上海TarlatamabIII期临床试验-比较Tarlatamab、度伐利尤单抗、卡铂和依托泊苷与度伐利尤单抗、卡铂和依托泊苷一线治疗ES-SCLC的研究（DeLLphi-312）

登记号	CTR20252997	试验状态	进行中
申请人联系人	李越	首次公示信息日期	2025-07-28
申请人名称	Amgen Inc./ 百济神州（北京）生物科技有限公司

登记号	CTR20252997
相关登记号	暂无
药物名称	Tarlatamab
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	广泛期小细胞肺癌
试验专业题目	一项在未经治疗的广泛期小细胞肺癌患者中比较Tarlatamab联合度伐利尤单抗、卡铂和依托泊苷与度伐利尤单抗、卡铂和依托泊苷一线治疗的3期、开放性、多中心、随机研究（DeLLphi-312）
试验通俗题目	比较Tarlatamab、度伐利尤单抗、卡铂和依托泊苷与度伐利尤单抗、卡铂和依托泊苷一线治疗ES-SCLC的研究（DeLLphi-312）
试验方案编号	20240178	方案最新版本号	20240178（增补版本1）
版本日期:	2025-03-06	方案是否为联合用药	是

申请人名称	[["Amgen Inc."],["百济神州（北京）生物科技有限公司"]]
联系人姓名	李越	联系人座机	4008203-159	联系人手机号
联系人Email	ClinicalTrials@beigene.com	联系人邮政地址	北京市-北京市-北京市昌平区中关村生命科学园，科学院路30号	联系人邮编	102206

比较Tarlatamab联合度伐利尤单抗、卡铂和依托泊苷与度伐利尤单抗、卡铂和依托泊苷联合治疗在延长总生存期（OS）、基于研究者根据实体瘤疗效评价标准（RECIST）1.1评估的无进展生存期（PFS）、客观缓解（OR）、疾病控制（DC）和缓解持续时间（DOR）等方面的有效性、安全性和耐受性

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	[["受试者在开始任何研究特定活动/程序之前已提供知情同意。"],["年龄≥ 18岁（若该国家/地区的法定成年年龄大于18岁，则需≥该法定成年年龄）"],["经组织学或细胞学证实的广泛期小细胞肺癌（美国癌症联合委员会，2017年，IV期SCLC [任何T、任何N、M1 a/b/c]），或者 T3-T4 由于肺部多发结节或者肿瘤/结节体积过大而不能被包含在一个可耐受的放疗计划中。"],["RECIST 1.1定义的可测量疾病。"],["据研究医生的临床评估，适合接受卡铂、依托泊苷和度伐利尤单抗方案作为一线治疗。"],["预期寿命≥ 12周。"]]
排除标准	[["症状性中枢神经系统（CNS）转移或软脑膜疾病。"],["既往确诊为转化的非小细胞肺癌（NSCLC）、转化为SCLC（小细胞肺癌）的表皮生长因子受体（EGFR）激活突变阳性NSCLC或混合型SCLC NSCLC组织学类型。"],["过去2年内有其他恶性肿瘤病史。"],["活动性或既往记录的自身免疫性或炎症性疾病."],["研究治疗首次给药前6个月内发生心肌梗死和/或症状性充血性心力衰竭（纽约心脏病协会标准> II级）。"],["有证据表明存在间质性肺疾病（ILD）或活动性非感染性肺炎。"],["有实体器官移植史。"],["存在活动性HIV或活动性肝炎感染。"]]

试验药

[["中文通用名:AMG757 英文通用名:Tarlatamab 商品名称:NA","剂型:注射用无菌粉末 规格:1mg/瓶&10mg/瓶 用法用量:在第1周期第1天给予1mg的分步剂量。剂量水平Q3W（每3周为一个周期）：第1周期第8天20mg，第2周期第1天、第3周期第1天和第4周期第1天20mg。剂量水平Q2W（每4周为一个周期）：第5周期第1天10mg，第5周期第15天10mg，此后10mgQ2W。 用药时程:60（±10）分钟"]] 序号 名称 用法

