上海注射用MK-6070II期临床试验-MK-6070联合Ifinatamab Deruxtecan（MK-2400）用于一线广泛期小细胞肺癌的研究

登记号	CTR20255221	试验状态	进行中
申请人联系人	曹媛媛	首次公示信息日期	2025-12-31
申请人名称	Merck Sharp & Dohme LLC/ 默沙东研发（中国）有限公司/ Vetter Development Services USA, Inc.

登记号	CTR20255221
相关登记号	暂无
药物名称	注射用MK-6070
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	一线广泛期小细胞肺癌
试验专业题目	一项评估MK-6070和Ifinatamab Deruxtecan（MK-2400）基于不同给药方案用于一线广泛期小细胞肺癌的Ib/II期开放标签研究
试验通俗题目	MK-6070联合Ifinatamab Deruxtecan（MK-2400）用于一线广泛期小细胞肺癌的研究
试验方案编号	MK-6070-003	方案最新版本号	00
版本日期:	2025-08-08	方案是否为联合用药	是

申请人名称	[["Merck Sharp & Dohme LLC"],["默沙东研发（中国）有限公司"],["Vetter Development Services USA, Inc."]]
联系人姓名	曹媛媛	联系人座机	010-58609841	联系人手机号	18518610287
联系人Email	yuan.yuan.cao@msd.com	联系人邮政地址	北京市-北京市-朝阳区望京研发创新基地容达路21号楼	联系人邮编	100012

一项评估MK-6070和Ifinatamab Deruxtecan（MK-2400）基于不同给药方案用于一线广泛期小细胞肺癌的Ib/II期开放标签研究

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

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["患有经组织学或细胞学确诊的广泛期SCLC（根据AJCC（第9 版）定义为IV期 [任何T、N、M1a/b/c]）"],["性别不限，且提供知情同意书时，年龄≥18岁（含18岁）。如果表示同意参加研究的法定年龄>18岁，请遵守当地法规要求"],["受试者已提供本研究的书面知情同意书"],["由当地研究中心研究者/影像科医师根据RECIST 1.1评估的存可测量病灶"],["入组前，必须有存档肿瘤组织样本或新获得的（既往未接受过放疗的）粗针活检肿瘤病灶供运输"],["分配/随机分组前7天内ECOG体能状态评分为0至1分"],["筛选时充分器官功能"]]
排除标准	[["胸腔积液、心包积液或需要反复引流操作的腹水"],["有需要类固醇治疗的（非感染性）肺部炎症/ILD病史，或当前患有肺部炎症/ILD，和/或筛选时无法通过影像学检查排除疑似ILD/肺部炎症"],["因肺部并发症导致的临床重度肺部病变"],["活动性或有免疫缺陷病史"],["有临床意义的活动性感染，需要系统性治疗"],["同种异体组织/实体器官移植史"],["软脑膜病变"]]

试验药	[["中文通用名:NA 英文通用名:MK-6070(HPN328，DS-3280，gocatamig) 商品名称:NA","剂型:注射剂 规格:1mg/ml 用法用量:36mg 用药时程:每3周一次"],["中文通用名:NA 英文通用名:I-DXd(MK-2400，ifinatamabderuxtecan，DS-7300a) 商品名称:NA","剂型:注射剂 规格:100mg 用法用量:10mg/kg 用药时程:每3周一次"],["中文通用名:阿替利珠单抗 英文通用名:Atezolizumab 商品名称:泰圣奇","剂型:注射剂 规格:1200mg 用法用量:1200mg 用药时程:每3周一次"]] 序号 名称 用法
对照药	[["中文通用名:阿替利珠单抗 英文通用名:Atezolizumab 商品名称:泰圣奇","剂型:注射剂 规格:1200mg 用法用量:1200mg 用药时程:每3周一次"],["中文通用名:卡铂注射液 英文通用名:Carboplatininjection 商品名称:伯尔定","剂型:注射剂 规格:150mg 用法用量:AUC5mg/ml/min 用药时程:每3周一次"],["中文通用名:依托泊苷注射液 英文通用名:Etoposide 商品名称:NA","剂型:注射剂 规格:5ml/100mg 用法用量:100mg/m2 用药时程:每3周一次"]] 序号 名称 用法

