上海NAIII期临床试验-比较Tarlatamab（SC vs. IV）治疗含铂一线化疗后广泛期小细胞肺癌的3 期试验（DeLLphi-315）

登记号	CTR20262832	试验状态	进行中
申请人联系人	李越	首次公示信息日期	2026-07-22
申请人名称	Amgen Inc./ 百济神州（北京）生物科技有限公司

登记号	CTR20262832
相关登记号	暂无
药物名称	NA
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	小细胞肺癌
试验专业题目	一项在接受含铂一线化疗后的复发性广泛期小细胞肺癌试验参与者中比较Tarlatamab皮下给药与静脉给药的开放性、多中心、随机、3期研究
试验通俗题目	比较Tarlatamab（SC vs. IV）治疗含铂一线化疗后广泛期小细胞肺癌的3 期试验（DeLLphi-315）
试验方案编号	20250046	方案最新版本号	修订案0.1
版本日期:	2026-03-25	方案是否为联合用药	否

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@beonemed.com	联系人邮政地址	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

本研究的主要目的是证明Tarlatamab皮下给药（SC）与静脉给药（IV）的药代动力学（PK）参数非劣效性，次要目的是表征SC Tarlatamab和IV Tarlatamab的有效性、安全性和耐受性以及生活质量，并评估Tarlatamab的免疫原性。

试验分类	药代动力学/药效动力学试验	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	[["签署知情同意书时年龄≥ 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小细胞肺癌，在仅1种含铂方案治疗后表现出影像学进展或复发。"],["在21天筛选期间研究者根据RECIST 1.1标准定义的可测量病灶。"],["有中枢神经系统转移病史者，需满足方案规定条件则允许入组。"],["可提供诊断时留存的存档肿瘤组织。"],["美国东部肿瘤协作组（ECOG）体能状态（PS）评分为0或1。"],["器官功能良好。"],["有生育能力者必须同意方案规定的避孕措施。"],["其他方案定义的入选标准。"]]
排除标准	[["既往诊断为伴表皮生长因子受体（EGFR）激活突变的非小细胞肺癌（NSCLC），且已转化为SCLC，或组织学为SCLC与NSCLC混合型。"],["研究治疗首次给药前6个月内发生心肌梗死和/或症状性充血性心脏衰竭（纽约心脏病协会标准> II级）。"],["在研究治疗首次给药前6个月内有动脉血栓形成史。"],["目前存在或既往有需使用类固醇或其他免疫抑制治疗的非感染性肺炎/间质性肺疾病（ILD）证据或病史。"],["已知试验参与者对给药期间给予的任何产品或成分过敏或存在禁忌症。"],["入组前2年内有SCLC以外的其他恶性肿瘤病史。"],["未得到控制的胸腔积液、心包积液或腹水。"],["有实体器官移植史。"],["存在病毒性肝炎感染或相关病史。"],["研究治疗首次给药前28天内接受过重大手术。"],["试验参与者在研究治疗首次给药前7天内有提示急性和/或未受控制的活动性全身感染症状和/或临床体征和/或影像学表现。"],["入组前30天内接受过既往全身性抗肿瘤治疗。"],["任何免疫疗法导致的重度或危及生命的事件既往史。"],["在研究治疗首次给药前14天内接受过全身性皮质类固醇治疗或任何其他形式的免疫抑制治疗。"],["其他方案定义的排除标准。"]]

试验药	[["中文通用名:NA 英文通用名:Tarlatamab 商品名称:安泰适","剂型:NA 规格:NA 用法用量:NA 用药时程:NA"]] 序号 名称 用法
对照药	[["中文通用名:NA 英文通用名:Tarlatamab 商品名称:安泰适","剂型:冻干制剂 规格:1mg,10mg/瓶 用法用量:静脉给药Tarlatamab将以10mg目标剂量Q2W给药，在第1周期进行阶梯剂量给药（1mg）。 用药时程:直至出现疾病进展"]] 序号 名称 用法

主要终点指标及评价时间

[["Tarlatamab药代动力学（PK）参数：曲线下面积（AUCC2D1-D15）、给药前浓度（Ctrough）","第2周期第1天至第15天","有效性指标+安全性指标"]] 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

