assessed for the given parameter at the specified timepoint. |
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day |
|---|---|---|
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. |
| Measure Participants | 274 | 303 |
| Week 6: Physical Well-Being (n=274,303) |
0.22
(4.235)
|
-0.47
(4.729)
|
| Week 6: Social Well-Being (n=274,303) |
-0.24
(4.901)
|
0.23
(4.202)
|
| Week 6: Emotional Well-Being (n=274,302) |
-0.41
(3.801)
|
0.29
(3.916)
|
| Week 6: Functional Well-Being (n=275,302) |
0.24
(4.819)
|
-0.09
(4.711)
|
| Week 6: FACT-L Subscale Score (n=275,298) |
-0.06
(4.899)
|
0.24
(4.623)
|
| Week 6: Lung Cancer Subscale Score (n=275,298) |
-0.32
(4.148)
|
-0.03
(4.160)
|
| Week 6: Total FACT-G Score (n=273,299) |
-0.20
(12.256)
|
0.01
(11.453)
|
| Week 6: Trial Outcome Index (n=274,296) |
0.16
(10.276)
|
-0.73
(10.201)
|
| Week 6: Total FACT-L Score (n=273,294) |
-0.20
(15.133)
|
0.14
(14.155)
|
| Week 12: Physical Well-Being (n=144,193) |
1.00
(4.036)
|
-0.14
(4.908)
|
| Week 12: Social Well-Being (n=143,194) |
-0.43
(4.918)
|
-0.43
(5.566)
|
| Week 12: Emotional Well-Being (n=144,194) |
0.25
(3.728)
|
0.20
(4.115)
|
| Week 12: Functional Well-Being (n=144,196) |
1.00
(4.707)
|
-0.38
(4.806)
|
| Week 12: FACT-L Subscale Score (n=144,196) |
0.88
(4.501)
|
-0.06
(4.570)
|
| Week 12: Lung Cancer Subscale Score (n=144,196) |
0.19
(3.666)
|
-0.48
(4.004)
|
| Week 12: Total FACT-G Score (n=144,191) |
1.83
(11.637)
|
-0.84
(12.145)
|
| Week 12: Trial Outcome Index (n=144,193) |
2.20
(9.362)
|
-1.04
(10.051)
|
| Week 12: Total FACT-L Score (n=144,191) |
2.72
(14.226)
|
-0.90
(14.536)
|
| Week 18: Physical Well-Being (n=86,143) |
1.31
(4.798)
|
0.40
(4.890)
|
| Week 18: Social Well-Being (n=86,143) |
-0.01
(4.454)
|
-0.51
(5.894)
|
| Week 18: Emotional Well-Being (n=86,143) |
0.59
(3.984)
|
0.60
(3.723)
|
| Week 18: Functional Well-Being (n=86,143) |
1.06
(4.353)
|
0.18
(4.903)
|
| Week 18: FACT-L Subscale Score (n=86,143) |
1.48
(4.171)
|
0.27
(4.587)
|
| Week 18: Lung Cancer Subscale Score (n=86,143) |
0.49
(3.550)
|
-0.26
(4.125)
|
| Week 18: Total FACT-G Score (n=86,143) |
2.95
(12.047)
|
0.68
(12.668)
|
| Week 18: Trial Outcome Index (n=86,143) |
2.86
(9.638)
|
0.32
(10.350)
|
| Week 18: Total FACT-L Score (n=86,143) |
4.43
(14.523)
|
0.95
(15.386)
|
| Week 24: Physical Well-Being (n=59,101) |
1.29
(4.358)
|
0.16
(4.881)
|
| Week 24: Social Well-Being (n=59,101) |
-0.25
(4.804)
|
0.04
(6.092)
|
| Week 24: Emotional Well-Being (n=59,100) |
0.21
(5.118)
|
-0.05
(4.169)
|
| Week 24: Functional Well-Being (n=59,100) |
1.64
(4.550)
|
0.42
(4.373)
|
| Week 24: FACT-L Subscale Score (n=59,101) |
1.45
(5.018)
|
0.50
(5.048)
|
| Week 24: Lung Cancer Subscale Score (n=59,101) |
0.48
(4.051)
|
-0.12
(4.321)
|
| Week 24: Total FACT-G Score (n=59,99) |
2.89
(13.739)
|
0.52
(12.753)
|
