A Phase 3, Randomized, Open-label Study

Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy versus Pembrolizumab with Chemotherapy

OS, PFS, ORR, safety

Histologically confirmed Stage IV or recurrent NSCLC of NSQ histology
No prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
Tumor cell PD-L1 expression ≥ 1%

• Symptomatic untreated CNS metastases or leptomeningeal metastases
• No EGFR, ALK, ROS-1, BRAF, RET, NTRK mutations
• Current of history of prior malignancy active within 2 years prior to treatment assignment
• requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of treatment assignment.
• symptomatic ascites or pleural effusion. A subject who is clinically stable per treating physicians discretion following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.