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

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

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.

Inclusion Criteria:

• Age ≥18 years, male or female.
• Baseline ECOG performance status 0-1.
• Histologically or cytologically confirmed unresectable stage III NSCLC
• Life expectancy ≥3 months
• No prior anti-tumor therapy
• No known EGFR/ALK/ROS1 sensitive mutations
• At least one measurable lesion according to RECIST v1.1
• Adequate organ function
• Signed informed consent

Exclusion Criteria:

• Mixed small-cell and non-small-cell lung cancer histology
• Known EGFR/ALK/ROS1 mutations
• Prior systemic anti-cancer therapy within 4 weeks
• Active autoimmune disease requiring systemic treatment
• Active infection including uncontrolled HBV, HCV or HIV infection
• Significant cardiovascular disease
• Uncontrolled hypertension
• Pregnancy or breastfeeding
• Participation in another interventional clinical trial