对照药

[["中文通用名:度伐利尤单抗注射液 英文通用名:DurvalumabInjection 商品名称:英飞凡IMFINZI","剂型:注射剂 规格:50mg/mL 用法用量:从第1周期至第4周期，在每个21天周期的第1天，在第4周期后，在每个28天周期的第1天：给药剂量为1500mg（体重≥30kg的受试者）或20mg/kg（体重用药时程:60（±10）分钟"],["中文通用名:注射用卡铂 英文通用名:CarboplatinInjection 商品名称:NA","剂型:注射剂 规格:10mg/ml 用法用量:在第1周期至第4周期，卡铂将在每个21天周期的第1天以曲线下面积（AUC）剂量5mg/mL/min（Calvert公式计算，AUC5的最大剂量上限为750mg）输注。 用药时程:30至60分钟"],["中文通用名:依托泊苷注射液 英文通用名:EtoposideInjectoin 商品名称:NA","剂型:注射剂 规格:20mg/mL 用法用量:在每个21天周期的第1天至第3天IV输注依托泊苷100mg/m2 用药时程:60分钟"]] 序号 名称 用法

主要终点指标及评价时间

[["总生存期（OS）","最长约3.5 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

[["无进展生存期","最长约4年","有效性指标"],["客观缓解（OR）","最长约4年","有效性指标"],["疾病控制（DC）","最长约4年","有效性指标"],["缓解持续时间（DOR)","最长约4年","有效性指标"],["无进展生存期(PFS) 比例","6个月， 1年 和2年","有效性指标"],["总生存期（OS) 比例","6个月， 1年 和2年","有效性指标"],["至疾病进展时间（TTP)","最长约4年","有效性指标"],["治疗期间的不良事件（TEAE）数量","最长约4年","安全性指标"],["治疗相关不良事件（TRAE）数量","最长约4年","安全性指标"],["关注事件（EOI）数量","最长约4年","安全性指标"],["Tarlatamab的血清浓度","最长约1年","有效性指标+安全性指标"],["抗Tarlatamab抗体形成的发生数量","最长13个月","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	陆舜	学位	医学博士	职称	主任医师
	电话	021-22200000-3123	Email	shunlu_shchest@sina.com	邮政地址	上海市-上海市-上海市淮海西路241号
	邮编	200030	单位名称	上海市胸科医院

