NCT06878274RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 4 Dec 2024
- Start date
- 29 Jan 2026
- Primary completion date
- Feb 2030
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Diseases
- Lung cancer
- NCT number
- NCT06878274
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 118
- From 29 Jan 2026 to the primary completion date, Feb 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chest radiotherapy
- \>24 weeks after thoracic surgery
Other illness
- 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.
Other
- Pregnant individuals
- Recurrence or metastasis occurred
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.