Tests radiation after surgery in non-small cell lung cancer with leftover disease
Tests radiation after surgery in adults with non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC
Key facts
- Where
- Montreal, CanadaSee the site
- Phase
- Phase 2
Where in Canada
- Centre Hospitalier de l'Université de MontréalMontreal, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre hospitalier de l'Université de Montréal (CHUM)
- Trial code
- NCT06878274
- Record updated
- 14 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants must be ≥ 18 years old; Ability to provide written informed consent; ECOG performance status 0-2; Histologically confirmed NSCLC; Absence of actionable driver mutation (EGFR/ALK/ROS); Complete preoperative imaging staging, including: FDG-PET and brain imaging to exclude distant metastases will be mandatory; Baseline clinical or post-operative pathological stage III including specifically stage T1-4N2-3; Completion of 2-4 cycles of neoadjuvant chemo-IO, regardless of the specific immunotherapy and chemotherapy used; Status post-complete (R0) surgical resection with mediastinal lymph node dissection; Residual nodal disease on final pathology specimen (i.e. absence of pathological complete response); Postoperative lung function examination: FEV1 > 1 L (or greater than 35% expected value).
Exclusion: Previous chest radiotherapy; >24 weeks after thoracic surgery; History of other non-cutaneous neoplasms within the last 24 months; Active grade ≥ 2 pneumonitis; Presence of interstitial lung disease; Medical conditions that hinders the safe administration of radiotherapy or follow-up; Pregnant individuals; Recurrence or metastasis occurred.