Recruiting
Phase 2

PORT

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06878274

Conditions

Non Small Cell Lung Cancer

Stage III Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Post-operative radiotherapy

Study Details

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

Study ID

NCT06878274

Start date

Jan 29, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2032

Anticipated

Primary completion date

Feb, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Post-operative radiotherapy

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

no intervention: No post-operative radiotherapy

No post-operative radiotherapy (PORT)

Interventions

Post-operative radiotherapy

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H4C 3N4

Contacts

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-08-14.