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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab + platinum-based chemotherapy; Drug: Tislelizumab + platinum-based chemotherapy + focal radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiancheng Li, MD; Phone Number: +86-13906900190; Email: jianchengli6@126.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Provincial Cancer Hospital
      • Contact: Jiancheng Li, MD; Phone Number: +86-13906900190; Email: jianchengli6@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: ≥18 years old and ≤75 years old, no gender restriction; Pathologically (histologically or cytologically) confirmed non-small cell lung cancer with multiple N2 metastasis after surgery; No prior radiotherapy, chemotherapy or immunotherapy; At least 3 lymph node metastases confirmed by postoperative pathology; ECOG PS score: 0-2; Expected survival time ≥3 months; Normal major organ function, with basically normal results of blood routine, blood biochemistry and coagulation function tests; Basically normal immune indicators; No severe underlying diseases or severe cardiopulmonary dysfunction.

Exclusion Criteria:

• Known or suspected active autoimmune diseases, or history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, etc.); History of immunodeficiency (including positive HIV test), other acquired/congenital immunodeficiency diseases, organ transplantation or allogeneic bone marrow transplantation; Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment, symptomatic active pneumonia, or severe pulmonary dysfunction; Poorly controlled cardiovascular symptoms or diseases (e.g., NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, uncontrolled arrhythmia); Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL) or hepatitis C (positive anti-HCV and HCV-RNA above detection limit); Hereditary bleeding tendency or coagulation dysfunction; bleeding symptoms within 3 months, or positive fecal occult blood (++ or above); Toxicity from prior anti-tumor therapy not recovered to ≤CTCAE grade 1 (except alopecia); Known or suspected allergy to the study drug; Pregnant or lactating women; Subjects deemed unsuitable for inclusion by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab + Chemotherapy Arm; This arm includes postoperative non-small cell lung cancer patients receiving Tislelizumab (standard intravenous dose) combined with platinum-based chemotherapy (adjuvant regimen), without additional radiotherapy.	Drug: Tislelizumab + platinum-based chemotherapy; Tislelizumab (200mg IV every 3 weeks) combined with platinum-based chemotherapy (postoperative adjuvant regimen).
Experimental: Tislelizumab + Chemotherapy + Radiotherapy Arm; This arm includes postoperative non-small cell lung cancer patients receiving Tislelizumab + platinum-based chemotherapy (same as Group A), plus focal radiotherapy (50Gy to the lesion area).	Drug: Tislelizumab + platinum-based chemotherapy + focal radiotherapy; Tislelizumab + platinum-based chemotherapy (same as above) plus focal radiotherapy (50Gy total dose to the lesion).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	The time from randomization to the first occurrence of disease progression (per RECIST 1.1 criteria) or death from any cause; assessed every 3 months.	Every 3 months, up to 24 months after randomization

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Inorganic Chemicals; Platinum Compounds; tislelizumab
• Other Study ID Numbers: NSCLC-RT-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: At the current stage, the IPD sharing plan has not yet been finalized. Following study completion, we will conduct a comprehensive evaluation of data sharing feasibility-including considerations related to participant privacy protection, data standardization, and regulatory compliance-before determining a specific sharing framework based on study progress and relevant requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No