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SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer
Sponsor: Fudan University
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
Conditions
Interventions
SHR-1701 combined with platinum-doublet chemotherapy induction therapy
SHR-1701 combined with platinum-doublet chemotherapy induction therapy
SHR-1701 consolidation therapy
SHR-1701 consolidation therapy
Platinum-doublet chemotherapy
Platinum-doublet chemotherapy
radiotherapy
Thoracic concurrent radiotherapy, total dose 60 Gy ±10%