广州DS-1062aIII期临床试验-一项评估Dato-DXd 联合或不联合奥希替尼对比含铂化疗在EGFR 突变阳性的局部晚期或转移性的非小细胞肺癌参与者的疗效和安全性的研究

登记号	CTR20244119	试验状态	进行中
申请人联系人	王加兵	首次公示信息日期	2024-11-01
申请人名称	ASTRAZENECA AB/ 阿斯利康投资（中国）有限公司/ Baxter Oncology GmbH

登记号	CTR20244119
相关登记号	暂无
药物名称	DS-1062a
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	EGFR突变阳性的局部晚期或转移性非小细胞肺癌
试验专业题目	一项在既往奥希替尼治疗过程中出现疾病进展的EGFR 突变阳性局部晚期或转移性非小细胞肺癌参与者中评估Dato-DXd 联合或不联合奥希替尼治疗对比含铂化疗的III 期、开放性、申办者盲态、随机研究（TROPION-Lung15）
试验通俗题目	一项评估Dato-DXd 联合或不联合奥希替尼对比含铂化疗在EGFR 突变阳性的局部晚期或转移性的非小细胞肺癌参与者的疗效和安全性的研究
试验方案编号	D516KC00001	方案最新版本号	2.0
版本日期:	2024-07-03	方案是否为联合用药	是

申请人名称	[["ASTRAZENECA AB"],["阿斯利康投资（中国）有限公司"],["Baxter Oncology GmbH"]]
联系人姓名	王加兵	联系人座机	010-56439560	联系人手机号	13167259705
联系人Email	Jiabing.Wang1@parexel.com	联系人邮政地址	北京市-北京市-朝阳区朝阳门外大街乙12号昆泰国际大厦15层	联系人邮编	100020

本研究旨在评估 Dato-DXd 联合或不联合奥希替尼对比含铂化疗在既往奥希替尼治疗出现疾病进展的EGFRm 局部晚期或转移性 NSCLC 参与者中的疗效。拟定双主要研究终点旨在证明 Dato-DXd 联合和不联合奥希替尼在盲态独立中心审查（BICR）评估的 PFS 方面相较于化疗的优效性。关键次要有效性终点是OS和CNS PFS。还将评估 Dato-DXd 联合或不联合奥希替尼相较于化疗的安全性和耐受性特征。

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	[["患有经组织学或细胞学证实的非鳞状 NSCLC。"],["必须有病历记录显示既往 EGFR 突变的检测结果的证据（已知存在对 EGFR TKI 敏感的EGFRm [Ex19del、L858R、G719X、S768I 或 L861Q]，可单独存在或与其他 EGFR突变同时存在，可能包括 T790M）。"],["有记录显示在辅助，局部晚期或转移性治疗中既往奥希替尼单药治疗（作为最近的治疗线）中出现颅外影像学进展。"],["EGFR TKI 既往治疗线 ≤ 2（奥希替尼是唯一允许的既往第三代 EGFR TKI）。"],["基线时至少有 1 个未经过辐照的病灶符合 RECIST v1.1 TL 标准，且在基线时可被准确测量。"],["WHO/ECOG体能状态为 0 或 1。"],["随机化前 7 天内有足够的骨髓储备和器官功能。"]]
排除标准	[["在出现转移的情况下使用化疗、血管内皮生长因子抑制剂、免疫治疗或任何抗癌治疗。随机化前 12 个月内在无转移的情况下接受过含铂化疗。"],["存在另一种原发性恶性肿瘤病史，但已接受根治性治疗、在研究干预首次给药前2年内无已知活动性疾病且复发潜在风险低的恶性肿瘤的情形除外。"],["有任何严重或未控制的全身性疾病的证据，包括但不限于活动性出血性疾病、活动性感染、活动性间质性肺病/肺炎、心脏病。"],["经研究者判断，有明显的第三间隙液体潴留（如腹水或胸腔积液），并且不适合进行要求的反复引流。"],["有非感染性间质性肺病（ILD）/肺炎病史（包括需要类固醇治疗的放射性肺炎或药物性 ILD）、当前有 ILD/非感染性肺炎或有疑似 ILD/非感染性肺炎，在筛选时无法通过影像学排除。"],["因伴发肺部疾病导致的肺功能严重受损。"],["不稳定的脊髓压迫和/或不稳定的脑转移。"],["有症状性脑转移（包括软脑膜受累）的受试者。"],["具有临床意义的角膜疾病。"],["需要静脉注射抗生素、抗病毒药或抗真菌药治疗的未控制感染、疑似感染或无法排除感染的情况。"],["已知存在未得到良好控制的人类免疫缺陷病毒（HIV）感染。"]]

