Keytruda中国临床试验招募患者：非小细胞肺癌

2017-06-02 佚名药时代

ganzhu

南充东方医院医生/ 主治医师

Keytruda中国临床试验招募患者

肿瘤免疫疗法药物Keytruda（pembrolizumab，MK-3475）成为5个获批的抗PD-1/PD-L1单抗药物中最引人注目的。

我们检索了中国药物临床试验登记与信息公示平台，汇总该药物在中国的临床试验的进展状态。如下表所示，共有8项临床试验，其中进行中尚未招募的2项，进行中招募中的6项。

今天分享的是：CTR20160205，含铂药物全身治疗后出现疾病进展且肿瘤PD-L1表达呈阳性的非小细胞肺癌（NSCLC）。

题目和背景信息：

试验目的：

在肿瘤PD-L1表达呈阳性且在至少一次含铂系统治疗后发生疾病进展的NSCLC受试者中评价pembrolizumab（MK-3475）与多西他赛治疗相比的OS， PFS，ORR，DOR以及安全性和耐受性

试验设计：

试验分类：安全性和有效性
试验分期：III期
设计类型：平行分组
随机化：随机化
盲法：开放
试验范围：国际多中心

受试者信息：

年龄： 18岁(最小年龄)至无岁(最大年龄)
性别：男+女
健康受试者：无
入选标准：15 项
排除标准：20 项
目标入组人数：国际多中心试验：总体740人，中国600人；
实际入组人数：登记人暂未填写该信息

第一例受试者入组日期：

2016-09-08 国内

主要研究者信息：

重要声明：

以上信息仅供个人参考。欲了解详情，请登录中国药物临床试验登记与信息公示平台。衷心感谢！

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评论区 (4)

#插入话题

插入图片

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2017-12-20 121198adm92暂无昵称

不知道招募截止到什么时候?

100 0
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2018-04-22 lingaifan

#非小细胞#

67 0
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2017-07-01 lyh994

多一些这样的信息，可以影响更多的人

98 0
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2017-06-03 ms1260584454294838

#招募#

64 0

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