上海BMS-986489III期临床试验-BMS-986489（BMS-986012 + 纳武利尤单抗固定剂量复方制剂）联合化疗对比阿替利珠单抗联合化疗作为广泛期小细胞肺癌受试者的一线治疗（TIGOS）

登记号	CTR20251471	试验状态	进行中
申请人联系人	冯倩	首次公示信息日期	2025-04-17
申请人名称	Bristol-Myers Squibb Company/ 百时美施贵宝（中国）投资有限公司/ Bristol Myers Squibb Co.

登记号	CTR20251471
相关登记号	CTR20251377
药物名称	BMS-986489
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BMS-986489（BMS-986012 + 纳武利尤单抗固定剂量复方制剂）联合卡铂 + 依托泊苷对比阿替利珠单抗联合卡铂 + 依托泊苷作为广泛期小细胞肺癌受试者一线治疗的随机、双盲、多中心3期试验（TIGOS）
试验通俗题目	BMS-986489（BMS-986012 + 纳武利尤单抗固定剂量复方制剂）联合化疗对比阿替利珠单抗联合化疗作为广泛期小细胞肺癌受试者的一线治疗（TIGOS）
试验方案编号	CA2450001	方案最新版本号	原始方案
版本日期:	2024-08-20	方案是否为联合用药	否

申请人名称	[["Bristol-Myers Squibb Company"],["百时美施贵宝（中国）投资有限公司"],["Bristol Myers Squibb Co."]]
联系人姓名	冯倩	联系人座机	021-23218384	联系人手机号	13918685974
联系人Email	Qian.Feng@bms.com	联系人邮政地址	上海市-上海市-静安区南京西路1717号12楼	联系人邮编	200040

比较随机分配至BMS-986489联合卡铂 + 依托泊苷治疗4个周期（诱导）继以BMS-986489维持治疗（A组）与随机分配至阿替利珠单抗联合卡铂 + 依托泊苷治疗4个周期（诱导）继以阿替利珠单抗维持治疗（B组）作为一线治疗的ES-SCLC受试者的总生存期（OS）

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	双盲	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	[["签署书面知情同意书"],["受试者类型和目标疾病特征。a) 受试者必须患有经组织学或细胞学证实的SCLC。患有广泛期疾病的受试者必须存在AJCC第8版IV期疾病（[任何T分期、任何N分期、M1a、M1b或M1c]或T3-4期[任何N分期、任何M分期]，由于多发肺结节过于广泛或肿瘤或淋巴结体积过大而无法包含在可耐受的放疗计划中）。既往接受过放化疗治疗LS-SCLC的受试者，如果其治疗目的为根治性治疗且从末次化疗、放疗或放化疗至随机分组之间至少6个月，则符合入选标准。b) 根据RECIST v1.1标准，受试者必须至少有1个CNS 外的可测量病灶（通过CT 或MRI 测量）。c) 既往接受过放疗的病灶只有在明确有疾病进展的证据且该病灶不是唯一病灶的情况下，才被视为可测量病灶。d) 如果CNS转移无症状且无需立即治疗，或已经接受了治疗且神经功能已缓解至基线水平（与CNS治疗相关的残留体征或症状除外），则CNS转移受试者符合入选标准。此外，受试者必须在随机分组前至少2周已经停用糖皮质激素，或者接受稳定或递减剂量的每日泼尼松（或等效剂量）≤10 mg。随机分组前28天内进行的影像学检查必须显示出CNS病灶的影像学稳定性，并且应在完成任何针对CNS的治疗后进行。e) ECOG体能状态评分为0或1（采用5分量表，数字越高表示残疾程度越高）。f) 根据当地批准的药物说明书和/或机构指南，受试者必须适合接受含铂化疗方案以及含抗PD（L）-1 方案。"],["在签署ICF 时，受试者必须年满18岁或达到当地法定成人年龄"],["生殖状态。参加研究的女性和男性受试者均应遵循方案要求的妊娠预防计划"]]
排除标准	[["疾病情况。a) 未经治疗的症状性CNS转移。CNS转移的症状示例包括但不限于头痛、意识模糊和视力问题。b)软脑膜病变。c)经适当治疗后仍无法控制的胸腔积液。d) 研究者判断，需要紧急放疗或在不久将来可能需要紧急放疗的恶性肿瘤相关的上腔静脉综合征。e) 既往接受过ES-SCLC 系统性治疗。允许使用局部治疗（包括放疗和/或手术）治疗CNS转移。f) 患有活动性、已知或疑似具有临床意义的自身免疫性疾病的受试者。患有I型糖尿病、仅需激素替代治疗的甲状腺功能减退症、无需系统性治疗的皮肤疾病（如白癜风、银屑病或脱发）或在没有外部诱因的情况下预计不会复发的疾病受试者可以入组。g) 患有需要在随机分组前14天内使用糖皮质激素（＞10 mg/天泼尼松等效剂量）或在随机分组前30天内使用其他免疫抑制药物进行系统性治疗的疾病的受试者。如果没有活动性自身免疫性疾病，则允许使用吸入性或局部类固醇，以及肾上腺替代类固醇剂量＞10 mg/天泼尼松等效剂量。h) 需要治疗的并发恶性肿瘤（筛选期间存在），或在随机分组前2年内有既往恶性肿瘤病史且仍处于活动状态（即，既往有恶性肿瘤病史的受试者，如果在随机分组前至少2年已完成治疗且受试者无疾病证据，则符合入选标准）。有既往早期基底/鳞状细胞皮肤癌或非侵袭性或原位癌病史且在任何时间接受过根治性治疗的受试者也符合入选标准。i) 有特发性肺纤维化、药物性肺炎、特发性肺炎、机化性肺炎病史，或筛选时胸部CT 扫描显示活动性肺炎证据。如果病情稳定，允许既往有放射性肺炎病史。j) 严重的不受控制的心血管疾病。k) 在研究药物首次给药前7天内，尽管接受了适当的抗感染治疗，但受试者仍存在不受控制的或活动性全身性真菌、细菌、病毒或其他感染。