A Randomized, Open-label, Multicenter Phase II Clinical Trial Evaluating the Efficacy and Safety of Serplulimab Combined With Chemotherapy Versus Nivolumab Combined With Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIa Squamous NSCLC.
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Pathological complete remission (PCR) rate
概览
简要总结
This trial is a randomized, controlled, multicenter, open-label study, planning to enroll 116 subjects with resectable stage II-IIIa squamous NSCLC confirmed by histopathology or cytology, aiming to evaluate the efficacy and safety of serplulimab compared to nivolumab combined with chemotherapy in neoadjuvant therapy. This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1036.
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
- •Age ≥ 18 years and ≤ 75 years at time of study entry.
- •The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology.
- •The patient with stage II-IIIA squamous non-small cell lung cancer confirmed by histopathology or cytology;
- •Able to tolerate complete lung cancer resection;
- •WHO/ECOG performance status of 0 or 1.
排除标准
- •Other pathological histological types of non-small cell lung cancer subjects, including adenocarcinoma subjects, squamous-adenocarcinoma mixed cancer subjects, and NSCLC containing components of small cell lung cancer and neuroendocrine carcinoma.
- •EGFR sensitivity mutation or ALK, ROS1 gene rearrangement;
- •Known severe allergy to any components of carboplatin/albumin paclitaxel and other drugs;
- •Central nervous system (CNS) or leptomeningeal metastases confirmed by imaging or pathology
研究组 & 干预措施
Serplulimab + chemotherapy
Serplulimab injection [300 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles;
干预措施: Serplulimab + chemotherapy (Drug)
Nivolumab + chemotherapy
Nivolumab [360 mg, administered on Day 1, Q3W (once every 3 weeks)] + paclitaxel (albumin-bound) for injection [260 mg/m2, highest dose Not More Than 400 mg, administered on Day 1, Q3W] + carboplatin injection (AUC=5, highest dose Not More Than 750 mg, administered on Day 1, Q3W) for 2-3 cycles;
干预措施: Nivolumab + chemotherapy (Drug)
结局指标
主要结局
Pathological complete remission (PCR) rate
时间窗: From randomization up to a median of 30 months after randomization
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by investigator.
次要结局
未报告次要终点