招募患者：比较MSC2156119J联合吉非替尼与化疗治疗EGFR突变的MET阳性晚期NSCLC患者的Ib及II期临床试验

2015-09-09 MedSci MedSci原创

1.  试验简介 MSC2156119J是C-MET抑制剂。   2.  试验目的 Ib：确定在MET的晚期NSCLC受试者中，MSC的II 期推荐剂量。 II：在EGFR突变且对吉非替尼一线治疗发生获得耐药性的T790M阴性、MET+局部晚期或转移性NSCLC受试者中，以PFS评价 MSC2156119J联合吉非替尼二线治疗的有效性是否优于培美曲塞+顺铂

1. 试验简介

MSC2156119J是C-MET抑制剂。

2. 试验目的

Ib：确定在MET的晚期NSCLC受试者中，MSC的II 期推荐剂量。 II：在EGFR突变且对吉非替尼一线治疗发生获得耐药性的T790M阴性、MET+局部晚期或转移性NSCLC受试者中，以PFS评价 MSC2156119J联合吉非替尼二线治疗的有效性是否优于培美曲塞+顺铂。

3. 试验设计

试验分类：安全性和有效性

试验分期：其它

设计类型：平行分组（试验组：MSC2156119J+吉非替尼，对照组：培美曲塞+顺铂）

随机化：随机化

盲法：开放

试验范围：国际多中心试验

试验人数：总体151（II）+21（Ib）人，中国87（II)+3（Ib)人

4. 入选标准

1 组织学或细胞学确诊的晚期NSCLC，不考虑组织学亚型，吉非替尼治疗因毒性或依从性以外的原因失败；（Ib）

2 可获得新鲜或存档的治疗前肿瘤组织（不包括细针抽吸和细胞学样本）。对于曾接受过至少一次抗癌治疗的受试者，在最近的抗癌治疗失败与入组之间必须进行一次组织活检（Ib）

3 MET+，由中心实验室确定，如c-Met 过表达，由IHC（如IHC2+或IHC3+）确定和/或c-Met扩增，由ISH 确定（Ib）

4 在任何研究特定的筛选程序前，须获得受试者或法定代理人的签名书面知情同意；

5 男性或女性，年龄≥18 岁（如果当地法律认可的最小年龄大于18 岁时，最小年龄应以当地法律规定为准）。

6 按照RECIST1.1 版，有可测量病灶；

7 东部肿瘤协作组（ECOG）PS 为0 或1。

8 组织学或细胞学确诊的晚期NSCLC，主要组织类型为鳞状细胞的除外；（II）

9 EGFR 受体的活化突变（有文件证明，或由中心实验室确定）；（II）

10 对一线吉非替尼治疗获得性耐药后的EGFR T790M 状态（由中心实验室采用QIAGEN therascreenEGFR RGQ PCR Kit 记录或确定）；（II）

11 对一线吉非替尼治疗 “获得性耐药”，受试者必须满足下文定义的两个标准：a. 随机分组/首次接受试验治疗前4周内一线吉非替尼治疗过程中有疾病进展的放射学资料：i. 在一线吉非替尼治疗时，仅有中枢神经系统（CNS）进展的证据并不认为发生了获得性耐药；ii. 接受一线吉非替尼治疗时有CNS进展和其它全身性进展的证据被认为发生了获得耐药性。如果经手术和/或放射疗法治疗后，CNS病变在不使用类固醇的条件下在随机分组/首次接受试验治疗前4周内稳定至少10天，则受试者有资格入选；b. 既往有客观临床获益，定义为开始一线吉非替尼治疗后部分或完全放射学缓解或持久的SD（> 6个月）；（II）

12 在记录对吉非替尼获得性耐药（在入选标准4 中定义）与入组之间须获得新鲜或存档的肿瘤组织（不包括细针抽吸和细胞学样本）（II）

13 MET+状态，由中心实验室确定，即c-Met 过表达由IHC（如IHC2+或IHC3+）确定和/或c-Met 扩增由ISH 确定（II）

14 适合接受培美曲塞+顺铂的双药化疗。（II）

5. 排除标准

1 脑和/或CNS 症状性转移，采用抗癫痫药物无法控制，需要类固醇，除非在给予首剂试验治疗前4周内接受治疗并且不使用类固醇的情况下疾病稳定至少10 天；

2 既往癌症治疗相关毒性未恢复，且严重程度超过国立癌症研究所不良事件通用术语标准（NCICTCAE）（第4.0 版）2 级；

3 估计的预期寿命<3个月。

4 在首剂试验治疗前14天内需要输血；

5 在首剂试验治疗前21天内曾接受过化疗、生物疗法、放疗或其它试验用抗癌疗法（不包括病灶部位姑息放疗）。

6 血液学功能不足：血红蛋白 <8.5 g/dL;中性粒细胞≤1.5 × 109/L;血小板 < 100 × 109/L；

7 肝功能不足,总胆红素 > 1.5 ×正常上限（ULN）天冬氨酸转氨酶（AST）/丙氨酸转氨酶（ALT）> 3×ULN；对于肝转移受试者：总胆红素 > 1.5 ×ULNAST/ALT > 5 × ULN

8 患有间质性肺病；

9 肾功能不足：根据血清肌酐？ 1.5×ULN 证明的肾损伤，或通过Cockcroft-Gault公式计算肌酐清楚率（CrCl）<60 mL/min（如果计算CrCl<60 mL/min，研究者要求24 小时CrCl 用于证实。这种情况下，应排除24 小时CrCl<60 mL/min 受试者）