[["上海市胸科医院","陆舜","中国","上海市","上海市"],["上海市胸科医院","艾星浩","中国","上海市","上海市"],["四川大学华西医院","李潞","中国","四川省","成都市"],["福建省肿瘤医院","张晶","中国","福建省","福州市"],["天津市肿瘤医院","庞青松","中国","天津市","天津市"],["北京大学肿瘤医院","方健","中国","北京市","北京市"],["北京大学肿瘤医院","赵军","中国","北京市","北京市"],["山西省肿瘤医院","宋霞","中国","山西省","太原市"],["江西省肿瘤医院","郭善娴","中国","江西省","南昌市"],["中山大学肿瘤防治中心","周宁宁","中国","广东省","广州市"],["山东省肿瘤","王海永","中国","山东省","济南市"],["南昌大学第一附属医院","孙龙华","中国","江西省","南昌市"],["上海肺科医院","何雅億","中国","上海市","上海市"],["天津市人民医院","王华庆","中国","天津市","天津市"],["佳木斯市肿瘤医院","孙红梅","中国","黑龙江省","佳木斯市"],["吉林大学第一医院","崔久嵬","中国","吉林省","长春市"],["宁波大学附属第一医院","黄微娜","中国","浙江省","宁波市"],["临沂市肿瘤医院","王珍","中国","山东省","临沂市"],["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"],["河南省肿瘤医院","王启鸣","中国","河南省","郑州市"],["福建医科大学附属第二医院","杨栋勇","中国","福建省","泉州市"],["Sanatorio Parque SA","Gaston Martinengo","Argentina","Rosario","Rosario"],["Hospital Universitario Austral","Manglio Miguel Rizzo","Argentina","Pilar","Pilar"],["Cemic","Vanina Wainsztein","Argentina","Buenos Aires","Buenos Aires"],["Monash Medical Centre","Surein Arulananda","Australia","Melbourne","Melbourne"],["Fiona Stanley Hospital","Christopher Lomma","Australia","Perth","Perth"],["Chris OBrien Lifehouse","Malinda Itchins","Australia","Sydney","Sydney"],["Medizinische Universitaet Graz","Philipp Jost","Austria","Graz","Graz"],["Universitaetsklinikum Krems","Sabin Handzhiev","Austria","Krems","Krems"],["Universitair Ziekenhuis Leuven - Campus Gasthuisberg","Els Wauters","Belgium","Leuven","Leuven"],["AZ Delta Campus Rumbeke","Ingel Demedts","Belgium","Roeselare","Roeselare"],["Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne","Sebahat Ocak","Belgium","Namur","Namur"],["Centre Hospitalier Universitaire de Liege - Sart Tilman","Astrid Paulus","Belgium","Liege","Liege"],["Jessa Ziekenhuis - Campus Virga Jesse","Kristof Cuppens","Belgium","Hasselt","Hasselt"],["Fund Fac Reg Med Sao Jose Rio Preto","Joao Antonio Soler","Brazil","Sao Jose do Rio Preto","Sao Jose do Rio Preto"],["Liga Norte-Riograndense Contra O Cancer","Wendel Ferreira Costa","Brazil","Natal","Natal"],["Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul","Ana Caroline Gelatti","Brazil","Porto Alegre","Porto Alegre"],["Centro de Pesquisa do Hospital Albert Einstein","Gustavo Schvartsman","Brazil","Sao Paulo","Sao Paulo"],["Cenantron Centro Avan？ado de Tratamento Oncologico Ltda","Andre Marcio Murad","Brazil","Belo Horizonte","Belo Horizonte"],["Fundacao Antonio Prudente","Thiago Bueno de Oliveira","Brazil","Sao Paulo","Sao Paulo"],["Rigshospitalet","Seppo Langer","Denmark","Copenhagen","Copenhagen"],["Regionshospitalet Godstrup","Trine Heide Oellegaard","Denmark","Herning","Herning"],["Centre Hospitalier Universitaire Nord","Laurent Greillier","France","Marseille","Marseille"],["Hopital d instruction des armees sainte anne","Olivier Bylicki","France","Toulon","Toulon"],["Centre Hospitalier Universitaire de Toulouse - Hopital Larrey","Julien Mazieres","France","Toulouse","Toulouse"],["Institut Curie","Nicolas Girard","France","Paris","Paris"],["Centre Hospitalier Intercommunal de Creteil","Jean-Bernard Auliac","France","Creteil","Creteil"],["Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec","Elvire Pons-Tostivint","France","Nantes","Nantes"],["Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle","Florian Guisier","France","Rouen","Rouen"],["Centre Leon Berard","Maurice Perol","France","Lyon","Lyon"],["Universitaetsklinikum Essen","Michael Pogorzelski","Germany","Essen","Essen"],["Universitaetsklinikum Dresden","Martin Wermke","Germany","Dresden","Dresden"],["Asklepios Fachkliniken Muenchen Gauting","Niels Reinmuth","Germany","Munich","Munich"],["Universitaetsklinikum Wuerzburg","Horst-Dieter Hummel","Germany","Wuerzburg","Wuerzburg"],["Krankenhaus Koeln-Merheim – Kliniken der Stadt Koeln gGmbH","Eva-Lotte Buchmeier","Germany","Cologne","Cologne"],["Universitaetsklinikum Schleswig-Holstein","Matthias Ritgen","Germany","Kiel","Kiel"],["LungenClinic