[["客观缓解（OR）","每次肿瘤评估，不超过4年","有效性指标"],["无进展生存期（PFS）","从随机化至首次记录疾病进展或全因死亡（以先发生者为准），不超过4年","有效性指标"],["缓解持续时间（DOR）","从首次记录OR至首次记录疾病进展或全因死亡，不超过4年","有效性指标"],["疾病控制（DC）","每次肿瘤评估，不超过4年","有效性指标"],["总生存期（OS）","从随机化至全因死亡，不超过4年","有效性指标"],["治疗中出现的不良事件（TEAE）和治疗相关不良事件（TRAE）的发生率，包括≥ 3级、严重和致死性不良事件以及关注事件","随机化开始，不超过4年","安全性指标"],["患者报告结局版不良事件通用术语标准","从随机化至安全性随访，不超过4年","安全性指标"],["癌症治疗功能评估通用量表（FACT-G的GP5)","从随机化至安全性随访，不超过4年","有效性指标+安全性指标"],["欧洲生活质量五水平五维健康量表（EQ-5D-5L）","从随机化至研究治疗末次给n药后12个月或末例试验参与者随机化后36个月（以先发生者为准），不超过4年","有效性指标+安全性指标"],["治疗给药满意度问卷（TASQ）","从随机化至安全性随访，不超过4年","有效性指标+安全性指标"],["抗Tarlatamab抗体形成的发生率","从随机化至安全性随访，不超过4年","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	任胜祥	学位	医学博士	职称	主任医师
	电话	13816756732	Email	harry_ren@126.com	邮政地址	上海市-上海市-政民路507号
	邮编	200433	单位名称	上海市肺科医院

