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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
SHR-1701 combined with platinum-doublet chemotherapy induction therapy
SHR-1701 consolidation therapy
Platinum-doublet chemotherapy
Thoracic concurrent radiotherapy, total dose 60 Gy ±10%
Progression-Free Survival (PFS)
Time frame: 4 years
Objective Response Rate (ORR)
Time frame: 4 years
Disease Control Rate (DCR)
Time frame: 4 years
Overall Survival (OS)
Time frame: 4 years
Treatment-Related Adverse Events (TRAE)
Time frame: 4 years
Serious Adverse Events (SAE)
Time frame: 4 years
Treatment-Emergent Adverse Events (TEAE)
Time frame: 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.