RecruitingPhase 2NCT06878274

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

Radiotherapy to Optimize Event-free Survival Following Chemo-Immunotherapy and Surgery in Upper Stage III NSCLC With Evidence of Pathological Residual Disease (RESCUE): Phase II Trial


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

118 participants

Start Date

Jan 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether radiation therapy after surgery improves outcomes for people with stage III non-small cell lung cancer (NSCLC) who first received chemotherapy plus immunotherapy before surgery. The goal is to find out if post-operative radiation can lower the chance of the cancer coming back. **You may be eligible if:** - You are 18 or older with a confirmed diagnosis of non-small cell lung cancer - You have stage III disease - Your tumor does not have certain gene changes (EGFR, ALK, or ROS mutations) - You received chemotherapy combined with immunotherapy before surgery - You had surgery to remove the lung tumor - You are in good enough health to receive radiation (ECOG performance status 0–2) **You may NOT be eligible if:** - Your tumor has driver mutations like EGFR or ALK - You did not receive pre-surgery chemotherapy and immunotherapy - You are pregnant or breastfeeding - You have serious heart, lung, or immune conditions that would make radiation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONPost-operative radiotherapy

Mediastinal post-operative radiotherapy to a dose of 40 Gy in 15 fractions


Locations(1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

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NCT06878274


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