l) 已知人类免疫缺陷病毒（HIV）阳性，且在过去一年中发生过AIDS定义的机会感染，或目前CD4细胞计数＜350个细胞/μL。m) 研究入组时存在≥2级外周感觉神经病变。n) 受试者无法进行静脉穿刺和/或无法耐受静脉通路。"],["生殖状态。a)处于哺乳期的个体。b)妊娠个体"],["既往/合并治疗。a)无法遵守方案中列出的限制和禁用治疗。b) 在首次研究治疗前2周内接受过治疗研究疾病的补充药物（例如，草药补充剂或中药）治疗。如果在与医学监查员讨论后用作支持性治疗，则允许使用此类药物。c) 在首次研究治疗前30天内接种过任何活疫苗/减毒疫苗。d) 既往接受过抗PD-1、抗PD-L1或抗CTLA-4抗体或任何其他专门针对T细胞共刺激或检查点通路为靶点的抗体或药物治疗。e) 既往接受过抗fuc-GM1治疗或任何其他专门针对以fuc-GM1为靶点的药物治疗。"],["体格检查和实验室检查结果。a)血液学和终末器官功能不全。i.WBC＜2000/μL。ii. 中性粒细胞＜1500/μL。iii. 血小板＜100 ×103/μL（研究药物首次给药前2周内不允许输血以达到阈值）。iv. 血红蛋白＜9.0 g/dL（研究药物首次给药前2周内不允许输血以达到阈值）v. 血清肌酐＞1.5×正常值上限（ULN），除非肌酐清除率≥40mL/min（使用Cockcroft-Gault 公式测量或计算）。vi.天门冬氨酸氨基转移酶（AST）/丙氨酸氨基转移酶（ALT）：＞3.0×ULN。vii. 总胆红素＞1.5×ULN（患有Gilbert综合征的受试者除外，其总胆红素水平必须＜3.0×ULN）。viii.如果乙型肝炎病毒（HBV）检测结果呈阳性，表明存在病毒（例如，HBV DNA阳性），则将被排除。因既往疫苗接种HBsAb阳性的受试者有资格入组。ix.任何丙型肝炎病毒（HCV）的阳性检测结果，表明存在活动性病毒复制（可检测的HCV-RNA）。注：HCV抗体阳性且检测不到HCV RNA的受试者有资格入组。b) 有器官功能障碍的证据或体格检查、生命体征、ECG或临床实验室检查结果与正常值有任何临床显著偏离，超出了目标人群的范围。"],["阳性过敏和药物不良反应。a) 对研究药物的任何成分（包括辅料）或相关化合物有过敏/超敏反应史。"],["其他排除标准。a)囚犯或非自愿被收容的受试者。（注：在特定情况下，且仅在当地法规允许的国家，已被监禁的人可能会作为受试者被纳入或允许继续参加研究。需要遵守严格的条件，且需要获得申办方批准。）b) 因治疗精神或身体疾病（如传染病）而被强制监禁的受试者。"]]

试验药

[["中文通用名:BMS-986489 英文通用名:BMS-986489 商品名称:NA","剂型:注射液 规格:40mgBMS-986012/120mg纳武利尤单抗/2ml/瓶 用法用量:给药途径：静脉输注用量：BMS-986012420mg/纳武利尤单抗360mg、BMS-986012560mg/纳武利尤单抗480mg 用药时程:BMS-986012420mg/纳武利尤单抗360mg，第1-4周期第1天，Q3W（诱导）；BMS-986012560mg/纳武利尤单抗480mg，第5周期及以后第1天，Q4W（维持）"],["中文通用名:卡铂注射液 英文通用名:CarboplatinInjection 商品名称:波贝","剂型:注射液 规格:10ml:100mg 用法用量:给药途径：静脉输注用量：AUC5mg/mL/min 用药时程:第1-4周期第1天，Q3W（仅诱导）"],["中文通用名:依托泊苷注射液 英文通用名:EtoposideInjection 商品名称:NA","剂型:注射液 规格:5ml:0.1g 用法用量:给药途径：静脉输注用量：100mg/m2 用药时程:第1-4周期第1、2、3天，Q3W（仅诱导）"],["中文通用名:依托泊苷注射液 英文通用名:EtoposideInjection 商品名称:NA","剂型:注射液 规格:5ml:0.1g 用法用量:给药途径：静脉输注用量：100mg/m2 用药时程:第1-4周期第1、2、3天，Q3W（仅诱导）"]] 序号 名称 用法

对照药

[["中文通用名:阿替利珠单抗注射液 英文通用名:AtezolizumabInjection 商品名称:泰圣奇","剂型:注射液 规格:1200mg/20ml(60mg/ml) 用法用量:给药途径：静脉输注用量：1200mg、1680mg 用药时程:1200mg，第1-4周期第1天，Q3W（诱导）；1680mg，第5周期及以后第1天，Q4W（维持）"],["中文通用名:卡铂注射液 英文通用名:CarboplatinInjection 商品名称:波贝","剂型:注射液 规格:10ml:100mg 用法用量:给药途径：静脉输注用量：AUC5mg/mL/min,第1-4周期第1天，Q3W（仅诱导） 用药时程:第1-4周期第1天，Q3W（仅诱导）"],["中文通用名:依托泊苷注射液 英文通用名:EtoposideInjection 商品名称:NA","剂型:注射液 规格:5ml:0.1g 用法用量:给药途径：静脉输注用量：100mg/m2 用药时程:第1-4周期第1、2、3天，Q3W（仅诱导）"],["中文通用名:依托泊苷注射液 英文通用名:EtoposideInjection 商品名称:NA","剂型:注射液 规格:5ml:0.1g 用法用量:给药途径：静脉输注用量：100mg/m2,第1-4周期第1、2、3天，Q3W（仅诱导） 用药时程:第1-4周期第1、2、3天，Q3W（仅诱导）"]] 序号 名称 用法