10 心脏功能受损按照超声心动图，左心室射血分数（LVEF）< 45%（无充血性心力衰竭[CHF]史时，不要求进行LVEF 评估）;严重心律失常；不稳定型心绞痛；纽约心脏病协会（NYHA）III 和IV 级充血性心力衰竭（附录E）；在进入试验之前的最近12 个月内存在心肌梗死；心包积液；

11 采用标准治疗未得到控制的高血压（血压未稳定在＜150/90 mmHg 以下）；

12 吉非替尼给药的禁忌症；

13 肝纤维化/肝硬化史；

14 既往或目前有NSCLC以外的其它癌症病史，已接受治愈性治疗的非黑色素瘤皮肤癌、原位宫颈癌或其他接受治愈性治疗且至少5 年无复发迹象的癌症除外。

15 存在吞咽困难、吸收障碍或其他慢性胃肠疾病、或可能防碍依从性和/或试验产品吸收的疾病病史;

16 试验治疗第1 天前28 天内进行过重大手术；

17 已知人免疫缺陷病毒阳性；

18 研究者认为可能会使参加研究相关的风险升高的物质滥用、活动性感染、其他急性或慢性身体或精神疾病或者实验室检查异常；

19 妊娠或哺乳的女性受试者，或不愿意或不能在从接受研究药物之前2 周开始一直到接受末次研究药物之后3 个月这一期间内采用高效节育/避孕方法预防怀孕的有生育能力的男性和女性。高效避孕方法是指单独或合并的始终正确使用时失败率低（每年低于1%）的方法。

20 已知对研究药物的任何成分过敏；

21 无法律行为能力或法律行为能力不全；

22 主要研究者认为受试者不适合参加研究。

23 过去30 天内参加过其它临床试验。

24 培美曲塞+顺铂给药的任何禁忌症。（II）

25 使用靶向作用于EGFR通路的化疗或其它药物进行过既往全身性抗癌治疗，不包括用于治疗晚期NSCLC 的吉非替尼（允许（新）辅助治疗目的的一个疗程化疗方案或用于IIIa 阶段疾病一个疗程的化放疗）；（II）

26 既往接受过针对肝细胞生长因子（HGF）/c-Met 通路的其他药物的治疗。（II）

6. 研究者信息

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
2	中国人民解放军307医院	刘晓晴	中国	北京	北京
3	首都医科大学附属北京胸科医院	刘喆	中国	北京	北京
4	上海胸科医院	陆舜	中国	上海	上海
5	南京军区福州总医院	欧阳学农	中国	福建	福州
6	浙江大学附属邵逸夫医院	潘宏铭	中国	浙江	杭州
7	北京协和医院	王孟昭	中国	北京	北京
8	华中科技大学同济医学院附属同济医院	于世英	中国	湖北	武汉
9	四川省肿瘤医院	余萍	中国	四川	成都
10	中国人民解放军第四军医大学唐都医院	张贺龙	中国	陕西	西安
11	浙江省肿瘤医院	张沂平	中国	浙江	杭州
12	大连医科大学附属第二医院	张阳	中国	辽宁	大连
13	第三军医大学附属第一医院	周向东	中国	重庆	重庆
14	北京肿瘤医院	方健	中国	北京	北京
15	吉林大学第一医院	李薇	中国	吉林	长春
16	浙江大学医学院附属第一医院	周建英	中国	浙江	杭州
41	北京肿瘤医院	王洁	中国	北京	北京
42	吉林省肿瘤医院	程颖	中国	吉林	长春

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createdTime=Fri Sep 11 13:30:00 CST 2015, time=2015-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416262, encodeId=01a21416262f1, content=<a href='/topic/show?id=6cef59801ea' target=_blank style='color:#2F92EE;'>#晚期NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59801, encryptionId=6cef59801ea, topicName=晚期NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b093156350, createdName=经常头晕, createdTime=Fri Sep 11 13:30:00 CST 2015, time=2015-09-11, status=1, ipAttribution=)]
2015-12-30 kksonne

#II期临床试验#

87 0
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2016-04-23 FukaiBao

#MSC2156119J#

56 0
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2016-02-04 jklm09

#SCLC患者#

59 0
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2016-04-10 一闲

#MET#

56 0
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createdTime=Fri Sep 11 13:30:00 CST 2015, time=2015-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416262, encodeId=01a21416262f1, content=<a href='/topic/show?id=6cef59801ea' target=_blank style='color:#2F92EE;'>#晚期NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59801, encryptionId=6cef59801ea, topicName=晚期NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b093156350, createdName=经常头晕, createdTime=Fri Sep 11 13:30:00 CST 2015, time=2015-09-11, status=1, ipAttribution=)]
2016-06-05 839640778

#I期临床试验#

0 0
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2016-06-16 医生2402

#I期临床#

93 0
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2015-09-11 huanbaofeng

#MSC#

57 0
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createdTime=Fri Sep 11 13:30:00 CST 2015, time=2015-09-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416262, encodeId=01a21416262f1, content=<a href='/topic/show?id=6cef59801ea' target=_blank style='color:#2F92EE;'>#晚期NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=60, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59801, encryptionId=6cef59801ea, topicName=晚期NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b093156350, createdName=经常头晕, createdTime=Fri Sep 11 13:30:00 CST 2015, time=2015-09-11, status=1, ipAttribution=)]
2015-09-11 xiongliangxl

#NSCLC患者#

49 0
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2015-09-11 经常头晕

#晚期NSCLC#

60 0

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