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NOT YET RECRUITING
NCT07874464
PHASE2

Prospective Phase II Study of Concurrent Radiotherapy Combined With Full-Course Immunotherapy or Consolidation Immunotherapy for Locally Advanced NSCLC

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective, randomized phase II study evaluating concurrent chemoradiotherapy combined with full-course immunotherapy or consolidative immunotherapy in patients with unresectable, locally advanced non-small cell lung cancer.

Official title: A Prospective Phase II Study to Evaluate Concurrent Radiotherapy Combined With Full-course Immunotherapy or Concurrent Radiotherapy Combined With Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2026-10-12

Completion Date

2029-10-12

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DRUG

Induction chemoimmunotherapy

Nab-paclitaxel 260 mg/m² + cisplatin 75 mg/m² + tislelizumab 200 mg on day 1, Q3W,3 cycles.

RADIATION

radiotherapy

Thoracic radiotherapy at a definitive dose using intensity-modulated radiation therapy or Volumetric Modulated Arc Therapy.

DRUG

Concurrent Chemotherapy

Nab-paclitaxel 50 mg/m² + cisplatin 25 mg/m² on day 1, weekly.

DRUG

consolidation immunotherapy

Tislelizumab 200 mg on day 1, every 3 weeks.

DRUG

full-course immunotherapy

Immunotherapy (Tislelizumab 200 mg d1) will be administered during the concurrent chemoradiotherapy phase and consolidation phase, but not on radiotherapy days.

Locations (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China