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IMpower210: A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02813785
Collaborator
(none)
565
Enrollment
38
Locations
2
Arms
78
Anticipated Duration (Months)
14.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase III, multicenter, open-label, randomized, controlled study is designed to evaluate the efficacy and safety of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab compared with docetaxel in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression, loss of clinical benefit, or unacceptable toxicity.

Condition or Disease Intervention/Treatment Phase
  • Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
  • Drug: Docetaxel
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
565 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atezolizumab

Participants will receive atezolizumab until loss of clinical benefit and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.

Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Other Names:
  • MDPL3280A, RO5541267

    		•
    Active Comparator: Docetaxel

    Participants will receive docetaxel until disease progression per standard RECIST v1.1 criteria or unacceptable toxicity and will thereafter enter survival follow-up until death, loss to follow-up, withdrawal, or study end.

    Drug: Docetaxel
    Docetaxel will be administered as 75 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 21-day cycle.
    Other Names:
  • Taxotere

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Baseline until death from any cause (up to approximately 3 years)]

    Secondary Outcome Measures

    1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [Baseline until disease progression or death from any cause (up to approximately 3 years)]

    2. Percentage of Participants with Objective Response According to RECIST v1.1 [Baseline until disease progression or death from any cause (up to approximately 3 years)]

    3. Duration of Objective Response According to RECIST v1.1 [From first objective response until disease progression or death from any cause (up to approximately 3 years)]

    4. Percentage of Participants with Adverse Events [From start of treatment until 90 days after treatment discontinuation or initiation of other anti-cancer therapy (up to approximately 3 years)]

    5. Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) to Atezolizumab [Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall)]

    6. Minimum Observed Serum Concentration (Cmin) of Atezolizumab [Predose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, and every eight cycles thereafter (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years) and 120 days after last dose (up to approximately 3 years overall)]

    7. Time to Deterioration (TTD) in Lung Cancer Symptoms According to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 C30) [From start of treatment until treatment discontinuation (up to approximately 3 years)]

    8. TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13) [From start of treatment until treatment discontinuation (up to approximately 3 years)]

    9. Health-Related Quality of Life According to EORTC QLQ-C30 Score [Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)]

    10. Health-Related Quality of Life According to EORTC QLQ-LC13 Score [Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)]

    Eligibility Criteria

    Criteria

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

    • Histologically documented, locally advanced or metastatic NSCLC

    • Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status

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

    • Measurable disease per RECIST v1.1

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

    • Life expectancy greater than or equal to (>/=) 12 weeks

    • Adequate hematologic and end organ function

    • Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential

    • Recovery from all acute toxicities from previous therapy

    Exclusion Criteria:

    • Active or untreated central nervous system (CNS) metastases

    • Spinal cord compression not definitively treated or not clinically stable

    • Leptomeningeal disease

    • Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage

    • Uncontrolled tumor-related pain

    • Uncontrolled hypercalcemia

    • Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death

    • Pregnant or lactating women

    • Significant cardiovascular, pulmonary, or autoimmune disease

    • Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization

    • Prior treatment with or hypersensitivity to study drug(s) or related compounds

    • Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors

    • Prior allogeneic bone marrow or solid organ transplant

    • Known PD-L1-negative expression status

    • Positive human immunodeficiency virus (HIV) or active hepatitis B or C

    • Receipt of a live attenuated vaccine within 4 weeks prior to randomization

    • Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization

    • Treatment with systemic corticosteroids within 2 weeks prior to randomization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Hospital Chinese Academy of Medical Sciences. Beijing China 100021
    2 Beijing Cancer Hospital Beijing China 100142
    3 Beijing Chest Hospital; Oncology Department Beijing China 101149
    4 Affiliated Hospital of Bengbu Medical College Bengbu China 233004
    5 the First Hospital of Jilin University Changchun China 130021
    6 Jilin Cancer Hospital Changchun China 132013
    7 Changzhou First People's Hospital Changzhou China 213003
    8 West China Hospital, Sichuan University Chengdu China 610041
    9 Second Affiliated Hospital of Third Military Medical University Chongqing China 400030
    10 Third Affiliated Hospital of Third Military Medical University ChongQing China 400042
    11 Sun Yet-sen University Cancer Center Guangzhou China 510060
    12 Guangdong General Hospital Guangzhou China 510080
    13 The First Affiliated Hospital of Guangzhou Medical University Guangzhou China 510120
    14 The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou China 310003
    15 Sir Run Run Shaw Hospital Hangzhou China 310016
    16 Harbin Medical University Cancer Hospital Harbin China 150081
    17 Jiangsu Cancer Hospital Nanjing City China 211100
    18 The Affiliated Hospital of Medical College Qingdao University Qingdao China 266003
    19 Fudan University Shanghai Cancer Center Shanghai City China 200120
    20 Shanghai chest hospital Shanghai China 200030
    21 Zhongshan Hospital Fudan University Shanghai China 200032
    22 Liaoning cancer Hospital & Institute Shenyang China 110042
    23 Tianjin Medical University General Hospital Tianjin China 300052
    24 The First Affiliated Hospital of Xian Jiao Tong University Xi'an City China 710061
    25 Zhejiang Cancer Hospital Zhejiang China 310022
    26 Henan Cancer Hospital Zhengzhou China 450008
    27 Kyungpook National University Medical Center Daegu Korea, Republic of 41404
    28 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    29 Chonnam National University Hwasun Hospital Jeollanam-do Korea, Republic of 58128
    30 Korea University Guro Hospital Seoul Korea, Republic of 08308
    31 Hospital Sultan Ismail; Oncology Johor Bahru Malaysia 81100
    32 Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi Kuala Lumpur Malaysia 50586
    33 Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care Sarawak Malaysia 93586
    34 National Cancer Centre; Medical Oncology Singapore Singapore 169610
    35 Chulalongkorn Hospital; Medical Oncology Bangkok Thailand 10330
    36 Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc Bangkok Thailand 10400
    37 Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology Bangkok Thailand 10700
    38 CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit Chiang Mai Thailand 50200

    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:
    NCT02813785
    Other Study ID Numbers:
    • YO29232
    First Posted:
    Jun 27, 2016
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Docetaxel
    Atezolizumab
    Antibodies

    Study Results

    No Results Posted as of Aug 15, 2022