| Week 24: Trial Outcome Index (n=59,100) |
3.42
(9.606)
|
0.43
(10.348)
|
| Week 24: Total FACT-L Score (n=59,99) |
4.34
(16.354)
|
1.10
(15.954)
|
| Week 30: Physical Well-Being (n=37,66) |
1.61
(4.205)
|
0.49
(5.129)
|
| Week 30: Social Well-Being (n=37,66) |
0.00
(5.510)
|
-0.19
(6.676)
|
| Week 30: Emotional Well-Being (n=37,66) |
-0.07
(4.902)
|
0.74
(4.775)
|
| Week 30: Functional Well-Being (n=37,66) |
2.17
(5.028)
|
0.83
(5.243)
|
| Week 30: FACT-L Subscale Score (n=37,66) |
1.79
(4.616)
|
0.99
(4.863)
|
| Week 30: Lung Cancer Subscale Score (n=37,66) |
0.69
(3.818)
|
0.38
(4.454)
|
| Week 30: Total FACT-G Score (n=37,66) |
3.71
(13.827)
|
1.88
(14.268)
|
| Week 30: Trial Outcome Index (n=37,66) |
4.47
(9.551)
|
1.70
(11.108)
|
| Week 30: Total FACT-L Score (n=37,66) |
5.50
(15.828)
|
2.86
(16.864)
|
| Week 36: Physical Well-Being (n=25,47) |
2.21
(4.791)
|
0.77
(5.093)
|
| Week 36: Social Well-Being (n=25,47) |
-0.36
(5.659)
|
-0.16
(7.053)
|
| Week 36: Emotional Well-Being (n=25,47) |
0.86
(4.892)
|
0.65
(3.717)
|
| Week 36: Functional Well-Being (n=25,47) |
1.31
(5.551)
|
1.10
(5.280)
|
| Week 36: FACT-L Subscale Score (n=25,47) |
0.67
(4.864)
|
0.43
(5.459)
|
| Week 36: Lung Cancer Subscale Score (n=25,47) |
-0.10
(3.963)
|
-0.06
(4.535)
|
| Week 36: Total FACT-G Score (n=25,47) |
4.02
(14.439)
|
2.37
(13.991)
|
| Week 36: Trial Outcome Index (n=25,47) |
3.42
(11.186)
|
1.82
(10.443)
|
| Week 36: Total Fact-L Score (n=25,47) |
4.68
(17.636)
|
2.79
(16.662)
|
| Week 42: Physical Well-Being (n=19,35) |
1.82
(3.936)
|
0.27
(5.835)
|
| Week 42: Social Well-Being (n=19,35) |
-1.14
(6.006)
|
0.28
(7.784)
|
| Week 42: Emotional Well-Being (n=19,35) |
-0.11
(3.573)
|
0.59
(3.741)
|
| Week 42: Functional Well-Being (n=19,35) |
0.05
(3.582)
|
0.65
(5.580)
|
| Week 42: FACT-L Subscale Score (n=19,35) |
1.40
(4.321)
|
0.87
(4.974)
|
| Week 42: Lung Cancer Subscale Score (n=19,35) |
0.42
(2.858)
|
0.51
(4.301)
|
| Week 42: FACT-G Score (n=19,35) |
0.62
(10.871)
|
1.80
(15.245)
|
| Week 42: Trial Outcome Index (n=19,35) |
2.29
(7.037)
|
1.44
(12.405)
|
| Week 42: FACT-L Score (n=19,35) |
2.03
(12.466)
|
2.67
(18.499)
|
| Week 48: Physical Well-Being (n=13,29) |
0.46
(3.497)
|
1.37
(6.388)
|
| Week 48: Social Well-Being (n=13,29) |
-1.96
(7.987)
|
-0.68
(6.851)
|
| Week 48: Emotional Well-Being (n=13,29) |
-0.08
(3.095)
|
0.41
(4.166)
|
| Week 48: Functional Well-Being (n=13,29) |
-2.00
(3.894)
|
0.55
(5.448)
|
| Week 48: FACT-L Subscale Score (n=12,29) |
0.03
(4.445)
|
0.82
(5.967)
|
| Week 48: Lung Cancer Subscale Score (n=12,29) |
-0.79
(3.100)
|
0.34
(5.150)
|
| Week 48: Total FACT-G Score (n=13,29) |
-3.57
(12.233)
|
1.64
(14.463)
|
| Week 48: Trial Outcome Index (n=12,29) |
-1.79
(7.570)
|
2.26
(13.247)
|
| Week 48: Total FACT-L Score (n=12,29) |
-1.60
(11.354)
|
2.46
(18.177)
|
| Week 60: Physical Well-Being (n=9,17) |
