RecruitingPhase 4NCT07320105

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


Sponsor

Fujian Cancer Hospital

Enrollment

60 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding radiation therapy after surgery (postoperative radiotherapy) to immunotherapy and chemotherapy improves outcomes in people with non-small cell lung cancer (NSCLC) who had multiple lymph node metastases found after surgery. **You may be eligible if...** - You are 18 to 75 years old - You have had surgery for non-small cell lung cancer and pathology found at least 3 lymph node metastases in the mediastinum (N2 disease) - You have not had any prior radiotherapy, chemotherapy, or immunotherapy - You are in good physical condition (ECOG 0–2) with an expected survival of 3 months or more - Your major organ function is normal **You may NOT be eligible if...** - You have a known or suspected autoimmune disease - You have had an organ transplant or are immunocompromised (including HIV-positive) - You have interstitial lung disease or severe lung problems - You have poorly controlled heart disease (significant heart failure, recent heart attack, uncontrolled arrhythmia) - You have active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab + platinum-based chemotherapy

Tislelizumab (200mg IV every 3 weeks) combined with platinum-based chemotherapy (postoperative adjuvant regimen).

DRUGTislelizumab + platinum-based chemotherapy + focal radiotherapy

Tislelizumab + platinum-based chemotherapy (same as above) plus focal radiotherapy (50Gy total dose to the lesion).


Locations(1)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

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NCT07320105


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