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Recruiting NCT06878274

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

Phase II Interventional Non Small Cell Lung Cancer Stage III Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Post-operative radiotherapy.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer, Stage III Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • 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 outcome measures (4)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre Hospitalier de l'Université de Montréal — Montreal

Identifiers

NCT: NCT06878274 · RESCUE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