1.89
(5.383)
|
1.82
(6.307)
|
| Week 60: Social Well-Being (n=9,17) |
-0.57
(7.368)
|
0.06
(9.116)
|
| Week 60: Emotional Well-Being (n=9,17) |
-1.56
(2.789)
|
0.28
(4.478)
|
| Week 60: Functional Well-Being (n=9,17) |
-0.56
(3.877)
|
-0.53
(7.434)
|
| Week 60: FACT-L Subscale Score (n=9,17) |
1.61
(5.882)
|
0.43
(6.275)
|
| Week 60: Lung Cancer Subscale Score (n=9,17) |
-0.22
(4.438)
|
0.47
(5.535)
|
| Week 60: Total FACT-G Score (n=9,17) |
-0.79
(12.270)
|
1.64
(17.542)
|
| Week 60: Trial Outcome Index (n=9,17) |
1.11
(11.044)
|
1.76
(14.316)
|
| Week 60: Total FACT-L Score (n=9,17) |
0.82
(15.700)
|
2.07
(22.086)
|
| Week 72: Physical Well-Being (n=6,8) |
1.33
(6.318)
|
2.63
(7.130)
|
| Week 72: Social Well-Being (n=6,8) |
0.31
(6.723)
|
0.30
(3.733)
|
| Week 72: Emotional Well-Being (n=6,8) |
-1.50
(3.619)
|
-0.13
(4.853)
|
| Week 72: Functional Well-Being (n=6,8) |
-1.67
(5.354)
|
-1.13
(5.384)
|
| Week 72: FACT-L Subscale Score (n=6,8) |
-0.50
(7.396)
|
1.03
(4.818)
|
| Week 72: Lung Cancer Subscale Score (n=6,8) |
-1.17
(5.193)
|
1.78
(4.141)
|
| Week 72: Total FACT-G Score (n=6,8) |
-1.53
(11.929)
|
1.67
(14.651)
|
| Week 72: Trial Outcome Index (n=6,8) |
-1.50
(13.097)
|
3.28
(13.738)
|
| Week 72: Total FACT-L Score (n=6,8) |
-2.03
(16.140)
|
2.70
(17.579)
|
| Week 84: Physical Well-Being (n=1,0) |
1.33
(NA)
|
NA
(NA)
|
| Week 84: Social Well-Being (n=1,0) |
-2.00
(NA)
|
NA
(NA)
|
| Week 84: Emotional Well-Being (n=1,0) |
-3.00
(NA)
|
NA
(NA)
|
| Week 84: Functional Well-Being (n=1,0) |
-1.00
(NA)
|
NA
(NA)
|
| Week 84: FACT-L Subscale Score (n=1,0) |
6.0
(NA)
|
NA
(NA)
|
| Week 84: Lung Cancer Subscale Score (n=1,0) |
2.0
(NA)
|
NA
(NA)
|
| Week 84: Total FACT-G Score (n=1,0) |
-4.67
(NA)
|
NA
(NA)
|
| Week 84: Trial Outcome Index (n=1,0) |
2.33
(NA)
|
NA
(NA)
|
| Week 84: Total FACT-L Score (n=1,0) |
1.33
(NA)
|
NA
(NA)
|
| Off Trtmt: Physical Well-Being (n=264,214) |
-1.07
(4.750)
|
-2.19
(5.506)
|
| Off Trtmt: Social Well-Being (n=263,216) |
-0.66
(4.973)
|
0.09
(4.824)
|
| Off Trtmt: Emotional Well-Being (n=264,216) |
-2.04
(4.225)
|
-1.56
(4.745)
|
| Off Trtmt: Functional Well-Being (n=264,216) |
-1.20
(5.170)
|
-1.98
(5.355)
|
| Off Trtmt: FACT-L Subscale Score (n=263,212) |
-1.27
(4.458)
|
-1.32
(4.708)
|
| Off Trtmt: Lung Cancer Subscale Score (n=263,212) |
-1.74
(3.882)
|
-1.78
(4.199)
|
| Off Trtmt: Total FACT-G Score (n=260,213) |
-4.91
(12.576)
|
-5.71
(13.588)
|
| Off Trtmt: Trial Outcome Index (n=261,210) |
-4.03
(10.658)
|
-6.05
(11.785)
|
| Off Trtmt: Total FACT-L Score (n=258,209) |
-6.26
(15.146)
|
-7.10
(16.194)
|
Adverse Events
| Time Frame | Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis. | |||
| Arm/Group Title | Placebo | Erlotinib, 150 mg/Day | ||
| Arm/Group Description | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | ||
All Cause Mortality |
||||