主要终点指标及评价时间	[["MK-6070联合I-DXd在不同给药方案下安全性和耐受性","3年","安全性指标"],["BICR根据RECIST 1.1评估MK-6070联合I-DXd在不同给药方案下的客观缓解率（ORR）","3年","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["BICR根据RECIST 1.1评估的MK-6070联合I-DXd在不同给药方案下疾病控制率（DCR）、缓解持续时间（DOR）、无进展生存期（PFS）等","3年","有效性指标"],["MK-6070联合I-DXd在不同给药方案下总生存期（OS）","3年","有效性指标"],["MK-6070联合I-DXd的药代动力学如AUC, Cmax, Ctrough等","3年","安全性指标"],["MK6070和I-Dxd的免疫原性","3年","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	周彩存	学位	博士	职称	主任医师
	电话	021-58822171	Email	CAICUNZHOUDR@TONGJI.EDU.CN	邮政地址	上海市-上海市-浦东新区云台路1800号
	邮编	200120	单位名称	上海市东方医院

[["上海市东方医院","周彩存","中国","上海市","上海市"],["浙江省台州医院","吕冬青","中国","浙江省","台州市"],["浙江大学医学院附属第一医院","周建娅","中国","浙江省","杭州市"],["北京肿瘤医院","卓明磊","中国","北京市","北京市"],["哈尔滨医科大学附属肿瘤医院","于雁","中国","黑龙江省","哈尔滨市"],["福建省肿瘤医院","何志勇","中国","福建省","福州市"],["南方医科大学南方医院","刘来昱","中国","广东省","广州市"],["四川省肿瘤医院","姚文秀","中国","四川省","成都市"],["南昌大学第一附属医院","孙龙华","中国","江西省","南昌市"],["江门市中心医院","黄炎明","中国","广东省","江门市"],["John Theurer Cancer Center at Hackensack University Medical Center","Gutierrez, Martin","美国","Hackensack","Hackensack"],["Avera Cancer Institute- Research","Sanford, Amy","美国","Sioux Falls","Sioux Falls"],["Providence Cancer Institute, Franz Clinic – Eastside","Sanborn, Rachel","美国","Portland","Portland"],["Orlando Health Cancer Institute","Johnson, Tirrell","美国","Orlando","Orlando"],["Saint Elizabeth Medical Center Edgewood","Darnell, Colleen","美国","Edgewood","Edgewood"],["Houston Methodist Hospital - Houston Methodist Neal Cancer Center","Zhang, Jun","美国","Houston","Houston"],["The University of Tennessee Medical Center","Davarifar, Ardy","美国","Knoxville","Knoxville"],["University of Virginia Health System","Gentzler, Ryan","美国","Charlottesville","Charlottesville"],["Providence Medical Foundation","Anderson, Ian","美国","Santa Rosa","Santa Rosa"],["University of Colorado Anschutz Medical Campus","Schenk, Erin","美国","Aurora","Aurora"],["NYU Langone Health","Veluswamy, Rajwanth","美国","New York","New York"],["Lt. Col. Luke Weathers, Jr. VA Medical Center","Weir, Alva","美国","Memphis","Memphis"],["Washington University School of Medicine","Morgensztern, Daniel","美国","St. Louis","St. Louis"],["FALP","Caglevic, Christian","智利","Santiago","Santiago"],["Bradfordhill","Rojas, Carlos","智利","Santiago","Santiago"],["Pontificia Universidad Catolica de Chile","Carrillo, Diego","智利","Santiago","Santiago"],["Hospices Civils de Lyon – Hopital Louis Pradel","Duruisseaux, Michael","法国","Bron","Bron"],["Centre Hospitalier Universitaire de Limoges - H？pital Dupuytren","Egenod, Thomas","法国","Limoges","Limoges"],["CHRU de Brest-Institut de cancérologie et d'Hématologie","NGUYEN, Jessica","法国","Brest","Brest"],["CHU GRENOBLE ALPES","MORO SIBILOT, DENIS","法国","La Tronche","La Tronche"],["Universitaetsklinikum Koeln","Nogova, Lucia","德国","Koln","Koln"],["Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne","Gross, Thorben","德国","Tuebingen","Tuebingen"],["Comprehensive Cancer Center Mainfranken","Hummel, Horst","德国","Würzburg","Würzburg"],["Universitaetsklinikum Jena","Hammersen, Jakob","德国","Jena","Jena"],["European