Neoadjuvant Sintilimab and Platinum-based Chemotherapy for Resectable Locally Advanced NSCLC Harboring no Driver Mutations: A Prospective, Randomized, Multicenter Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pathologically complete response (pCR) rate
研究概览
简要总结
This is a randomized, open-label study designed to evaluate the safety and efficacy of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA non-small cell lung cancer.
The primary endpoint: pCR rate The second endpoint: MPR, DFS, MRD
详细描述
This study is a prospective, multicenter, phase III randomized controlled clinical study. Stage IIIA NSCLC patients with EGFR mutation negative and ALK rearrangement negative were enrolled, and after 2 courses of treatment with Sintilimab combined with Platinum-based Chemotherapy, they were randomly assigned 1:1 to the control group (surgical resection and postoperative treatment for 2 courses are recommended) or the experimental group (surgery after 2 courses of treatment).
The primary endpoint is pCR rate. The second endpoints are MPR, DFS, and MRD.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resectable stage IIIA NSCLC, EGFR mutation-negative and ALK rearrangement negative (8th UICC TNM staging);
- •No prior anti-tumor therapy for NSCLC;
- •Age from 18 to 75 years old;
- •Adequate organ function:
- •Hemoglobin ≥9.0g/L; White blood cell count 4.0~10×109/L; The absolute value of neutrophils (ANC) ≥ 1.5×109/L; Platelet count ≥100×109/L; Total bilirubin ≤ 1.5 times the upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; The international normalized ratio of prothrombin time is ≤1.5 times the upper limit of normal value, and the partial thromboplastin time is within the range of normal value; Creatinine ≤ 1.5 times the upper limit of normal;
- •No chemotherapy, radiotherapy or hormone therapy for malignant tumors, no history of other malignant tumors, excluding patients who have received hormone therapy for prostate cancer and have had DFS for more than 5 years;
排除标准
- •Double primary or multiple primary NSCLC;
- •EGFR mutation or ALK mutation was positive
- •patients with psychosis;
- •Pre-existing or coexisting bleeding disorders;
- •Other uncontrollable and inoperable patients;
- •Patients whose previous operations have prevented this operation from being performed;
- •Female patients who are pregnant or breastfeeding;
- •For patients who are allergic to the drugs in the program.
研究组 & 干预措施
Control group
Neoadjuvant therapy of Sintilimab and chemotherapy in 2 cycles before surgery and optional adjuvant therapy of Sintilimab and chemotherapy in 2 cycles after surgery
干预措施: PD-1 and chemotherapy (Drug)
Experimental group
Neoadjuvant therapy of Sintilimab and chemotherapy in 4 cycles before surgery
干预措施: PD-1 and chemotherapy (Drug)
结局指标
主要结局
Pathologically complete response (pCR) rate
时间窗: in three weeks after the surgical resection
次要结局
- Major pathological response (MPR) rate(in three weeks after the surgical resection)
- Disease-free survival (DFS)(one, two, three and five years since the initial treatment (each treatment is 2 days))
- Minimal residual disease(MRD)(in one week before each cycle and in the forth week after the surgical resection (each cycle is 21 days))
研究者
Jiang Fan
Director of Department of Thoracic Surgery
Tongji University