NCT05296603招募中2 期
Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer Who Failed From First Line PD-(L)-1 Inhibitors: Multiple Cohorts Perspective Study
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年12月3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
- 83
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This study aimed to explore the efficacy and biomarker explanation of IBI-322 Plus Lenvatinib on extensive stage small cell lung cancer who failed from first line PD-(L)1 inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（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
- •Patients with contraindication of chemotherapy Pregnant or breast feeding women
研究组 & 干预措施
Cohort A
Experimental
Duration of response time less than 3 months
干预措施: IBI-322 Plus Lenvatinib (Drug)
Cohort B
Experimental
Duration of response time between 3 and 6 months
干预措施: IBI-322 Plus Lenvatinib (Drug)
Cohort C
Experimental
Duration of response time more than 6 months
干预措施: IBI-322 Plus Lenvatinib (Drug)
结局指标
主要结局
ORR
时间窗: 12 weeks
Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects
次要结局
- PFS(1year)
- OS(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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