NCT07320105

Postoperative Radiotherapy for Postoperative N2 Metastases of NSCLC in the Immunotherapy Era (Phase II)

Efficacy of Postoperative Radiotherapy in Patients With Multiple Postoperative N2 Metastases From Non-Small Cell Lung Cancer in the Immunotherapy Era: A Multicenter Prospective Controlled Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted at Fujian Provincial Cancer Hospital. Its main goals are to evaluate the progression-free survival (PFS) and safety of postoperative immunotherapy combined with radiotherapy in patients with high-risk stage Ⅲ N2 non-small cell lung cancer after surgery. It will also assess the overall survival (OS) of this treatment as a secondary goal. This study has been approved by the Medical Ethics Committee of Fujian Provincial Cancer Hospital, and the rights and safety of all participants will be fully protected during the trial.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tislelizumab + platinum-based chemotherapy	Tislelizumab (200mg IV every 3 weeks) combined with platinum-based chemotherapy (postoperative adjuvant regimen).
DRUG	Tislelizumab + platinum-based chemotherapy + focal radiotherapy	Tislelizumab + platinum-based chemotherapy (same as above) plus focal radiotherapy (50Gy total dose to the lesion).

Timeline

• Start date: 2026-01-15
• Primary completion: 2027-01-15
• Completion: 2029-01-31
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: China