Interbalkan Medical Center","Baka, Sofia","希腊","Thessaloniki","Thessaloniki"],["Errikos Dunant Hospital Center","MOUNTZIOS, IOANNIS","希腊","Athens","Athens"],["THORACIC GENERAL HOSPITAL OF ATHENS","Syrigos, Konstantinos","希腊","Athens","Athens"],["University General Hospital of Heraklion","Mavroudis, Dimitrios","希腊","Heraklion","Heraklion"],["Athens Medical Center","Ramfidis, Vasileios","希腊","Athens","Athens"],["European Interbalkan Medical Center","Korantzis, Ippokratis","希腊","Thessaloniki","Thessaloniki"],["Sheba Medical Center","Bar, Jair","以色列","Ramat Gan","Ramat Gan"],["Rambam Health Care Campus","Shentzer Kutiel, Talia","以色列","Haifa","Haifa"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS – Università Cattolica del Sacro Cuore","Daniele, Gennaro","意大利","Roma","Roma"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Occhipinti, Mario","意大利","Milano","Milano"],["IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST)","Delmonte, Angelo","意大利","Meldola","Meldola"],["Istituto Clinico Humanitas- IRCCS","Santoro, Armando","意大利","Rozzano","Rozzano"],["Uniwersyteckie Centrum Kliniczne","Dziadziuszko, Rafal","波兰","Gdansk","Gdansk"],["Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie","Kowalski, Dariusz","波兰","Warszawa","Warszawa"],["Hospital Universitari Vall d'Hebron","ROCHA, PEDRO","西班牙","Barcelona","Barcelona"],["Hospital Universitario Insular de Gran Canaria","RODRIGUEZ ABREU, DELVYS","西班牙","Las Palmas De Gran Canaria","Las Palmas De Gran Canaria"],["Hospital Universitario Gregorio Maranon","Alvarez Alvarez, Rosa","西班牙","Madrid","Madrid"],["Hospital San Pedro","de Miguel Luken, Maria Jose","西班牙","Logrono","Logrono"],["Hacettepe Universitesi Tip Fakultesi Hastanesi","Erman, Mustafa","土耳其","Ankara","Ankara"],["Abdurrahman Yurtaslan Onkoloji Hastanesi","ATES, Ozturk","土耳其","Ankara","Ankara"],["Adana City Hospital","Cil, Timucin","土耳其","Adana","Adana"],["Koc üniversitesi Hastanesi","Gunduz, Seyda","土耳其","Istanbul","Istanbul"],["Samsung Medical Center","Sun, Jong-Mu","韩国","Seoul","Seoul"],["Seoul National University Hospital","Kim, Tae Min","韩国","Seoul","Seoul"],["Severance Hospital Yonsei University Health System","Cho, Byoung Chul","韩国","Seoul","Seoul"],["Asan Medical Center","Lee, Dae Ho","韩国","Seoul","Seoul"],["Sanatorio Parque","Martinengo, Gaston","阿根廷","Rosario","Rosario"],["Hospital Austral","Minatta, Nicolas","阿根廷","Pilar","Pilar"],["CEMIC","Greco, Martin","阿根廷","Caba.","Caba."],["Faculty of Medicine Siriraj Hospital","Danchaivijitr, Pongwut","泰国","Bangkoknoi","Bangkoknoi"],["Songklanagarind hospital","Sunpaweravong, Patrapim","泰国","Hat Yai","Hat Yai"],["Bangkok Metropolitan Administration Medical College and Vajira Hospital","Runglodvatana, Yotsawaj","泰国","Dusit","Dusit"],["SCRI Oncology Partners","Johnson, Melissa","美国","Tennessee","Nashville"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海市东方医院药物/器械临床试验伦理委员会","同意","2025-10-28"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 20 ； 国际: 170 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；