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NOT YET RECRUITING
NCT07619911
PHASE2

SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This randomized phase II exploratory clinical study aims to evaluate the efficacy and safety of SHR-1701 in patients with unresectable stage III non-small cell lung cancer (NSCLC). A total of 84 eligible patients will be randomized 1:1 into an induction immunotherapy group or a consolidation immunotherapy group. Group A will receive SHR-1701 combined with platinum-based chemotherapy as induction therapy followed by concurrent chemoradiotherapy (cCRT) and subsequent SHR-1701 consolidation therapy, while Group B will receive standard cCRT followed by SHR-1701 consolidation therapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety outcomes.

Official title: SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer: A Randomized, Phase II Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2026-07

Completion Date

2030-12

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

SHR-1701 combined with platinum-doublet chemotherapy induction therapy

SHR-1701 combined with platinum-doublet chemotherapy induction therapy

DRUG

SHR-1701 consolidation therapy

SHR-1701 consolidation therapy

DRUG

Platinum-doublet chemotherapy

Platinum-doublet chemotherapy

RADIATION

radiotherapy

Thoracic concurrent radiotherapy, total dose 60 Gy ±10%