[["上海市肺科医院","任胜祥","中国","上海市","上海市"],["四川大学华西医院","李璐","中国","四川省","成都市"],["哈尔滨医科大学附属肿瘤医院","赵艳滨","中国","黑龙江省","哈尔滨市"],["天津市肿瘤医院","黄鼎智","中国","天津市","天津市"],["吉林省肿瘤医院","刘海峰","中国","吉林省","长春市"],["山东第一医科大学附属肿瘤医院","朱慧","中国","山东省","济南市"],["北京肿瘤医院","余荣","中国","北京市","北京市"],["河南省肿瘤医院","王启鸣","中国","河南省","郑州市"],["江西省肿瘤医院","刘智华","中国","江西省","南昌市"],["辽宁省肿瘤医院","梁媛","中国","辽宁省","沈阳市"],["云南省肿瘤医院","杨润祥","中国","云南省","昆明市"],["四川省肿瘤医院","周进","中国","四川省","成都市"],["河北医科大学第四医院","王军","中国","河北省","石家庄市"],["南昌大学第一附属医院","孙龙华","中国","江西省","南昌市"],["福建省肿瘤医院","张晶","中国","福建省","福州市"],["首都医科大学附属北京朝阳医院","葛洋","中国","北京市","北京市"],["山西白求恩医院","张俊萍","中国","山西省","太原市"],["宁波大学附属第一医院","黄微娜","中国","浙江省","宁波市"],["广西医科大学附属肿瘤医院","曾爱屏","中国","广西壮族自治区","南宁市"],["重庆大学附属肿瘤医院","李咏生","中国","重庆市","重庆市"],["Calvary Mater Newcastle Hospital","Ina Nordman","澳大利亚","NSW","Waratah"],["Greenslopes Private Hospital","Kenneth O Byrne","澳大利亚","QLD","Greenslopes"],["Lyell McEwin Hospital","Dainik Patel","澳大利亚","SA","Elizabeth Vale"],["Sunshine Hospital","Azim Jalali","澳大利亚","VIC","St Albans"],["Universitair Ziekenhuis Leuven - Campus Gasthuisberg","Els Wauters","比利时","Leuven","Leuven"],["Algemeen Ziekenhuis Sint-Jan Brugge-Oostende","Rebecca De Pauw","比利时","Brugge","Brugge"],["Algemeen Ziekenhuis Sint Maarten-Emmaus vzw","Annelies Leyssens","比利时","Mechelen","Mechelen"],["Universite Catholique de Louvain Cliniques Universitaires Saint Luc","Frank Aboubakar Nana","比利时","Bruxelles","Bruxelles"],["Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne","Sebahat Ocak","比利时","Yvoir","Yvoir"],["AZ Delta Campus Rumbeke","Ingel Demedts","比利时","Roeselare","Roeselare"],["Algemeen Ziekenhuis Groeninge - Campus Kennedylaan","Sofie Derijcke","比利时","Kortrijk","Kortrijk"],["Jessa Ziekenhuis - Campus Virga Jesse","Kristof Cuppens","比利时","Hasselt","Hasselt"],["Cenantron Centro Avan？ado de Tratamento Oncologico Ltda","Lorraine Eloy Silva","巴西","Minas Gerais","Belo Horizonte"],["Centro de Pesquisa do Hospital Albert Einstein","Fernando Moura Silva","巴西","Sao Paulo","Sao Paulo"],["Fund Faculdade Regional Med Sao Jose Rio Preto","Maira Silva Abreu","巴西","Sao Paulo","Sao Jose do Rio Preto"],["Fundacao pio xII Barretos","Gustavo Dix Junqueira Pinto","巴西","Sao Paulo","Barretos"],["Cross Cancer Institute","Quincy Chu","加拿大","AB","Edmonton"],["Brampton Civic Hospital","Parneet Cheema","加拿大","ON","Brampton"],["Princess Margaret Cancer Centre","Adrian Sacher","加拿大","ON","Toronto"],["Centre Hospitalier Universitaire Nord","Laurent Greillier","法国","Marseille","Marseille"],["Hopital de la Croix Rousse","Oriane Pelton","法国","Lyon","Lyon"],["Centre Hospitalier Universitaire de Toulouse - Hopital Larrey","Julien Mazieres","法国","Toulouse Cedex 9","Toulouse Cedex 9"],["Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou","Charles Ricordel","法国","Rennes Cedex 9","Rennes Cedex 9"],["Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec","Elvire Pons-Tostivint","法国","Nantes","Nantes"],["Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz","Virginie Westeel","法国","Besan？on","Besan？on"],["Universitaetsklinikum Schleswig-Holstein - Luebeck","Sabine Bohnet","德国","Luebeck","Luebeck"],["Universitaetsklinikum Heidelberg","Farastuk Bozorgmehr","德国","Heidelberg","Heidelberg"],["Klinikum Chemnitz GmbH","Stefan Hammerschmidt","德国","Chemnitz","Chemnitz"],["Universitaetsklinikum Wuerzburg","Horst-Dieter Hummel","德国","Wuerzburg","Wuerzburg"],["LungenClinic Grosshansdorf GmbH","Martin Reck","德国","Grosshansdorf","Grosshansdorf"],["Universitaetsklinikum Schleswig-Holstein - Kiel","Matthias Ritgen","德国","Kiel","Kiel"],["Helios Kliniken Emil-von-Behring","Sebastian Thiel","德国","Berlin","Berlin"],["Asklepios Fachkliniken Muenchen Gauting","Niels Reinmuth","德国","Gauting","Gauting"],["Klinikum Kempten - Oberallgaeu gGmbH","Christian Schumann","德国","Kempten","Kempten"],["Universitaetsklinikum Koeln","Juergen Wolf","德国","Koeln","Koeln"],["Henry Dunant Hospital Center","Ioannis Mountzios","希腊","Athens","Athens"],["University Hospital of Larissa","Athanasios Kotsakis","希腊","Larissa","Larissa"],["University Hospital of Heraklion","Sofia Agelaki","希腊","Heraklion","Heraklion"],["Alexandra