Grosshansdorf GmbH","Martin Reck","Germany","Grosshansdorf","Grosshansdorf"],["Universitaetsklinikum Schleswig-Holstein - Luebeck","Sabine Bohnet","Germany","Luebeck","Luebeck"],["Krankenhaus Nordwest","Akin Atmaca","Germany","Frankfurt","Frankfurt"],["Klinikum Chemnitz GmbH","Stefan Hammerschmidt","Germany","Chemnitz","Chemnitz"],["European Interbalkan Medical Center","Ippokratis Korantzis","Greece","Thessaloniki","Thessaloniki"],["Alexandra Hospital","Michalis Liontos","Greece","Athens","Athens"],["Iatriko Diavalkaniko Thessalonikis","Sofia Baka","Greece","Thessaloniki","Thessaloniki"],["Henry Dunant Hospital Center","Ioannis Mountzios","Greece","Athens","Athens"],["Queen Mary Hospital, The University of Hong Kong","Rina Hui","中国香港","Hong Kong","Hong Kong"],["Prince of Wales Hospital, Chinese University of Hong Kong","Herbert Loong","中国香港","Hong Kong","Hong Kong"],["Orszagos Koranyi Pulmonologiai Intezet","Judit Moldvay","Hungary","Budapest","Budapest"],["Matrai Gyogyintezet","Istvan Albert","Hungary","Matrahaza","Matrahaza"],["Reformatus Pulmonologiai Centrum","Gabriella Galffy","Hungary","Debrecen","Debrecen"],["Rabin Medical Center","Ekaterina Hanovich","Israel","Petah Tikva","Petah Tikva"],["Meir Medical Center","Natalie Maimon-Rabinovich","Israel","Kfar Saba","Kfar Saba"],["Humanitas Gavazzeni","Chiara Matilde Catania","Italy","Bergamo","Bergamo"],["Istituto Romagnolo per lo Studio dei Tumori Dino Amadori","Angelo Delmonte","Italy","Meldola","Meldola"],["Azienda Ospedaliera San Giovanni Addolorata","Antonio Lugini","Italy","Rome","Rome"],["IRCCS Istituto Tumori Giovanni Paolo II","Vito Longo","Italy","Bari","Bari"],["Centro Ricerche Cliniche Di Verona Societa responsabilita limitata","Jessica Menis","Italy","Verona","Verona"],["IRCCS Istituto Oncologico Europeo","Filippo De Marinis","Italy","Milan","Milan"],["Wakayama Medical University Hospital","Hiroaki Akamatsu","Japan","Wakayama","Wakayama"],["Kyushu University Hospital","Isamu Okamoto","Japan","Fukuoka","Fukuoka"],["Kurume University Hospital","Koichi Azuma","Japan","Kurume","Kurume"],["Okayama University Hospital","Kadoaki Ohashi","Japan","Okayama","Okayama"],["Osaka International Cancer Institute","Kazumi Nishino","Japan","Osaka","Osaka"],["Kindai University Hospital","Takayuki Takahama","Japan","Osaka","Osaka"],["Shizuoka Cancer Center","Kazushige Wakuda","Japan","Shizuoka","Shizuoka"],["Kansai Medical University Hospital","Takayasu Kurata","Japan","Hirakata","Hirakata"],["Hyogo Cancer Center","Miyako Satouchi","Japan","Akashi","Akashi"],["Niigata Cancer Center Hospital","Hiroshi Tanaka","Japan","Niigata","Niigata"],["National Hospital Organization Hokkaido Cancer Center","Hidenori Mizugaki","Japan","Sapporo","Sapporo"],["Saitama Medical University International Medical Center","Ou Yamaguchi","Japan","Hidaka","Hidaka"],["National Hospital Organization Shikoku Cancer Center","Yuka Kato","Japan","Matsuyama","Matsuyama"],["Erasmus Medisch Centrum","Anne-Marie Dingemans","Netherlands","Rotterdam","Rotterdam"],["Universitair Medisch Centrum Groningen","Jeroen Hiltermann","Netherlands","Groningen","Groningen"],["Maastricht Universitair Medisch Centrum","Lizza Hendriks","Netherlands","Maastricht","Maastricht"],["Uniwersyteckie Centrum Kliniczne","Krzysztof Konopa","Poland","Gdansk","Gdansk"],["Instytut Gruzlicy i Chorob Pluc","Mateusz Polaczek","Poland","Warsaw","Warsaw"],["Centrum Pulmonologii i Torakochirurgii w Bystrej","Beata Kania-Zembaczynska","Poland","Bystra","Bystra"],["Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano","Fernanda Estevinho","Portugal","Matosinhos","Matosinhos"],["Hospital da Luz, SA","Joao Moreira Pinto","Portugal","Lisbon","Lisbon"],["Hospital Cuf Tejo","Telma Sequeira","Portugal","Lisbon","Lisbon"],["Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca","Tudor-Eliade Ciuleanu","Romania","Cluj-Napoca","Cluj-Napoca"],["Institutul Regional de Oncologie Iasi","Dana Clement","Romania","Iasi","Iasi"],["Severance