A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%
Bristol-Myers Squibb
Summary
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. * Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization. * Participants must have measurable disease by computed tomography (CT) or magnetic resona…
Interventions
- DrugNivolumab
Specified dose on specified days
- DrugRelatlimab
Specified dose on specified days
- DrugPembrolizumab
Specified dose on specified days
- DrugCarboplatin
Specified dose on specified days
- DrugPemetrexed
Specified dose on specified days
- DrugCisplatin
Specified dose on specified days
Locations (299)
- Local Institution - 0487Mobile, Alabama
- Southern Arizona VA Health Care SystemTucson, Arizona
- Local Institution - 0112Los Angeles, California
- University of California Davis (UC Davis) Comprehensive Cancer CenterSacramento, California
- San Francisco Oncology AssociatesSan Francisco, California
- UCLA Hematology/Oncology - Santa MonicaSanta Monica, California