Actively Recruiting
Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-02-10
118
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older
- Able to provide written informed consent
- ECOG performance status between 0 and 2
- Histologically confirmed non-small cell lung cancer
- No actionable driver mutations such as EGFR, ALK, or ROS
- Complete preoperative imaging staging including FDG-PET and brain scans to rule out distant metastases
- Clinical or postoperative pathological stage III disease including T1-4N2-3
- Completed 2 to 4 cycles of neoadjuvant chemo-immunotherapy
- Completed surgery with mediastinal lymph node dissection and complete tumor removal (R0 resection)
- Residual nodal disease present on final pathology (no complete pathological response)
- Postoperative lung function with FEV1 greater than 1 liter or over 35% of predicted value
You will not qualify if you...
- Pregnant individuals
- Previous chest radiotherapy
- More than 24 weeks have passed since thoracic surgery
- History of other non-skin cancers within the last 24 months
- Active pneumonitis of grade 2 or higher
- Presence of interstitial lung disease
- Recurrence or metastasis of cancer
- Medical conditions that prevent safe radiotherapy or follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H4C 3N4
Actively Recruiting
Research Team
H
Houda Bahig, MD PhD
CONTACT
M
Mom Phat
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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