A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Completed · Phase 3
Conditions studied: Carcinoma, Non-Small-Cell Lung
In brief
This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).
Key facts
- Study ID
- NCT02366143
- Run by
- Hoffmann-La Roche
- People needed
- 1202
- Starts
- 2015-03-31
- Expected to finish
- 2020-12-07
- Last updated by the study team
- 2021-09-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group performance status 0 or 1
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
- Participants with no prior treatment for Stage IV non-squamous NSCLC
- Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end organ function
You may not qualify if…
- Cancer-Specific Exclusions:
- Active or untreated central nervous system metastases
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- General Medical Exclusions:
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Positive test for human immunodeficiency virus
- Active hepatitis B or hepatitis C
- Severe infection within 4 weeks prior to randomization
- Significant cardiovascular disease
- Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures
- Exclusion Criteria Related to Medications:
- Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
Where it is running
- Arizona Oncology Associates — Flagstaff, Arizona, United States
- Southern CA Permanente Med Grp — Bellflower, California, United States
- Marin Cancer Care Inc — Greenbrae, California, United States
- Scripps Health — La Jolla, California, United States
- Chao Family Comprehensive Cancer Center UCI — Orange, California, United States
- Rocky Mountain Cancer Center — Denver, Colorado, United States
- Kaiser Permanente — Lonetree, Colorado, United States
- Danbury Hospital — Danbury, Connecticut, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Holy Cross Hospital Inc — Fort Lauderdale, Florida, United States
- Cancer Specialists of North Florida - Baptist South — Jacksonville, Florida, United States
- Mount Sinai Medical Center — Miami Beach, Florida, United States
- Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
- Piedmont Cancer Institute, PC — Atlanta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Univ of Chicago — Chicago, Illinois, United States
- Ingalls Memorial Hospital — Harvey, Illinois, United States
- Oncology Specialists, S.C. — Park Ridge, Illinois, United States
- Hematology-Oncology; Associates of the Quad Cities — Bettendorf, Iowa, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- New England Cancer Specialists — Scarborough, Maine, United States
- Mercy Medical Center — Baltimore, Maryland, United States
- Regional Cancer Care Associates — Bethesda, Maryland, United States
- Maryland Oncology Hematology, P.A. — Columbia, Maryland, United States
- Ironwood Cancer & Research Centers — Chandler, Arizona, United States
Full record on ClinicalTrials.gov
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