ASCO 2014：MSC2156119J+吉非替尼治疗MET阳性EGFR突变晚期NSCLC的I/II期临床试验

2014-05-31 李文丰译医学论坛网

摘要号：TPS8121 第一作者：吴一龙，广东省人民医院标题：c-Met抑制剂MSC2156119J+吉非替尼或化疗，二线治疗MET阳性局部晚期或远处转移的EGFR突变NSCLC患者治疗的多中心、随机、开放标签的I/II期临床试验。背景：EGFR突变NSCLC患者对EGFR-TKIs（比如吉非替尼）抵抗的主要原因是EGFR基因再次发生突变（比如T790M）

摘要号：TPS8121

第一作者：吴一龙，广东省人民医院

标题：c-Met抑制剂MSC2156119J+吉非替尼或化疗，二线治疗MET阳性局部晚期或远处转移的EGFR突变NSCLC患者治疗的多中心、随机、开放标签的I/II期临床试验。

背景：EGFR突变NSCLC患者对EGFR-TKIs（比如吉非替尼）抵抗的主要原因是EGFR基因再次发生突变（比如T790M）或者c-Met/HGF信号通路的激活（蛋白过度表达和/或扩大）。MSC2156119J是一种高选择性小分子c-Met抑制剂，在一项治疗晚期实体瘤患者的I期临床试验中（Falchook等人.J Clin Oncol 2013:31（Suppl）：2506），该药显示出有前途的抗肿瘤活性。在这个多中心、开放标签的Ib/II期临床试验中，我们评估了MSC2156119J+吉非替尼在MET阳性的晚期EGFR突变非小细胞肺癌（NSCLC）患者中的抗肿瘤活性。

方法：主要目标是确定联合治疗方案的推荐的二期剂量（RP2D）（1b期）和研究者读取的无进展生存期（PFS）（2期）。次要目标包括安全性、药物代谢动力学、MSC2156119J的抗肿瘤活性（由独立研究者读取PFS，总存活数，客观反应率和疾病控制程度）。从中国大陆、南韩、中国台湾和其他亚洲国家招募EGFR突变、ECOG体能评分0-1级和对一线药物吉非替尼抵抗的NSCLC成人患者（仅用于二期）。确认患者MET表达阳性，当免疫组化显示蛋白过度表达或原位杂交MET基因增殖时，则定义为强阳性或中等强度阳性。

主要排除标准：生命期望值<3个月，或之前接受了吉非替尼以外的EGFR靶点治疗（仅用于二期）。对于Ib期阶段（3+3设计的队列研究），纳入15-18个患者，计划口服300mg或500mgMSC2156119J+口服250mg/d吉非替尼（21天/周期）；II期阶段，计划招募200个患者以上，根据他们的T790M状态进入2个预设亚组，随后按照1:1比例分配到推荐的二期剂量（RP2D）MSC2156119J口服+250mg/d吉非替尼口服或 500mg/m2培美曲塞静脉注射+75mg/m2顺铂静脉注射（第1天）（最多6个周期，21天/周期）Ib期开始招募的时间是2013年10月23日。

研究链接：Phase I/II multicenter, randomized, open-label trial of the c-Met inhibitor MSC2156119J and gefitinib versus chemotherapy as second-line treatment in patients with MET-positive (MET+), locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor mutation (EGFRm+) and progression on gefitinib. (Abstract TPS8121)

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2015-04-01 FukaiBao

#MSC2156119J#

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2014-11-26 一闲

#MET#

22 0
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2014-08-10 kksonne

#II期临床试验#

33 0
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encryptionId=5b011018e07, topicName=I期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fc1f24335670, createdName=医生2402, createdTime=Thu Aug 07 13:41:00 CST 2014, time=2014-08-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088666, encodeId=73b5208866614, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, createdName=839640778, createdTime=Sun Dec 07 09:41:00 CST 2014, time=2014-12-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1938337, encodeId=0f57193833efb, content=<a href='/topic/show?id=1c292818fd' target=_blank style='color:#2F92EE;'>#ASC#</a>, beContent=null, objectType=article, 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2014-08-07 医生2402

