CheckMate 227 — Nivolumab Plus Ipilimumab Versus Chemotherapy as First-Line Treatment in Stage IV or Recurrent NSCLC

Phase 3 · 2019 · Non-Small Cell Lung Cancer

Design

Randomized nivolumab plus ipilimumab vs chemotherapy (and other arms) stratified by PD-L1 status.

Population

Untreated stage IV or recurrent NSCLC without EGFR/ALK alterations.

Primary Endpoint

overall survival (OS) in PD-L1 >=1% and PFS by tumor mutational burden

Key Result

OS in PD-L1 >=1%: 17.1 vs 14.9 mo (HR 0.79); durable 6-yr OS benefit across PD-L1 subgroups.

Guideline Impact

NCCN-recommended first-line nivolumab plus ipilimumab for metastatic NSCLC