主要终点指标及评价时间	[["总生存期（OS）","直至死亡，LPFV后n最长5年","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	[["恶化时间（TTDD）","直至恶化，LPFV最长五年","有效性指标"],["AE、SAE、导致研究药物停药和死亡AE的发生率","直至研究治疗末次治n疗后135天","安全性指标"],["客观缓解（OR）","直至疾病进展，LPFVn后最长5年","有效性指标"],["缓解持续时间（DOR）","直至疾病进展，LPFVn后最长5年","有效性指标"],["无进展生存期（PFS）","直至疾病进展，LPFVn后最长5年","有效性指标"]] 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	13301825532	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"],["Texas Oncology - Central/South Texas","James Uyeki","美国","TX","Austin"],["SCRI Oncology Partners","Melissa Johnson","美国","TN","Nashville"],["Mid Florida Hematology and Oncology Center","Santosh Nair","美国","FL","Orange City"],["Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital","Steven McCune","美国","GA","Marietta"],["Illinois Cancer Care","Gary MacVicar","美国","IL","Peoria"],["Florida Cancer Specialists - North","Maen Hussein","美国","FL","St. Petersburg"],["Swedish Medical Center","Siddhartha Devarakonda","美国","WA","Seattle"],["Duke Cancer Institute","Neal Ready","美国","NC","Durham"],["University of New Mexico Comprehensive Cancer Center","Moises Harari Turquie","美国","NM","Albuquerque"],["Gustave Roussy","Pernelle Lavaud","法国","Val-de-Marne","Villejuif"],["CHU GRENOBLE ALPES","Denis Moro-Sibilot","法国","Isère","La Tronche"],["Assistance Publique Hopitaux de Marseille - Hopital Nord","Laurent Greillier","法国","NA","Marseille"],["L HOPITAL NORD OUEST","LIONEL FALCHERO","法国","Rhone","GLEIZE"],["Centre Hospitalier Intercommunal de Créteil","Christos Chouaid","法国","Val-de-Marne","Créteil"],["Hopital Arnaud de Villeneuve - CHU Montpellier","Benoit Roch","法国","Hérault","Montpellier"],["Institut Curie","Nicolas Girard","法国","Paris","Paris"],["centre hospitalier lyon sud","Sebastien Couraud","法国","Rhone","Pierre-Bénite"],["CHU Lille - Institut Coeur Poumon","Arnaud Scherpereel","法国","Nord","Lille Cedex"],["European Interbalkan Medical Center","Sofia Baka","希腊","Thessaloníki","Thessaloniki"],["University General Hospital of Larissa","Athanasios Kotsakis","希腊","Thessalía","Larissa"],["Theagenio Cancer Hospital of Thessaloniki","Anastasios Boutis","希腊","Kentrikí Makedonía","Thessaloniki"],["Errikos Dunant Hospital Center","IOANNIS MOUNTZIOS","希腊","Attikí","Athens"],["THORACIC GENERAL HOSPITAL OF ATHENS","Konstantinos Syrigos","希腊","Attikí","Athens"],["Istituto Europeo di Oncologia IRCCS","Filippo de Marinis","意大利","Milano","Milano"],["Fondazione IRCCS Istituto Nazionale dei Tumori","Giuseppe Lo Russo","意大利","Lombardia","Milan"],["Istituto Nazionale Tumori Regina Elena","Federico