NCT04951947招募中2 期
A Prospective, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of JS-201 Combined With Lenvatinib in the Treatment of Small-cell Lung Cancer With Previous Chemotherapy Combined With PD-L1 Failure
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is a prospective, single-arm phase II clinical study to evaluate the efficacy and safety of JS-201 combined with lenvatinib in the treatment of small-cell lung cancer that has failed previous chemotherapy combined with PD-L1. The primary observational endpoint is ORR, and the secondary observational endpoint is PFS, OS. The intervention mode is JS201 300mg i.v Q2w, lenvatinib 8mg po. Qd.
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
- •The imaging diagnosis is the extensive stage of SCLC
- •The patient failed first-line EC+PD-L1 treatment
排除标准
- •Diagnosed as non-small cell lung cancer
- •Women during pregnancy
- •Patients with symptomatic brain metastases
研究组 & 干预措施
Arm A
Experimental
Treatment arm
干预措施: JS201 combine with Lenvatinib (Drug)
结局指标
主要结局
ORR
时间窗: 1 year
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
次要结局
- PFS(1 year)
研究者
Yongchang Zhang
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor
Hunan Province Tumor Hospital
研究点 (1)
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