CheckMate 816 — Neoadjuvant Nivolumab Plus Chemotherapy Versus Chemotherapy in Resectable NSCLC

Phase 3 · 2022 · Non-Small Cell Lung Cancer

Design

Randomized neoadjuvant nivolumab plus platinum-doublet chemotherapy vs chemotherapy alone for 3 cycles before surgery.

Population

Resectable stage IB-IIIA NSCLC without EGFR/ALK alterations.

Primary Endpoint

pathologic complete response (pCR) and event-free survival (EFS)

Key Result

pCR 24.0% vs 2.2%; median EFS 31.6 vs 20.8 mo (HR 0.63).

Guideline Impact

NCCN category 1 neoadjuvant nivolumab plus chemotherapy for resectable NSCLC