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

August 13, 2026 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4C 3N4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal
        • Contact:
        • Contact:
          • Eva-Sabrina Nkurunziza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post-operative radiotherapy
Mediastinal PORT (40 Gy in 15 fractions) within 24 weeks from thoracic surgery
Radiation: Post-operative radiotherapy
Mediastinal post-operative radiotherapy to a dose of 40 Gy in 15 fractions
No Intervention: No post-operative radiotherapy
No post-operative radiotherapy (PORT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Defined as the time from random assignment to loco-regional or distant recurrence, or death from any cause, assessed up to 60 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Time from random assignment to death from any cause, assessed up to 60 months.
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.
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.
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.
Time from random assignment to distant recurrence, proven radiologically and/or pathologically, or death from any cause, assessed up to 60 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

February 1, 2032

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESCUE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD includes anonymized individual participant data collected throughout the course of the study and may include the analyzable data set.

IPD Sharing Time Frame

study completion date, up to 60 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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