Hospital Yonsei University Health System","Byoung Chul Cho","South Korea","Seoul","Seoul"],["National Cancer Center","Ji-Youn Han","South Korea","Goyang","Goyang"],["Chungbuk National University Hospital","Ki Hyeong Lee","South Korea","Cheongju","Cheongju"],["Hospital Universitario 12 de Octubre","Luis Paz-Ares Rodriguez","Spain","Madrid","Madrid"],["Hospital Universitario Ramon y Cajal","Maria Eugenia Olmedo Garcia","Spain","Madrid","Madrid"],["Hospital Universitari Vall d Hebron","Pedro Filipe Simoes Da Rocha","Spain","Barcelona","Barcelona"],["Hospital Universitari i Politecnic La Fe","Oscar Jose Juan Vidal","Spain","Valencia","Valencia"],["Hospital de la Santa Creu i Sant Pau","Margarita Majem Tarruella","Spain","Barcelona","Barcelona"],["Hospital Clinic i Provincial de Barcelona","Noemi Reguart Aransay","Spain","Barcelona","Barcelona"],["Hospital Universitario Puerta de Hierro Majadahonda","Mariano Provencio Pulla","Spain","Madrid","Madrid"],["Hospital Regional Universitario de Malaga","Maria Vanesa Gutierrez Calderon","Spain","Malaga","Malaga"],["Universitaetsspital Basel","Andreas Schmitt","Switzerland","Basel","Basel"],["Hopitaux universitaires de Geneve","Alfredo Addeo","Switzerland","Geneva","Geneva"],["Taipei Veterans General Hospital","Chi-Lu Chiang","中国台湾","Taipei","Taipei"],["National Cheng Kung University Hospital","Chien-Chung Lin","中国台湾","Tainan","Tainan"],["Ankara Bilkent Sehir Hastanesi","Mehmet Ali Sendur","Turkiye","Ankara","Ankara"],["Ege Universitesi Tip Fakultesi Hastanesi","Erdem Goker","Turkiye","Izmir","Izmir"],["Memorial Ankara Hastanesi","Umut Demirci","Turkiye","Ankara","Ankara"],["Bagcilar Medipol Mega Universite Hastanesi","Ahmet Bilici","Turkiye","Istanbul","Istanbul"],["Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi","Mahmut Gumus","Turkiye","Istanbul","Istanbul"],["Sakarya Egitim ve Arastirma Hastanesi","Ilhan Hacibekiroglu","Turkiye","Adapazar？","Adapazar？"],["West Virginia University Health Sciences Center","Mohammed Almubarak","United States","Morgantown","Morgantown"],["University Hospitals Cleveland Medical Center","Afshin Dowlati","United States","Cleveland","Cleveland"],["Oncology Hematology Care, Inc","Patrick Ward","United States","Cincinnati","Cincinnati"],["Yale New Haven Hospital","Anne Chiang","United States","New Haven","New Haven"],["University of Illinois Chicago","Frank Weinberg","United States","Chicago","Chicago"],["Dana Farber Cancer Institute","Jacob Sands","United States","Boston","Boston"],["Swedish Cancer Institute Medical Oncology","Kelly Paulson","United States","Seattle","Seattle"],["University of California Los Angeles","Jonathan Goldman","United States","Los Angeles","Los Angeles"],["Mayo Clinic","Konstantinos Leventakos","United States","Rochester","Rochester"],["Allina Health System dba Allina Health Cancer Institute","Charlene Fares","United States","Minneapolis","Minneapolis"],["Indiana University Melvin and Bren Simon Cancer Center","Misty Shields","United States","Indianapolis","Indianapolis"],["Kaiser Permanente Medical Center","Sandeep Mashru","United States","Oakland","Oakland"],["New York University Grossman School of Medicine and New York University Langone Hospitals","Salman Punekar","United States","New York","New York"],["Minnesota Oncology Hematology PA","Eric Lander","United States","Minneapolis","Minneapolis"],["Cancer Center of Kansas, Heritage Plaza Medical Building","Shaker Dakhil","United States","Wichita","Wichita"],["Saint Bernards Medical Center","Mazen Khalil","United States","Jonesboro","Jonesboro"],["Texas Oncology Northeast Texas","Sarah Yue Wang","United States","Tyler","Tyler"],["Virginia Oncology Associates","John Paschold","United States","Norfolk","Norfolk"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海市胸科医院伦理委员会","同意","2025-04-28"]]

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: 60 ； 国际: 330 ；
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；