Hospital","Maria Gavriatopoulou","希腊","Athens","Athens"],["Thoracic General Hospital Of Athens I Sotiria","Konstantinos Syrigos","希腊","Athens","Athens"],["Saint Luke Hospital","Eleni Fountzila","希腊","Thessaloniki","Thessaloniki"],["European Interbalkan Medical Center","Ippokratis Korantzis","希腊","Thessaloniki","Thessaloniki"],["Matrai Gyogyintezet","Istvan Albert","匈牙利","Gyongyos","Gyongyos"],["Orszagos Koranyi Pulmonologiai Intezet","Andrea Fulop","匈牙利","Budapest","Budapest"],["Reformatus Pulmonologiai Centrum","Gabriella Galffy","匈牙利","Torokbalint","Torokbalint"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Mario Occhipinti","意大利","Milano","Milano"],["Centro Ricerche Cliniche Di Verona Societa responsabilita limitata","Jessica Menis","意大利","Verona","Verona"],["Azienda Ospedaliera San Giovanni Addolorata","Antonio Lugini","意大利","Roma","Roma"],["IRCCS Istituto Tumori Giovanni Paolo II","Vito Longo","意大利","Bari","Bari"],["iNOC Istituto Nazionale Oncologico Candiolo Istituto Ricovero e Cura Carattere Scientifico","Chiara Lazzari","意大利","Candiolo","Candiolo"],["National Hospital Organization Nagoya Medical Center","Masahide Oki","日本","Aichi","Nagoya-shi"],["Asahi General Hospital","Ryoichi Honda","日本","Chiba","Asahi-shi"],["Kurume University Hospital","Koichi Azuma","日本","Fukuoka","Kurume-shi"],["National Hospital Organization Hokkaido Cancer Center","Hiroshi Yokouchi","日本","Hokkaido","Sapporo-shi"],["Kobe Minimally invasive Cancer Center","Akito Hata","日本","Hyogo","Kobe-shi"],["Hyogo Cancer Center","Miyako Satouchi","日本","Hyogo","Akashi-shi"],["Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center","Shuhei Teranishi","日本","Kanagawa","Yokohama-shi"],["Niigata University Medical and Dental Hospital","Satoshi Watanabe","日本","Niigata","Niigata-shi"],["Osaka International Cancer Institute","Kazumi Nishino","日本","Osaka","Osaka-shi"],["Osaka Medical and Pharmaceutical University Hospital","Yosuke Tamura","日本","Osaka","Takatsuki-shi"],["Kansai Medical University Hospital","Takayasu Kurata","日本","Osaka","Hirakata-shi"],["Shizuoka Cancer Center","Kazushige Wakuda","日本","Shizuoka","Sunto-gun"],["Dokkyo Medical University Hospital","Seiji Niho","日本","Tochigi","Shimotsuga-gun"],["The Cancer Institute Hospital of Japanese Foundation for Cancer Research","Ken Uchibori","日本","Tokyo","Koto-ku"],["Tokyo Metropolitan Komagome Hospital","Kageaki Watanabe","日本","Tokyo","Bunkyo-ku"],["Erasmus Medisch Centrum","Daphne Dumoulin","荷兰","Rotterdam","Rotterdam"],["Radboud Universitair Medisch Centrum","Wouter van Geffen","荷兰","Nijmegen","Nijmegen"],["Isala Zwolle","Peter Plomp","荷兰","Zwolle","Zwolle"],["Universitair Medisch Centrum Utrecht","Anne Van Lindert","荷兰","Utrecht","Utrecht"],["Amsterdam umc","Sayed Hashemi","荷兰","Amsterdam","Amsterdam"],["Uniwersyteckie Centrum Kliniczne","Piotr Wysocki","波兰","Gdansk","Gdansk"],["Instytut Gruzlicy i Chorob Pluc","Mateusz Polaczek","波兰","Warszawa","Warszawa"],["Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy","Dariusz Kowalski","波兰","Warszawa","Warszawa"],["Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio","Antonio Araujo","葡萄牙","Porto","Porto"],["Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano","Fernanda Estevinho","葡萄牙","Matosinhos","Matosinhos"],["Hospital Cuf Tejo","Telma Sequeira","葡萄牙","Lisboa","Lisboa"],["Unidade Local de Saude de Braga, EPE","Daniela Marques","葡萄牙","Braga","Braga"],["Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca","Tudor-Eliade Ciuleanu","罗马尼亚","Cluj Napoca","Cluj Napoca"],["Centrul de Diagnostic si Tratament Provita SA","Mircea Dediu","罗马尼亚","Bucuresti","Bucuresti"],["Institutul Regional de Oncologie Iasi","Dana Clement","罗马尼亚","Iasi","Iasi"],["Asociatia Oncohelp","Mihaela-Maria Pasca-Fenesan","罗马尼亚","Timisoara","Timisoara"],["Seoul National University Bundang Hospital","Yu Jung Kim","韩国","Seongnam-si, Gyeonggi-do","Seongnam-si, Gyeonggi-do"],["Asan Medical Center","Dae Ho Lee","韩国","Seoul","Seoul"],["Chungbuk National University Hospital","Ki Hyeong Lee","韩国","Cheongju Chungbuk","Cheongju Chungbuk"],["Severance Hospital Yonsei