A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing Chemotherapy
IMpower210
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
1 other identifier
interventional
565
5 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2016
Longer than P75 for phase_3
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 27, 2022
CompletedJanuary 10, 2023
January 1, 2023
3.1 years
June 23, 2016
January 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Baseline until death from any cause (up to approximately 3 years)
Secondary Outcomes (10)
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)
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)
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)
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)
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)
- +5 more secondary outcomes
Study Arms (2)
Atezolizumab
EXPERIMENTALParticipants 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.
Docetaxel
ACTIVE COMPARATORParticipants 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.
Interventions
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Docetaxel will be administered as 75 milligrams per square meter (mg/m\^2) via IV infusion on Day 1 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Chest Hospital; Oncology Department
Beijing, 101149, China
Affiliated Hospital of Bengbu Medical College
Bengbu, 233004, China
the First Hospital of Jilin University
Changchun, 130021, China
Jilin Cancer Hospital
Changchun, 132013, China
Changzhou First People's Hospital
Changzhou, 213003, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Second Affiliated Hospital of Third Military Medical University
Chongqing, 400030, China
Third Affiliated Hospital of Third Military Medical University
Chongqing, 400042, China
Guangdong General Hospital
Guangzhou, 510080, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
Sun Yet-sen University Cancer Center
Guangzhou, 510663, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, 310003, China
Sir Run Run Shaw Hospital
Hangzhou, 310018, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jiangsu Cancer Hospital
Nanjing, 211100, China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003, China
Shanghai chest hospital
Shanghai, 200030, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Liaoning cancer Hospital & Institute
Shenyang, 110042, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an, 710061, China
Zhejiang Cancer Hospital
Zhejiang, 310022, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
Sarawak, Sarawak, 93586, Malaysia
Hospital Sultan Ismail; Oncology
Johor Bahru, 81100, Malaysia
Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
Kuala Lumpur, 50586, Malaysia
National Cancer Centre; Medical Oncology
Singapore, 169610, Singapore
Kyungpook National University Medical Center
Daegu, 41404, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Chulalongkorn Hospital; Medical Oncology
Bangkok, 10330, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit
Chiang Mai, 50200, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 27, 2016
Study Start
July 1, 2016
Primary Completion
August 1, 2019
Study Completion
December 27, 2022
Last Updated
January 10, 2023
Record last verified: 2023-01