Cappuzzo","意大利","Roma","Roma"],["Casa di Cura Dott. Pederzoli","ANTONIO SANTO","意大利","Verona","Peschiera del Garda"],["Istituto Nazionale Tumori IRCCS Fondazione Pascale","Alessandro Morabito","意大利","Campania","Napoli"],["IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola","Francesco Gelsomino","意大利","Bologna","Bologna"],["Hospital Italiano de Buenos Aires","Yamila Ferreira","阿根廷","Ciudad Autónoma de Buenos Aires","ABB"],["Instituto Alexander Fleming","Diego Enrico","阿根廷","Buenos Aires","Ciudad Autónoma de Buenos Aires"],["Clinica Adventista Belgrano","Aldo Perfetti","阿根廷","Ciudad Autónoma de Buenos Aires","CABA"],["ONCOCENTRO APYS","Alejandro Acevedo","智利","Valparaíso","Vina del Mar"],["Pontificia Universidad Catolica de Chile","Hector Galindo","智利","Región Metropolitana de Santiago","Santiago"],["Bradfordhill","Carlos Rojas","智利","Región Metropolitana de Santiago","Santiago"],["Fundacion Arturo Lopez Perez (FALP)","Christian Caglevic","智利","Región Metropolitana de Santiago","Santiago"],["Orlandi Oncologia","Francisco Orlandi","智利","Región Metropolitana de Santiago","Santiago"],["UZ Gent","Veerle Surmont","比利时","Oost-Vlaanderen","Gent"],["Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman","Anne Sibille","比利时","NA","Liège"],["Instituto Médico Río Cuarto","Saul Del Grecco","阿根廷","Córdoba","Río Cuarto"],["Amsterdam UMC, locatie VUmc","I Bahce","荷兰","Noord-Holland","Amsterdam"],["University Medical Center Groningen","T.Jeroen Hiltermann","荷兰","NA","Groningen"],["Ziekenhuis Rijnstate","Niels Claessens","荷兰","NA","Arnhem"],["Instituto de Oncología Angel H. Roffo","Monica Castro","阿根廷","Ciudad Autónoma de Buenos Aires","Buenos Aires"],["The Christie NHS Foundation Trust","Raffaele Califano","英国","NA","Manchester"],["Gallipoli Medical Research Ltd","Kenneth O'Byrne","澳大利亚","Queensland","Brisbane"],["Nepean Hospital","Deme Karikios","澳大利亚","New South Wales","Penrith"],["AO Santa Maria della Misericordia","Giulio Metro","意大利","Umbria","Perugia"],["A. C. Camargo Cancer Center","Thiago Oliveira","巴西","Sao Paulo","Sao Paulo"],["Fakultni Thomayerova nemocnice","Marketa Cernovska","捷克","Praha 4","Prague"],["Masarykuv onkologicky ustav","Jan Podhorec","捷克","Brno-město","Brno"],["Fakultni nemocnice Olomouc","Juraj Kultan","捷克","Olomouc","Olomouc"],["Nemocnice AGEL Ostrava - Vitkovice a.s.","Jaromir Roubec","捷克","Ostrava město","Ostrava"],["Institutul Regional de Oncologie","Dana Clement","罗马尼亚","Iasi","Iasi"],["SC Memorial