A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Completed · Phase 3
Conditions studied: Carcinoma, Non-Squamous Non-Small Cell Lung
In brief
This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).
Key facts
- Study ID
- NCT02367781
- Run by
- Hoffmann-La Roche
- People needed
- 723
- Starts
- 2015-04-16
- Expected to finish
- 2021-01-18
- Last updated by the study team
- 2021-08-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
- Participants with no prior treatment for Stage IV non-squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from fresh 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
- Kaiser Permanente Oakland Medical Center — Oakland, California, United States
- Kaiser Permanente Medical Center - Roseville — Roseville, California, United States
- Kaiser Permanente - Sacramento Medical Center and Medical Offices — Sacramento, California, United States
- Kaiser Permanente - San Francisco Medical Center — San Francisco, California, United States
- Kaiser Permanente - San Jose Medical Center — San Jose, California, United States
- Kaiser Permanente - San Leandro Medical Center — San Leandro, California, United States
- Kaiser Permanente - Santa Clara — Santa Clara, California, United States
- Kaiser Permanente - South San Francisco — South San Francisco, California, United States
- Kaiser Permanente; Oncology Clinical Trials — Vallejo, California, United States
- Kaiser Permanente - Walnut Creek — Walnut Creek, California, United States
- Banner MD Anderson Cancer Center — Greeley, Colorado, United States
- Eastern Connecticut Hematology and Oncology Associates; (ECHO) — Norwich, Connecticut, United States
- University of Miami School of Medicine - Sylvester at Deerfield — Deerfield Beach, Florida, United States
- SCRI Florida Cancer Specialists South — Fort Myers, Florida, United States
- Florida Hospital — Orlando, Florida, United States
- Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) — St. Petersburg, Florida, United States
- SCRI Florida Cancer Specialists East — West Palm Beach, Florida, United States
- University Cancer & Blood Center, LLC; Research — Athens, Georgia, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital — Carrollton, Georgia, United States
- Suburban Hematology / Oncology Associates — Lawrenceville, Georgia, United States
- Southeastern Regional Medical Center, Inc. — Newnan, Georgia, United States
- University of Illinois at Chicago — Chicago, Illinois, United States
- Joliet Oncology-Hematology; Associates, Ltd. — Joliet, Illinois, United States
- Illinois Cancer Care — Peoria, Illinois, United States
- Highlands Oncology Group — Springdale, Arkansas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.