Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC

This study investigates whether postoperative radiotherapy (PORT) improves outcomes for patients with stage III non-small cell lung cancer (NSCLC) who have residual disease after neoadjuvant chemo-immunotherapy and surgery. The primary objective is to compare event-free survival (EFS) between patients receiving PORT targeting involved lymph node regions and those without PORT. Secondary and tertiary endpoints include overall survival, locoregional and distant control, toxicity, and quality of life. The phase II randomized trial will enroll 118 patients, stratifying by adjuvant immunotherapy use, with follow-up extending up to 5 years. Statistical analysis aims to detect a 15% improvement in 2-year EFS, with a total study duration of 7 years.

NCT Number	NCT06878274
Lead Sponsor	Centre hospitalier de l'Université de Montréal (CHUM)
Conditions	Non Small Cell Lung Cancer, Stage III Lung Cancer
Enrollment	118 participants
Start Date	2026-01-29
Primary Completion	2030-02 (estimated)
Study Completion	2032-02 (estimated)
Updated on ClinicalTrials.gov	2026-08-14