患者招募：恒瑞PD-L1药物SHR-1316或安慰剂联合化疗围手术期治疗非小细胞肺癌临床研究

2020-04-20 chinadrugtrials chinadrugtrials

SHR-1316或安慰剂联合化疗围手术期治疗非小细胞肺癌临床研究

SHR-1316或安慰剂联合化疗围手术期治疗非小细胞肺癌临床研究

一、题目和背景信息

登记号：	CTR20200587
适应症：	可切除非小细胞肺癌围手术期治疗
试验通俗题目：	SHR-1316或安慰剂联合化疗围手术期治疗非小细胞肺癌临床研究
试验专业题目：	SHR-1316或安慰剂联合化疗作为可切除非小细胞肺癌围手术期治疗的随机、双盲、多中心IB/III期临床研究
试验方案编号：	SHR-1316-III-303；2.0
临床申请受理号：	企业选择不公示
药物名称：	SHR-1316注射液
药物类型：	生物制品

二、申办者信息

申办者名称：

1	江苏恒瑞医药股份有限公司/
2	上海恒瑞医药有限公司/

联系人姓名：

许科科

联系人电话：

400-828-3900

联系人Email：

xukeke@hrglobe.cn

联系人邮政地址：

广州市天河区华夏路16号富力盈凯大厦2503

联系人邮编：

510000

试验项目经费来源：

完全自筹

三、临床试验信息

1、试验目的

比较SHR-1316或安慰剂联合化疗作为可切除非小细胞肺癌新辅助治疗的主要病理学缓解率。比较SHR-1316或安慰剂联合化疗作为可切除非小细胞肺癌围手术期治疗的无事件生存时间。

2、试验设计（单选）

	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：	双盲
	试验范围：	国内试验

3、受试者信息

年龄

18岁(最小年龄)至 70岁(最大年龄)

性别

男+女

健康受试者

无

入选标准

1	以治愈为目的的可手术切除的非小细胞肺癌患者
2	年龄：≥18岁，≤70岁，男女均可。
3	ECOG评分0或1分
4	主要脏器功能正常。
5	至少具有1个符合RECIST 1.1标准的可测量病灶。

排除标准

1	有恶性胸腔积液
2	既往接受过针对非小细胞肺癌的系统性抗肿瘤治疗
3	既往曾接受过胸部放疗的受试者
4	人类免疫缺陷病毒（HIV）感染或已知有获得性免疫缺陷综合征（艾滋病），活动性乙肝或丙肝。
5	筛查前5年内具有除非小细胞肺癌以外的其他恶性肿瘤
6	已知或可疑有间质性肺炎的受试者；其他可能会干扰药物相关肺毒性的检测或处理的、严重影响呼吸功能的中重度肺部疾病
7	患有严重的心脑血管疾病的受试者

目标入组人数

国内试验:486人;

实际入组人数

登记人暂未填写该信息

4、试验分组

试验药

序号	名称	用法
1	注射用SHR-1316	注射剂，规格600mg/12ml,静脉注射给药,每3周进行一次给药。
2	注射用卡铂，英文名：Caborplatin for Injection，商品名：卡铂	注射剂，规格0.1g/支，静脉注射，每3周进行一次给药。
3	注射用紫杉醇（白蛋白结合型），英文名：Paclitaxel for Injection（Albumin Bound），商品名：艾越	注射剂，规格：100mg/支，静脉注射，每周一次给药。

对照药

序号	名称	用法
1	SHR-1316注射液安慰剂	注射剂(成分：20mM琥珀酸，60g/L蔗糖，0.6g/L 聚山梨酯80)，规格600mg/12ml每瓶 ,静脉注射给药,每3周进行一次给药。

5、终点指标

主要终点指标及评价时间

序号	指标	评价时间	终点指标选择
1	MPR和EFS	研究期间	有效性指标

次要终点指标及评价时间

序号	指标	评价时间	终点指标选择
1	不良事件	研究期间	安全性指标
2	手术切除率和手术并发症评估	研究期间	安全性指标

6、数据安全监察委员会（DMC）：无

7、为受试者购买试验伤害保险：有

四、第一例受试者入组日期

登记人暂未填写该信息

五、试验终止日期

登记人暂未填写该信息

六、研究者信息

1、主要研究者信息

姓名	吴一龙，医学博士	职称	副院长;教授
电话	020-83827812-21187	Email	syylwu@live.cn
邮政地址	广东省广州市越秀区中山二路106号	邮编	510060
单位名称	广东省人民医院

2、各参加机构信息

序号	机构名称	主要研究者	国家	省（州）	城市
1	广东省人民医院	吴一龙	中国	广东	广州

七、伦理委员会信息

序号	名称	审查结论	审查日期
1	广东省人民医院医学伦理委员会	同意	2020-03-09

八、试验状态

进行中（尚未招募）

SHR-1316介绍：

SHR-1316 注射液是恒瑞医药自主研发的一种人源化抗 PD-L1 单克隆抗体，主要用于恶性肿瘤的治疗。目前国外有同类产品 Atezolizumab（商品名 Tecentriq）、Avelumab(商品名 Bavencio)和 Durvalumab(商品名Imfinzi)于美国获批上市销售

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2020-06-18 lingaifan

#非小细胞#

37 0
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2020-05-06 ms3117646317107274

#手术期#

32 0
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2020-08-15 lixiao3326

#SHR-1316#

39 0
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2020-04-22 smartjoy

#PD-L1#

36 0
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2020-04-22 wleon8895

#安慰剂#

30 0
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2020-04-22 oliver170

#联合化疗#

32 0
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2020-04-22 ms1260584454294838

#招募#

38 0

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患者招募：恒瑞PD-L1药物SHR-1316或安慰剂联合化疗围手术期治疗非小细胞肺癌临床研究

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