Clinical Outcomes With Perioperative Nivolumab by Nodal Status in Patients With Stage III Resectable Nsclc: Phase 3 CheckMate 77T Exploratory Analysis

Authors

Mariano Provencio
Mark M Awad
Jonathan D Spicer
Annelies Janssens
Fedor Moiseyenko
Yang Gao
Yasutaka Watanabe
Aurelia Alexandru
Florian Guisier
Nikolaj Frost
Fabio Franke
T Jeroen Nicolaas Hiltermann
Jie He
Fumihiro Tanaka
Shun Lu
Cinthya Coronado Erdmann
Padma Sathyanarayana
Phuong Tran
Vipul Devas
Tina Cascone

Publication Date

1-1-2026

Journal

Nature Cancer

DOI

10.1038/s43018-025-01104-z

PMID

41507539

PMCID

PMC12858404

PubMedCentral® Posted Date

1-8-2026

PubMedCentral® Full Text Version

Post-print

Abstract

Individuals with non-small-cell lung cancer (NSCLC) with metastases to the ipsilateral mediastinum or subcarinal lymph nodes (N2 disease) have poor long-term survival. This exploratory analysis from the randomized phase 3 CheckMate 77T study assessed clinical outcomes by nodal status in individuals with stage III NSCLC who received neoadjuvant nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab (nivolumab) versus neoadjuvant chemotherapy followed by surgery and adjuvant placebo (placebo). Here we show that among patients with N2 disease, nivolumab versus placebo improved event-free survival (1-year rate, 70% versus 45%; hazard ratio, 0.46 (95% confidence interval, 0.30–0.70)) and pathological complete response rate (22.0% versus 5.6%); 77% versus 73% had definitive surgery, of whom 84% versus 74% received a simple lobectomy. Furthermore, nivolumab improved outcomes versus placebo in patients with multistation N2 NSCLC (1-year event-free survival rate: 71% versus 46%; hazard ratio, 0.43 (0.21–0.88); pathological complete response rate, 29.0% versus 2.7%). In the N2 subgroup with definitive surgery, 67% and 59% of patients had nodal downstaging after surgery (57% versus 44% downstaged to node-negative disease). Median EFS in randomized patients with stage III non-N2 NSCLC was not reached with nivolumab and 17.0 months with placebo (1-year EFS rate, 74% versus 62%; hazard ratio, 0.60 (0.33–1.08)). No new safety signals were identified. These findings support perioperative nivolumab plus neoadjuvant chemotherapy as an efficacious treatment for stage III N2 disease and suggest that N2 status may not predict poor prognosis in resectable NSCLC treated with perioperative immunotherapy. ClinicalTrials.gov identifier: NCT04025879.

Keywords

Humans, Nivolumab, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Male, Female, Middle Aged, Aged, Neoplasm Staging, Neoadjuvant Therapy, Lymphatic Metastasis, Treatment Outcome, Chemotherapy, Adjuvant, Adult, Lymph Nodes, Pneumonectomy, Antineoplastic Combined Chemotherapy Protocols, Non-small-cell lung cancer, Cancer immunotherapy, Drug development, Surgical oncology, Cancer

Published Open-Access

yes

Recommended Citation

Provencio, Mariano; Awad, Mark M; Spicer, Jonathan D; et al., "Clinical Outcomes With Perioperative Nivolumab by Nodal Status in Patients With Stage III Resectable Nsclc: Phase 3 CheckMate 77T Exploratory Analysis" (2026). Faculty, Staff and Student Publications. 401.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/401