NCT04144582已完成2 期
Multiple-center, Single-arm, Phase II Study on Sintilimab Combined With Docetaxel in Non-driver Gene Mutation Advanced NSCLC Patients Who Had Failed With Double Platinum-based Chemotherapy
Yongchang Zhang2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy
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
- •Life expectancy exceeds 3 months
- •The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.
排除标准
- •small cell lung cancer or small cell lung cancer
- •Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
- •Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);
研究组 & 干预措施
Sintilimab Combined With Docetaxel
Experimental
Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer
干预措施: Sintilimab Combined With Docetaxel Monotherapy (Drug)
结局指标
主要结局
ORR
时间窗: Approximately 1 years
To measure the patients's overall response rate
次要结局
- PFS(Approximately 1 years)
- OS(Approximately 1 years)
研究者
Yongchang Zhang
Professor
Hunan Province Tumor Hospital
研究点 (2)
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