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Clinical Trials in Canada / NCT06878274
Recruiting Phase 2

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

NCT06878274 · tracked via the Priya Life Science Canada tracker
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Phase
Phase 2
Started
2026-01-29
Last updated
2026-08-14

Condition(s) studied

Non Small Cell Lung CancerStage III Lung Cancer

Investigational drug(s) / intervention(s)

Post-operative radiotherapy

Post-operative radiotherapy: Mediastinal post-operative radiotherapy to a dose of 40 Gy in 15 fractions

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Participants must be ≥ 18 years old 2. Ability to provide written informed consent 3. ECOG performance status 0-2 4. Histologically confirmed NSCLC 5. Absence of actionable driver mutation (EGFR/ALK/ROS) 6. Complete preoperative imaging staging, including: FDG-PET and brain imaging to exclude distant metastases will be mandatory. 7. Baseline clinical or post-operative pathological stage III including specifically stage T1-4N2-3 8. Completion of 2-4 cycles of neoadjuvant chemo-IO, regardless of the specific immunotherapy and chemotherapy used. 9. Status post-complete (R0) surgical resection with mediastinal lymph node dissection. 10. Residual nodal disease on final pathology specimen (i.e. absence of pathological complete response). 11. Postoperative lung function examination: FEV1 \> 1 L (or greater than 35% expected value) Exclusion Criteria: 1. Pregnant individuals 2. Previous chest radiotherapy 3. \>24 weeks after thoracic surgery 4. History of other non-cutaneous neoplasms within the last 24 months 5. Active grade ≥ 2 pneumonitis. 6. Presence of interstitial lung disease 7. Recurrence or metastasis occurred 8. Medical conditions that hinders the safe administration of radiotherapy or follow-up.

Primary outcome measure(s)

  • Disease-free Survival — Defined as the time from random assignment to loco-regional or distant recurrence, or death from any cause, assessed up to 60 months.

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier de l'Université de Montréal Montreal Quebec Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06878274 on ClinicalTrials.gov ↗ ← All trials in Canada