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