A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 3
- Intervention
- Atezolizumab
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 8
- Locations
- 82
- Primary Endpoint
- Progression-Free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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 Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.
Investigators
Eligibility Criteria
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
Arms & Interventions
Atezolizumab
Participants will receive intravenous (IV) infusion of atezolizumab once on Day 1 of each 21-day cycle until loss of clinical benefit.
Intervention: Atezolizumab
Gemcitabine + Cisplatin/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.
Intervention: Carboplatin
Gemcitabine + Cisplatin/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.
Intervention: Cisplatin
Gemcitabine + Cisplatin/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.
Intervention: Gemcitabine
Outcomes
Primary Outcomes
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)