SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer: A Randomized, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 84
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male or female.
- •Baseline ECOG performance status 0-
- •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
排除标准
- •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