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

NCT07320105 | Recruiting Phase 4

• 1 other identifier: NSCLC-RT-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tislelizumab + Chemotherapy Arm

EXPERIMENTAL

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 + Chemotherapy + Radiotherapy Arm

EXPERIMENTAL

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

Interventions

Tislelizumab + platinum-based chemotherapy + focal radiotherapy DRUG

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

Tislelizumab + Chemotherapy + Radiotherapy Arm

Tislelizumab + platinum-based chemotherapy DRUG

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

Tislelizumab + Chemotherapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Platinum Compounds

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Central Study Contacts

Jiancheng Li, MD

CONTACT

+86-13906900190; jianchengli6@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 31, 2029
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

CN (1)