Postoperative radiotherapy after chemo-immunotherapy and surgery for stage III non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase II trial enrolling 118 patients with stage III NSCLC who have residual nodal disease following neoadjuvant chemo-immunotherapy and complete (R0) surgical resection. Participants are randomly assigned to receive postoperative radiotherapy (targeting involved lymph node regions) or no postoperative radiotherapy, with stratification by use of adjuvant immunotherapy. The primary endpoint is event-free survival, with secondary endpoints including overall survival, locoregional and distant control, toxicity, and quality of life, and follow-up extending up to five years. The trial is sized to detect a 15% absolute improvement in 2-year event-free survival and has an overall planned duration of about seven years.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centre Hospitalier de l'Université de Montréal
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Houda Bahig, MD PhD
• Email: houda.bahig.med@ssss.gouv.qc.ca
• Phone: 514-890-8254

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.