Healthcare International SRL","Ingrid Iordan","罗马尼亚","Bucuresti","Bucharest"],["Institutul Oncologic Bucuresti","Aurelia Alexandru","罗马尼亚","Bucuresti","Bucharest"],["SC Radiotherapy Center Cluj SRL","Andrei Ungureanu","罗马尼亚","Cluj","Floresti"],["S.C. Centrul de Oncologie Euroclinic S.R.L.","Constantin Volovat","罗马尼亚","Iasi","Iasi"],["Centrul de Oncologie “Sfantul Nectarie”","Michael Schenker","罗马尼亚","Dolj","Craiova"],["Institutul Oncologic Cluj","Tudor Ciuleanu","罗马尼亚","Cluj","Cluj"],["Unidad Médica Onco-hematológica","Salvador Macias Diaz","墨西哥","Puebla","Puebla"],["CIO - Centro de Inmuno-Oncología de Occidente","Noel Esaul Luna-Romero","墨西哥","Jalisco","Guadalajara"],["Hospital Universitario","Victor Oyervides Juarez","墨西哥","Nuevo León","Monterrey"],["Istanbul Medeniyet University","Mahmut Gumus","土耳其","Istanbul","Istanbul"],["Adana City Hospital","Timucin Cil","土耳其","Adana","Adana"],["Gulhane Egitim Arastirma Hastanesi","Nuri Karadurmus","土耳其","Ankara","Ankara"],["T.C. Saglik Bakanligi - Izmir Il Saglik Mudurlugu Cigli Bolge Egitim Hastanesi","Murat Akyol","土耳其","Izmir","Cigli"],["Aberdeen Royal Infirmary","Gillian Price","英国","NA","Aberdeen"],["Clínica de Neoplasias Litoral","Giuliano Borges","巴西","Santa Catarina","Itajaí"],["Hospital de Clinicas de Porto Alegre","Rodrigo Pereira","巴西","Rio Grande do Sul","Porto Alegre"],["Hospital Sao Carlos","Fábio Santos","巴西","Ceará","Fortaleza"],["Hospital Sao Lucas da PUCRS","Ana Caroline Gelatti","巴西","Rio Grande do Sul","Porto Alegre"],["Instituto de Oncologia Saint Gallen","Bianca Correa Tabajara Weiss","巴西","Rio Grande do Sul","Santa Cruz do Sul"],["St. John of God Murdoch Hospital","Adeoluwa FREEMAN","澳大利亚","Western Australia","Murdoch"],["Ataturk Gogus Hastallklarl Ve Gogus Cerrahisi Egitim Arastlrma Hastanesi","Serdar Karakaya","土耳其","Ankara","Ankara"],["Fundacao Pio XII - Hospital de Cancer de Barretos","Flavio Augusto Ferreria Da Silva","巴西","Barretos","Sao Paulo"],["James Cook University Hospital","Talal Mansy","英国","Middlesbrough","Central Middlesbrough"],["VITAZ","Koenraad Deschepper","比利时","Oost-Vlaanderen","Sint-Niklaas"],["Instytut Centrum Zdrowia Matki Polki","Ewa Kalinka","波兰","Lodzkie","Lodz"],["Grampians Health","Wasek Faisal","澳大利亚","Victoria","Ballarat Central"],["Szpital Specjalistyczny w Prabutach Spolka z o.o.","Anna Lowczak","波兰","Pomorskie","Prabuty"],["Przychodnia Lekarska KOMED","Boguslawa Karaszewska","波兰","Wielkopolskie","Konin"],["Centrum Onkologii im. Prof. Franciszka