University Health System","Sun Min Lim","韩国","Seoul","Seoul"],["Hospital Regional Universitario de Malaga","Maria Vanesa Gutierrez Calderon","西班牙","Andalucía","Malaga"],["Hospital Universitario Insular de Gran Canaria","Delvys Rodriguez Abreu","西班牙","Canarias","Las Palmas de Gran Canaria"],["Hospital Universitari Vall d Hebron","Pedro Filipe Simoes Da Rocha","西班牙","Cataluna","Barcelona"],["Hospital Universitari i Politecnic La Fe","Oscar Jose Juan Vidal","西班牙","Comunidad Valenciana","Valencia"],["Complexo Hospitalario Universitario A Coruna Hospital Teresa Herrera","Maria Rosario Garcia Campelo","西班牙","Galicia","A Coruna"],["Hospital Universitario 12 de Octubre","Luis Paz-Ares Rodriguez","西班牙","Madrid","Madrid"],["Hospital Universitario Puerta de Hierro Majadahonda","Mariano Provencio Pulla","西班牙","Madrid","Majadahonda"],["Hospital Universitario Ramon y Cajal","Maria Eugenia Olmedo Garcia","西班牙","Madrid","Madrid"],["Hospital de la Santa Creu i Sant Pau","Margarita Majem Tarruella","西班牙","Barcelona","Barcelona"],["Universitaetsspital Zuerich","Laura Boos","瑞士","Zuerich","Zuerich"],["Kantonsspital Sankt Gallen","Martin Frueh","瑞士","Sankt Gallen","Sankt Gallen"],["Universitaetsspital Basel","Christian Frenzel","瑞士","Basel","Basel"],["Centre Hospitalier Universitaire Vaudois","Nuria Mederos Alfonso","瑞士","Lausanne","Lausanne"],["National Taiwan University Hospital","Jin-Yuan Shih","中国台湾","Taipei","Taipei"],["Taipei Veterans General Hospital","Chi-Lu Chiang","中国台湾","Taipei","Taipei"],["Istinye Universitesi Liv Hospital Topkapi","Irfan Cicin","土耳其","Istanbul","Istanbul"],["Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi","Mehmet Besiroglu","土耳其","Istanbul","Istanbul"],["Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi","Ozgur Ozyilkan","土耳其","Adana","Adana"],["Memorial Ankara Hastanesi","Umut Demirci","土耳其","Ankara","Ankara"],["Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi","Ismail Erturk","土耳其","Ankara","Ankara"],["Sakarya Egitim ve Arastirma Hastanesi","Ilhan Hacibekiroglu","土耳其","Sakarya","Sakarya"],["Kocaeli Universitesi Tip Fakultesi Hastanesi","Devrim Cabuk","土耳其","Kocaeli","Kocaeli"],["Christie Hospital","Martin Igor Gomez-Randulfe Rodriguez","英国","Manchester","Manchester"],["Sarah Cannon Research Institute UK","Anja Williams","英国","London","London"],["The London Clinic","Dionysis Papadatos Pastos","英国","London","London"],["Cancer Specialists of North Florida","Laura Lourdes","美国","FL","Jacksonville"],["University of Florida Health Cancer Center at Orlando Health","Yuanbin Chen","美国","FL","Orlando"],["AdventHealth Hematology and Oncology","Tarek Mekhail","美国","FL","Orlando"],["Iowa City Veterans Affairs Health Care System","William Zeitler","美国","IA","Iowa City"],["University of Chicago","Noura Choudhury","美国","IL","Chicago"],["University of Kansas Medical Center","Lara Kujtan","美国","KS","Kansas City"],["Cancer and Hematology Centers of Western Michigan","Eric Santos","美国","MI","Grand Rapids"],["Health Partners Cancer Center at Regions Hospital","Timothy Larson","美国","MN","St. Paul"],["FirstHealth Cancer Center","Charles Kuzma","美国","NC","Pinehurst"],["Oncology Hematology West PC","Joel Michalski","美国","NE","Omaha"],["Nebraska Hematology Oncology PC","Kailash Mosalpuria","美国","NE","Lincoln"],["Rutgers Cancer Institute of New Jersey","Missak Haigentz","美国","NJ","New Brunswick"],["Perlmutter Cancer Center at New York University Langone Hospital - 34th Street","Salman Punekar","美国","NY","New York"],["Cleveland Clinic Foundation","Lukas Delasos","美国","OH","Cleveland"],["University of Pittsburgh Medical Center Hillman Cancer Center","Liza Villaruz","美国","PA","Pittsburgh"],["Avera Cancer Institute","Benjamin Solomon","美国","SD","Sioux Falls"],["University of Texas Health Science Center at Tyler","Erminia Massarelli","美国","TX","Tyler"],["Virginia Oncology Associates","John Paschold","美国","VA","Norfolk"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海市肺科医院医学伦理委员会","同意","2026-05-21"]]

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: 75 ； 国际: 400 ；
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；