Status:
NOT_YET_RECRUITING
Post-operative Radiotherapy After Neodjuvant Chemo-immunotherapy and Surgery in Stage III NSCLC
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Non Small Cell Lung Cancer
Stage III Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-imm...
Eligibility Criteria
Inclusion
- 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 3-4 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06878274
Start Date
May 1 2025
End Date
February 1 2030
Last Update
March 14 2025
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