#I期临床#

18 0
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channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sun Apr 05 15:41:00 CST 2015, time=2015-04-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406674, encodeId=273214066e4f6, content=<a href='/topic/show?id=099d122e1cd' target=_blank style='color:#2F92EE;'>#MSC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12271, encryptionId=099d122e1cd, topicName=MSC)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83epVh4QoCj2A7xBBEjh8q7ia2BsLkylnuQ15ia2MDzvr28XR0CVvBPpFXTlB1mprG7WgBb06gvn4Eia5Q/132, createdBy=55e02571190, createdName=huanbaofeng, createdTime=Mon Jun 02 12:41:00 CST 2014, 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2014-12-07 839640778

#I期临床试验#

39 0
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channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sun Apr 05 15:41:00 CST 2015, time=2015-04-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406674, encodeId=273214066e4f6, content=<a href='/topic/show?id=099d122e1cd' target=_blank style='color:#2F92EE;'>#MSC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12271, encryptionId=099d122e1cd, topicName=MSC)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83epVh4QoCj2A7xBBEjh8q7ia2BsLkylnuQ15ia2MDzvr28XR0CVvBPpFXTlB1mprG7WgBb06gvn4Eia5Q/132, createdBy=55e02571190, createdName=huanbaofeng, createdTime=Mon Jun 02 12:41:00 CST 2014, time=2014-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416256, encodeId=3dd514162563e, 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=25, 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=Mon Jun 02 12:41:00 CST 2014, time=2014-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524546, encodeId=a68a1524546d4, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Mon Jun 02 12:41:00 CST 2014, time=2014-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534239, encodeId=f631153423963, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Mon Jun 02 12:41:00 CST 2014, time=2014-06-02, status=1, ipAttribution=)]
2015-04-05 quxin068

#ASC#

27 0
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2014-06-02 huanbaofeng

#MSC#

28 0
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2014-06-02 经常头晕

#晚期NSCLC#

25 0
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2014-06-02 guihongzh

#II期临床#

21 0
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channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2818, encryptionId=1c292818fd, topicName=ASC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Sun Apr 05 15:41:00 CST 2015, time=2015-04-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1406674, encodeId=273214066e4f6, content=<a href='/topic/show?id=099d122e1cd' target=_blank style='color:#2F92EE;'>#MSC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12271, encryptionId=099d122e1cd, topicName=MSC)], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83epVh4QoCj2A7xBBEjh8q7ia2BsLkylnuQ15ia2MDzvr28XR0CVvBPpFXTlB1mprG7WgBb06gvn4Eia5Q/132, createdBy=55e02571190, createdName=huanbaofeng, createdTime=Mon Jun 02 12:41:00 CST 2014, time=2014-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416256, encodeId=3dd514162563e, 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=25, 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=Mon Jun 02 12:41:00 CST 2014, time=2014-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1524546, encodeId=a68a1524546d4, content=<a href='/topic/show?id=4ba395994d' target=_blank style='color:#2F92EE;'>#II期临床#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9599, encryptionId=4ba395994d, topicName=II期临床)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=139811614978, createdName=guihongzh, createdTime=Mon Jun 02 12:41:00 CST 2014, time=2014-06-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1534239, encodeId=f631153423963, content=<a href='/topic/show?id=22b3e9887e' target=_blank style='color:#2F92EE;'>#GFR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=19, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7988, encryptionId=22b3e9887e, topicName=GFR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0a812532020, createdName=liuyiping, createdTime=Mon Jun 02 12:41:00 CST 2014, time=2014-06-02, status=1, ipAttribution=)]
2014-06-02 liuyiping

#GFR#

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