About this 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.
Eligibility criteria
Qualifiers
Age ≥18 years, male or female.
Baseline ECOG performance status 0-1.
Histologically or cytologically confirmed unresectable stage III NSCLC
Life expectancy ≥3 months
Disqualifiers
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
Trial design
Treatments tested in this trial
- SHR-1701 combined with platinum-doublet chemotherapy induction therapy
- SHR-1701 consolidation therapy
- Platinum-doublet chemotherapy
- radiotherapy
Treatment groups
Locations
Sponsors and collaborators
Fudan University
Lead sponsor