A Single-arm, Multicenter, and Phase II Clinical Study to Evaluate the Efficacy and Safety of Serplulimab Combined With Chemotherapy in Neoadjuvant and Adjuvant Treatment of Resectable Stage II-IIIA NSCLC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of Major Pathologic Response (MPR)
研究概览
简要总结
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1013. The purpose of this neoadjuvant and adjuvant study is to evaluate the efficacy and safety of Serplulimab and chemotherapy in treating resectable Non-Small Cell Lung Cancer(NSCLC). The study also intended to explore the immune function of tumor-draining lymph nodes during immunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue.
- •Able and willing to give written informed consent and has signed the informed consent form (ICF), prior to performance of any trial activities.
- •Eligible male and female subjects aged 18-75 years.
- •Lung function capacity capable of tolerating the proposed lung surgery.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-
- •Available tissue of primary lung tumor.
排除标准
- •Presence of locally advanced, inoperable or metastatic disease.
- •Subjects with EGFR mutation or ALK、ROS1 gene rearrangement.
- •Active, known or suspected autoimmune disease.
- •Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors).
- •Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Serplulimab plus platinum doublet chemotherapy
干预措施: Serplulimab and Chemotherapy (Drug)
结局指标
主要结局
Rate of Major Pathologic Response (MPR)
时间窗: Up to 6 months
Major pathologic response (MPR) rate is defined as after neoadjuvant treatment, the percentage of residual tumor cells in the tumor bed ≤ 10%, regardless of the proportion of patients with residual tumor cells in lymph nodes
次要结局
- Immune infiltrations in tumor-draining lymph nodes(2 years)
- Rate of R0 resection(Up to 6 months)
- Rate of Pathologic Complete Response (pCR)(Up to 6 months)
- Event-Free Survival (EFS)(2 years)
- Objective remission rate(ORR)(Up to 6 months)
研究者
Haiquan Chen
Director of Thoracic Surgery, Fudan University Shanghai Cancer Center
Fudan University