Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H4C 3N4, Canada
Location status: Recruiting
Recruiting
NCT Number: NCT06878274
Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- Pregnant individuals
- 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
- Recurrence or metastasis occurred
- Medical conditions that hinders the safe administration of radiotherapy or follow-up.
Treatment and study plan
Post-Operative Radiotherapy
RadiationMediastinal post-operative radiotherapy to a dose of 40 Gy in 15 fractions
Primary outcomes
-
Disease-free Survival
Time frame: Defined as the time from random assignment to loco-regional or distant recurrence, or death from any cause, assessed up to 60 months.
Secondary outcomes
-
Overall Survival
Time frame: Time from random assignment to death from any cause, assessed up to 60 months.
-
Grade 3 Toxicity
Time frame: Classified as early (within the first 3 months) or late (after 3 months), assessed up to 60 months.
-
Locoregional control
Time frame: Time from random assignment to locoregional recurrence, proven radiologically and/or pathologically, assessed up to 60 months.
-
Distant metastasis free survival
Time frame: Time from random assignment to distant recurrence, proven radiologically and/or pathologically, or death from any cause, assessed up to 60 months.
Study contacts
Contact information is provided by the study sponsor or research team.
Houda Bahig, MD PhD
CONTACT
Mom Phat
CONTACT
Sponsors and collaborators
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Registry information
Official study title
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
Acronym: RESCUE
Important dates
- Study start
- 2026
- Primary completion
- 2030
- Study completion
- 2032
- First posted
- Mar 14, 2025
- Registry last updated
- Feb 10, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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