Open-Label, Randomized, Phase III Clinical Study Comparing the Pharmacokinetic Profile, Efficacy, and Safety of JS001sc and JS001 in Combination With Standard Chemotherapy as First-Line Treatment for Recurrent Metastatic Non-Squamous Non Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Observed serum Ctrough at Cycle 1
研究概览
简要总结
This is a multicenter, open-Lable, randomized, phase III clinical study to compare the pharmacokinetic profile, efficacy, and safety of Toripalimab injection (subcutaneous) (JS001sc) and Toripalimab injection (JS001) in combination with standard chemotherapy as first-line treatment for recurrent or metastatic Non-Squamous Non small cell lung cancer
详细描述
This study adopted a randomized, open-label, positive control, multicenter, phase III clinical research design. It selected patients with recurrent or metastatic non-squamous NSCLC who did not have sensitive EGFR mutations or ALK fusions. A total of 356 patients (increased to 395 according to the recommendation of the Data Monitoring Committee) were planned to be enrolled. They would be randomly assigned to one of the following two treatment groups at a ratio of 1:1:
Group A: JS001sc+ platinum-based chemotherapy
JS001sc, 360 mg, was administered subcutaneously (SC) once every 3 weeks (Q3W).
Chemotherapy: pemetrexed + carboplatin/cisplatin, Q3W, up to 4 cycles, non-progressive subjects pemetrexed monotherapy maintenance therapy.
Group B: JS001+ platinum-based chemotherapy
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
盲法说明
No Masking
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm1:JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy
干预措施: JS001sc (360mg Subcutaneous injection) and pemetrexed/platinum-containing chemotherapy (Drug)
Arm 2:JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy
干预措施: JS001 (240mg intravenous infusion) and pemetrexed/platinum-containing chemotherapy (Drug)
结局指标
主要结局
Observed serum Ctrough at Cycle 1
时间窗: the end of Cycle 1 (Each cycle is 21 days)
Measured valley concentration at the end of cycle 1 (Ctrough)
Model-predicted area under the concentration-time curve(AUC) from 0 to 21 days at Cycle 1
时间窗: the end of Cycle 1 (Each cycle is 21 days)
The area under the drug time curve of cycle 1 simulated by a population pharmacokinetic model
次要结局
- Disease control rate (DCR)(up to 2years)
- Safety: adverse events (AEs)(up to 2years)
- Progression-free survival (PFS)(up to 2years)
- Duration of response (DoR)(up to 2years)
- Objective response rate (ORR)(up to 2years)
- 6-month progression-free survival(PFS) rate(up to 6-month)