| Placebo | Erlotinib, 150 mg/Day | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Placebo | Erlotinib, 150 mg/Day | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/445 (7.6%) | 49/433 (11.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/445 (0%) | 1/433 (0.2%) | ||
| Cardiac disorders | ||||
| Cardio-respiratory arrest | 0/445 (0%) | 2/433 (0.5%) | ||
| Cardiac failure | 0/445 (0%) | 1/433 (0.2%) | ||
| Cardiac tamponade | 1/445 (0.2%) | 0/433 (0%) | ||
| Left ventricular dysfunction | 0/445 (0%) | 1/433 (0.2%) | ||
| Myocardial infarction | 1/445 (0.2%) | 0/433 (0%) | ||
| Aortic aneurysm | 0/445 (0%) | 1/433 (0.2%) | ||
| Eye disorders | ||||
| Diplopia | 1/445 (0.2%) | 0/433 (0%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 0/445 (0%) | 4/433 (0.9%) | ||
| Vomiting | 2/445 (0.4%) | 0/433 (0%) | ||
| Dysphagia | 1/445 (0.2%) | 0/433 (0%) | ||
| Gastric perforation | 0/445 (0%) | 1/433 (0.2%) | ||
| Gastric ulcer perforation | 0/445 (0%) | 1/433 (0.2%) | ||
| Haematemesis | 0/445 (0%) | 1/433 (0.2%) | ||
| General disorders | ||||
| Asthenia | 1/445 (0.2%) | 0/433 (0%) | ||
| Chest pain | 0/445 (0%) | 1/433 (0.2%) | ||
| Drowning | 0/445 (0%) | 1/433 (0.2%) | ||
| Pyrexia | 0/445 (0%) | 1/433 (0.2%) | ||
| Sudden death | 0/445 (0%) | 1/433 (0.2%) | ||
| Hepatobiliary disorders | ||||
| Cholelithiasis | 0/445 (0%) | 1/433 (0.2%) | ||
| Infections and infestations | ||||
| Pneumonia | 4/445 (0.9%) | 7/433 (1.6%) | ||
| Bronchitis | 2/445 (0.4%) | 0/433 (0%) | ||
| Lower respiratory tract infection | 1/445 (0.2%) | 1/433 (0.2%) | ||
| Respiratory tract infection | 1/445 (0.2%) | 1/433 (0.2%) | ||
| Catheter sepsis | 1/445 (0.2%) | 0/433 (0%) | ||
| Cellulitis | 0/445 (0%) | 2/433 (0.5%) | ||
| Empyema | 1/445 (0.2%) | 0/433 (0%) | ||
| Lung abscess | 0/445 (0%) | 1/433 (0.2%) | ||
| Nocardiosis | 1/445 (0.2%) | 0/433 (0%) | ||
| Pyelonephritis acute | 0/445 (0%) | 1/433 (0.2%) | ||
| Sepsis | 0/445 (0%) | 1/433 (0.2%) | ||
| Staphylococcal abscess | 0/445 (0%) | 1/433 (0.2%) | ||
| Upper respiratory tract infection | 0/445 (0%) | 1/433 (0.2%) | ||
| Colitis | 0/445 (0%) | 1/433 (0.2%) | ||
| Injury, poisoning and procedural complications | ||||
| Femur fracture | 2/445 (0.4%) | 0/433 (0%) | ||
| Spinal compression fracture | 0/445 (0%) | 1/433 (0.2%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 0/445 (0%) | 1/433 (0.2%) | ||
| Aspartate aminotransferase increased | 0/445 (0%) | 1/433 (0.2%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 0/445 (0%) | 1/433 (0.2%) | ||
| Dehydration | 0/445 (0%) | 1/433 (0.2%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Muscular weakness | 1/445 (0.2%) | 0/433 (0%) | ||
| Pain in extremity | 1/445 (0.2%) | 0/433 (0%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 1/445 (0.2%) | 1/433 (0.2%) | ||
| Dizziness | 0/445 (0%) | 1/433 (0.2%) | ||
