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

NCT ID: NCT06878274

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2030-02-28

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 80 patients, stratifying by adjuvant immunotherapy use, with follow-up extending up to 5 years. Statistical analysis aims to detect a 15% improvement in 3-year EFS, with a total study duration of 8 years.

Conditions

Non Small Cell Lung Cancer; Stage III Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Post-operative radiotherapy

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

Group Type: EXPERIMENTAL

Post-operative radiotherapy

Intervention Type: RADIATION

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

No post-operative radiotherapy

No post-operative radiotherapy (PORT)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Post-operative radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

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 3-4 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Houda Bahig

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Houda Bahig, MD PhD

Role: CONTACT

houda.bahig.med@ssss.gouv.qc.ca

514-890-8254

Mom Phat

Role: CONTACT

mom.phat.chum@ssss.gouv.qc.ca

514-890-8254

Other Identifiers

RESCUE

Identifier Type: -

Identifier Source: org_study_id