This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
Cisplatin will be administered at 75 milligrams per square meter (mg/m\^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
Gemcitabine will be administered at 1000 mg/m\^2 (when coadministered with carboplatin) or 1250 mg/m\^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States
Marin Cancer Care Inc
Greenbrae, California, United States
University of California San Diego
La Jolla, California, United States
Chao Family Comprehensive Cancer Center; UC Irvine Medical Center
Orange, California, United States
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
Norwich, Connecticut, United States
Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)
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Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Mount Sinai Medical Center
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Florida Hospital
Orlando, Florida, United States
Straub Clinic & Hospital; Oncology
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Ingalls Memorial Hospital
Harvey, Illinois, United States
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