Lukaszczyka","Bogdan Zurawski","波兰","NA","Bydgoszcz"],["Cliniques universitaires Saint-Luc","Frank Nana Aboubakar","比利时","Bruxelles-Capitale, Région de","Brussels"],["山东省肿瘤医院","邢力刚","中国","山东省","济南市"],["GenesisCare - Campbelltown","Jessica Smith","大利亚","New South Wales","Campbelltown"],["重庆市肿瘤医院","马惠文","中国","重庆市","重庆市"],["北京大学肿瘤医院","赵军","中国","北京市","北京市"],["上海市胸科医院","钟华","中国","上海市","上海市"],["华中科技大学同济医学院附属同济医院","褚倩","中国","湖北省","武汉市"],["湖北省肿瘤医院","韩光","中国","湖北省","武汉市"],["复旦大学附属中山医院","宋元林","中国","上海市","上海市"],["厦门大学附属第一医院","叶峰","中国","福建省","厦门市"],["天津市肿瘤医院","黄鼎智","中国","天津市","天津市"],["Centre Hospitalier de Cornouaille Quimper - Concarneau","Romain Corre","法国","NA","Quimper"],["湖南省肿瘤医院","邬麟","中国","湖南省","长沙市"],["The Clatterbridge Cancer Centre","Carles Escriu","英国","NA","Wirral"],["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"],["浙江省台州医院","吕冬青","中国","浙江省","台州市"],["Sanford Cancer Center","Allison Watson","美国","SD","Sioux falls"],["南昌大学第一附属医院","张伟","中国","江西省","南昌市"],["汕头大学医学院附属肿瘤医院","林雯","中国","广东省","汕头市"],["辽宁省肿瘤医院","马锐","中国","辽宁省","沈阳市"],["浙江大学附属邵逸夫医院","陈恩国","中国","浙江省","杭州市"],["浙江省肿瘤医院","范云","中国","浙江省","杭州市"],["Centrum Medyczne Pratia Poznań","Marek Kotlarski","波兰","Wielkopolskie","Skorzewo"],["吉林省肿瘤医院","程颖","中国","吉林省","长春市"],["Florida Cancer Specialists - South","Alexander Glick","美国","FL","Fort Myers"],["Oncology & Hematology Associates of Southwest Virginia, Inc.","Jerome Goldschmidt","美国","VA","Roanoke"],["UniversitatsSpital Zürich","Ulrich Richter","瑞士","Zürich","Zürich"],["Kantonsspital Graubünden","Michael Mark","瑞士","NA","Chur"],["Kantonsspital Winterthur","Laetitia Mauti","瑞士","NA","Winterthur"],["Klinikum Wels-Grieskirchen GmbH","Philipp Vinatzer","奥地利","Oberosterreich","Wels"],["Kepler Universitatsklinikum","David Lang","奥地利","NA","Linz"],["Medizinische Universitat Graz","Nikolaus Kneidinger","奥地利","Steiermark","Graz"],["Landeskrankenhaus Rankweil","Thomas Winder","奥地利","NA","Rankweil"],["Institut für Klinisch Onkologische Forschung","Akin Atmaca","德国","Hessen","Frankfurt"],["Zentralklinik Bad Berka","Ekkehard Eigendorff","德国","Thüringen","Bad Berka"],["Asklepios Klinik Gauting GmbH","Niels Reinmuth","德国","NA","Gauting"],["LungenClinic Grosshansdorf","Martin Reck","德国","NA","Grosshansdorf"],["Thoraxklinik-Heidelberg gGmbH","Michael Thomas","德国","NA","Heidelberg"],["Klinikum Koln-Merheim","Eva-Lotte Buchmeier","德国","Nordrhein-Westfalen","Koln"],["Pius Hospital Oldenburg","Frank Griesinger","德国","Niedersachsen","Oldenburg"],["Robert