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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
565
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.
Overall Survival (OS)
Time frame: Baseline until death from any cause (up to approximately 3 years)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Time frame: 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
Time frame: Baseline until disease progression or death from any cause (up to approximately 3 years)
Duration of Objective Response According to RECIST v1.1
Time frame: From first objective response until disease progression or death from any cause (up to approximately 3 years)
Percentage of Participants with Adverse Events
Time frame: 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
Time frame: 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)
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Time frame: 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)
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)
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Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China
Beijing Cancer Hospital
Beijing, China
Beijing Chest Hospital; Oncology Department
Beijing, China
Affiliated Hospital of Bengbu Medical College
Bengbu, China
the First Hospital of Jilin University
Changchun, China
Jilin Cancer Hospital
Changchun, China
Changzhou First People's Hospital
Changzhou, China
West China Hospital, Sichuan University
Chengdu, China
Second Affiliated Hospital of Third Military Medical University
Chongqing, China
Third Affiliated Hospital of Third Military Medical University
Chongqing, China
...and 28 more locations
Time frame: From start of treatment until treatment discontinuation (up to approximately 3 years)
TTD in Lung Cancer Symptoms According to EORTC QLQ Lung Cancer Module (LC13)
Time frame: From start of treatment until treatment discontinuation (up to approximately 3 years)
Health-Related Quality of Life According to EORTC QLQ-C30 Score
Time frame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)
Health-Related Quality of Life According to EORTC QLQ-LC13 Score
Time frame: Day 1 of every cycle (cycle length of 21 days) until/at treatment discontinuation (up to approximately 3 years)