A Study of Atezolizumab Compared With Gemcitabine Plus (+) Cisplatin or Carboplatin for PD-L1-Selected Participants With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) (IMpower111)

Phase 3

Terminated

Interventions: Drug: Carboplatin
Drug: Atezolizumab
Drug: Cisplatin
Drug: Gemcitabine

Brief Summary: 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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.

Recruitment & Eligibility

Inclusion Criteria

Histologically or cytologically confirmed Stage IV squamous NSCLC
Tumor programmed death-ligand 1 (PD-L1) expression, as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening
No prior treatment for Stage IV squamous NSCLC
Measurable disease as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hematologic and end-organ function

Exclusion Criteria

Active or untreated central nervous system (CNS) metastases
Untreated or inadequately treated spinal cord compression
Leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites
Uncontrolled tumor-related pain
Uncontrolled hypercalcemia
Any other malignancies within 5 years except those with negligible risk of metastasis or death
Pregnant or lactating women
Known hypersensitivity to any component of atezolizumab formulation or other study medication
History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes
Prior allogeneic bone marrow or solid organ transplantation
Positive human immunodeficiency virus (HIV) test
Active hepatitis B or C
Active tuberculosis
Significant cardiovascular disease
Severe infection or major surgery within 4 weeks prior to randomization
Use of any approved anti-cancer therapy within 3 weeks prior to treatment
Use of an investigational agent or participation in another clinical trial within 4 weeks prior to randomization
Exposure to oral or IV antibiotics within 2 weeks or live attenuated vaccines within 4 weeks prior to randomization
Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies
Treatment with immunostimulatory agents within 4 weeks or immunosuppressive agents within 2 weeks prior to randomization

Arm && Interventions

Group	Intervention	Description
Gemcitabine + Cisplatin/Carboplatin	Gemcitabine	Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
Gemcitabine + Cisplatin/Carboplatin	Carboplatin	Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.
Atezolizumab	Atezolizumab	Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
Gemcitabine + Cisplatin/Carboplatin	Cisplatin	Participants will receive IV infusion of gemcitabine + cisplatin or gemcitabine + carboplatin once on Day 1 of each 21-day cycle for four or six cycles as per local standard of care.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	Baseline up to death or disease progression, whichever occurs first (up to approximately 2.5 years)

Secondary Outcome Measures

Name	Time	Method

Locations (82): 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
Georgetown University Medical Center
🇺🇸
Washington, District of Columbia, United States
Mount Sinai Medical Center
🇺🇸
Miami Beach, Florida, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Straub Clinic & Hospital; Oncology
🇺🇸
Honolulu, Hawaii, United States
Ingalls Memorial Hospital
🇺🇸
Harvey, Illinois, United States
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California Cancer Associates for Research & Excellence, Inc.
🇺🇸Encinitas, California, United States