Bosch Krankenhaus GmbH","Martin Kimmich","德国","NA","Stuttgart"],["Krankenhaus Martha-Maria Halle-Dolau","Miriam Moeller","德国","Sachsen-Anhalt","Halle"],["Meenakshi Mission Hospital and Research Centre","Saju SV","印度","Tamil Nadu","Madurai"],["Netaji Subhas Chandra Bose Cancer Hospital","Poulami Basu","印度","West Bengal","Kolkata"],["Manipal Hospitals","Amit Rauthan","印度","Karnataka","Bengaluru"],["Mahamana Pandit Madan Mohan Malviya Cancer Centre","Bipinesh Sansar","印度","Uttar Pradesh","Varanasi"],["All India Institute of Medical Sciences","SACHIN KHURANA","印度","Delhi","New Delhi"],["Texas Oncology - Northeast Texas","Sarah Wang","美国","TX","Tyler"],["Genesis Cancer and Blood Institute","Roy Webb","美国","AR","Hot Springs"],["Oncology Hematology Care","Patrick Ward","美国","OH","Cincinnati"],["Severance Hospital, Yonsei University Health System","Byoung Chul Cho","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["Seoul National University Bundang Hospital","Yu Jung Kim","韩国","Kyonggi-do","Seongnam"],["Centre integre de sante et de services sociaux du Bas Saint-Laurent- Hopital regional de Rimouski","Samuel Nadeau","加拿大","QC","Rimouski"],["IUCPQ","Marie-Helene Denault","加拿大","QC","Quebec"],["Cross Cancer Institute","Quincy Chu","加拿大","Alberta","Edmonton"],["CIUSSS- saguenay-Lac-Saint-Jean","Marc Trudeau","加拿大","Quebec","Chicoutimi"],["Sendai Kousei Hospital","Shunichi Sugawara","日本","Miyagi","Sendai"],["Kurume University Hospital","Koichi Azuma","日本","Fukuoka","Kurume"],["Asan Medical Center","Sang-We Kim","韩国","Seoul-teukbyeolsi [Seoul]","Seoul"],["HOSPITAL CLíNIC DE BARCELONA","Alejandro Navarro Mendivil","西班牙","Catalunya [Cataluna]","Barcelona"],["HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO","Reyes Bernabe Caro","西班牙","Sevilla","SEVILLA"],["Hospital Universitario 12 de Octubre","Luis Paz-Ares Rodriguez","西班牙","Madrid, Comunidad de","Madrid"],["HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA","Mariano Provencio Pulla","西班牙","Madrid, Comunidad de","Majadahonda"],["Hospital Universitario Ramón y Cajal","Maria Eugenia Olmedo Garcia","西班牙","Madrid, Comunidad de","Madrid"],["Hospital Universitario Virgen Macarena","David Vicente Baz","西班牙","Sevilla","Sevilla"],["CHUS - Hospital Clinico Universitario","Jorge Garcia Gonzalez","西班牙","A Coruna [La Coruna]","Santiago de Compostela"],["HOSPITAL UNIVERSITARIO DE JAEN","Ana Laura Ortega Granados","西班牙","Jaén","Jaen"],["Hospital de la Santa Creu i Sant Pau","Margarita