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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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 criteria

Qualifiers

Participants must be ≥ 18 years old

Ability to provide written informed consent

ECOG performance status 0-2

Histologically confirmed NSCLC

Disqualifiers

Pregnant individuals

Previous chest radiotherapy

>24 weeks after thoracic surgery

History of other non-cutaneous neoplasms within the last 24 months

Trial design

Treatments tested in this trial

  • Post-operative radiotherapy

Treatment groups

118 Participants
are divided into 2 treatment groups