| Intracranial pressure increased | 0/445 (0%) | 1/433 (0.2%) | ||
| Neuralgia | 0/445 (0%) | 1/433 (0.2%) | ||
| Neuropathy peripheral | 0/445 (0%) | 1/433 (0.2%) | ||
| Peripheral motor neuropathy | 0/445 (0%) | 1/433 (0.2%) | ||
| Sciatica | 1/445 (0.2%) | 0/433 (0%) | ||
| Syncope | 0/445 (0%) | 1/433 (0.2%) | ||
| Psychiatric disorders | ||||
| Depression | 0/445 (0%) | 1/433 (0.2%) | ||
| Panic attack | 0/445 (0%) | 1/433 (0.2%) | ||
| Renal and urinary disorders | ||||
| Renal failure acute | 0/445 (0%) | 1/433 (0.2%) | ||
| Urogenital haemorrhage | 0/445 (0%) | 1/433 (0.2%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 2/445 (0.4%) | 2/433 (0.5%) | ||
| Haemoptysis | 2/445 (0.4%) | 1/433 (0.2%) | ||
| Interstitial lung disease | 0/445 (0%) | 2/433 (0.5%) | ||
| Pleural effusion | 1/445 (0.2%) | 1/433 (0.2%) | ||
| Pulmonary embolism | 2/445 (0.4%) | 0/433 (0%) | ||
| Bronchospasm | 1/445 (0.2%) | 0/433 (0%) | ||
| Chronic obstructive pulmonary disease | 1/445 (0.2%) | 0/433 (0%) | ||
| Epistaxis | 1/445 (0.2%) | 0/433 (0%) | ||
| Pleural fistula | 0/445 (0%) | 1/433 (0.2%) | ||
| Pneumonia aspiration | 1/445 (0.2%) | 0/433 (0%) | ||
| Pulmonary fibrosis | 0/445 (0%) | 1/433 (0.2%) | ||
| Respiratory failure | 0/445 (0%) | 1/433 (0.2%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 0/445 (0%) | 2/433 (0.5%) | ||
| Vascular disorders | ||||
| Peripheral ischaemia | 1/445 (0.2%) | 1/433 (0.2%) | ||
| Arterial thrombosis | 1/445 (0.2%) | 0/433 (0%) | ||
| Arteritis | 1/445 (0.2%) | 0/433 (0%) | ||
| Deep vein thrombosis | 1/445 (0.2%) | 0/433 (0%) | ||
| Iliac artery thrombosis | 0/445 (0%) | 1/433 (0.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Placebo | Erlotinib, 150 mg/Day | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 152/445 (34.2%) | 283/433 (65.4%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 20/445 (4.5%) | 87/433 (20.1%) | ||
| Nausea | 27/445 (6.1%) | 33/433 (7.6%) | ||
| General disorders | ||||
| Fatigue | 26/445 (5.8%) | 39/433 (9%) | ||
| Chest pain | 28/445 (6.3%) | 14/433 (3.2%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 22/445 (4.9%) | 39/433 (9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 38/445 (8.5%) | 36/433 (8.3%) | ||
| Dyspnoea | 37/445 (8.3%) | 33/433 (7.6%) | ||
| Haemoptysis | 21/445 (4.7%) | 22/433 (5.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Rash | 26/445 (5.8%) | 211/433 (48.7%) | ||
| Pruritus | 12/445 (2.7%) | 32/433 (7.4%) | ||
| Acne | 0/445 (0%) | 27/433 (6.2%) | ||
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.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffman-LaRoche |
| Phone | 800-821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00556712
Other Study ID Numbers:
- BO18192
First Posted:
Nov 12, 2007
Last Update Posted:
Feb 11, 2015
Last Verified:
Jan 1, 2015