Majem Tarruella","西班牙","Catalunya [Cataluna]","Barcelona"],["Hospital General Universitario de Valencia","Paula Espinosa Olarte","西班牙","Valenciana, Comunitat","Valencia"],["Ajou University Hospital","Hyun Woo Lee","韩国","Kyǒnggi-do","Suwon-si"],["Chungbuk National University Hospital","Ki Hyeong Lee","韩国","Chungcheongbuk-do [Chungbuk]","Cheongju-si"],["福建省肿瘤医院","何志勇","中国","福建省","福州市"],["Keimyung University Dongsan Hospital","Keon Uk Park","韩国","Taegu-Kwangyǒkshi","Daegu"],["Hospital Kuala Lumpur","Muthukkumaran Thiagarajan","马来西亚","Wilayah Persekutuan Kuala Lumpur","Kuala Lumpur"],["Sarawak General Hospital","Pei Jye Voon","马来西亚","Sarawak","Kuching"],["University Malaya Medical Centre","Dai Wee Lee","马来西亚","Wilayah Persekutuan Kuala Lumpur","Kuala Lumpur"],["Hokkaido University Hospital","Yasuyuki Ikezawa","日本","Hokkaido","Sapporo"],["Kindai University Hospital- Osakasayama Campus","Takayuki Takahama","日本","Osaka","Osakasayama"],["The Cancer Institute Hospital of JFCR","Ryo Ariyasu","日本","Tokyo","Koto"],["Kanagawa Cardiovascular and Respiratory Center","Satoshi Ikeda","日本","Kanagawa","Yokohama"],["Kansai Medical University Hospital","Takayasu Kurata","日本","Osaka","Hirakata"],["Saitama Prefectural Cancer Center","Hideaki Mizutani","日本","Saitama","Ina-machi"],["National Hospital Organization Shikoku Cancer Center","Takashi Ninomiya","日本","Ehime","Matsuyama"],["Saitama Medical University International Medical Center","Hiroshi Kagamu","日本","Saitama","Hidaka"],["Kanazawa University Hospital","Seiji Yano","日本","Ishikawa","Kanazawa"],["Hamamatsu University Hospital","Naoki Inui","日本","Shizuoka","Hamamatsu"],["Kobe City Medical Center General Hospital","Yuki Sato","日本","Hyogo","Kobe"],["Nara Medical University Hospital","Masayuki Takeda","日本","NARA","Kashihara city"],["Osaka Medical and Pharmaceutical University Hospital","Yasuhito Fujisaka","日本","Osaka","Takatsuki"],["Nippon Medical School Hospital","Kazuo Kasahara","日本","Tokyo","Bunkyo-ku"],["Fukushima Medical University","Hiroyuki Suzuki","日本","Fukushima","Fukushima"],["Kurashiki Central Hospital","Yasushi Fukuda","日本","Okayama","Kurashiki"],["四川省肿瘤医院","李娟","中国","四川省","成都市"],["西安国际医学中心","南克俊","中国","陕西省","西安市"],["北京胸科医院","林根","中国","北京市","北京市"]]

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","2025-01-21"],["上海市东方医院药物/器械临床试验伦理委员会","同意","2025-02-21"]]

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: 73 ； 国际: 530 ；
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；