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

NCT06878274 | Recruiting Phase 2 DMC

• 1 other identifier: RESCUE
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non Small Cell Lung Cancer; Stage III Lung Cancer

Keywords

Post operative radiotherapy; lung cancer; non small cell lung cancer; stage III lung cancer; neoadjuvant immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Overall Survival

  Time from random assignment to death from any cause, assessed up to 60 months.

• Grade 3 Toxicity

  Classified as early (within the first 3 months) or late (after 3 months), assessed up to 60 months.

• Locoregional control

  Time from random assignment to locoregional recurrence, proven radiologically and/or pathologically, assessed up to 60 months.

• Distant metastasis free survival

  Time from random assignment to distant recurrence, proven radiologically and/or pathologically, or death from any cause, assessed up to 60 months.

Study Arms (2)

Post-operative radiotherapy

EXPERIMENTAL

Mediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery

Radiation: Post-operative radiotherapy

No post-operative radiotherapy

NO INTERVENTION

No post-operative radiotherapy (PORT)

Interventions

Post-operative radiotherapy RADIATION

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

Post-operative radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H4C 3N4, Canada

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Houda Bahig, MD PhD

CONTACT

514-890-8254; houda.bahig.med@ssss.gouv.qc.ca

Mom Phat

CONTACT

514-890-8254; mom.phat.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: March 14, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): February 1, 2032
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: study completion date, up to 60 months.

Locations

CA (1)