试验药

[["中文通用名:Dato-DXd 英文通用名:Dato-DXd 商品名称:NA","剂型:注射剂 规格:100mg 用法用量:静脉输注，6mg/kg，每三周一次 用药时程:在每21天周期的第1天给予Dato-DXd，直至出现研究者根据RECISTv1.1确定的影像学进展、不可接受的毒性或符合其他停止标准"],["中文通用名:奥希替尼片 英文通用名:OsimertinibTablet 商品名称:NA","剂型:片剂 规格:80mg;40mg 用法用量:口服，每日一次，每次80mg或40mg（用于剂量减少） 用药时程:每日一次直至出现研究者根据RECISTv1.1确定的影像学进展、不可接受的毒性或符合其他停止标准"]] 序号 名称 用法

对照药

[["中文通用名:培美曲塞 英文通用名:Pemetrexed 商品名称:NA","剂型:注射剂 规格:0.2g/瓶 用法用量:静脉输注，培美曲塞(500mg/m2)，每21天周期的第1天（每3周一次），持续4个周期，然后培美曲塞维持治疗(500mg/m2)，每3周一次 用药时程:给予培美曲塞直至出现研究者根据RECISTv1.1确定的影像学进展、不可接受的毒性或符合其他停止标准。"],["中文通用名:顺铂 英文通用名:Cisplatin 商品名称:NA","剂型:注射剂 规格:5mg/ml,6ml/瓶 用法用量:静脉输注，顺铂(75mg/m2)，每21天周期的第1天（每3周一次），持续4个周期 用药时程:每三周一次，持续4个周期"],["中文通用名:卡铂 英文通用名:Carboplatin 商品名称:NA","剂型:注射剂 规格:0.1g/瓶 用法用量:静脉输注，卡铂(AUC5)，每21天周期的第1天（每3周一次），持续4个周期 用药时程:持续4个周期"]] 序号 名称 用法

主要终点指标及评价时间

[["无进展生存期（PFS）","最长至2.5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

[["总生存期（OS）","最长至3.5年","有效性指标"],["中枢神经系统无进展生存期（CNS PFS）","最长至2.5年","有效性指标"],["客观缓解率（ORR）","最长至2.5年","有效性指标"],["缓解持续时间（DoR）","最长至2.5年","有效性指标"],["无进展生存期-2（PFS-2）","最长至3.5年","有效性指标"],["采用中枢神经系统（CNS）改良版RECIST v1.1标准的客观缓解率（ORR）","最长至2.5年","有效性指标"],["采用中枢神经系统（CNS）改良版RECIST v1.1标准的缓解持续时间（DoR）","最长至2.5年","有效性指标"],["肺部症状恶化时间","最长至3.5年","有效性指标"],["身体功能恶化时间","最长至3.5年","有效性指标"],["全球健康状况（GHS）/生活质量（QoL）恶化时间","最长至3.5年","有效性指标"],["Dato-DXd的药代动力学","最长至3.5年","有效性指标"],["Dato-DXd的免疫原性","最长至3.5年","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	周清	学位	博士	职称	主任医师
	电话	13544561166	Email	zhouqing@gdph.org.cn	邮政地址	广东省-广州市-越秀区惠福西路123号
	邮编	510080	单位名称	广东省人民医院

[["广东省人民医院","周清","中国","广东省","广州市"],["郑州大学第一附属医院","李醒亚","中国","河南省","郑州市"],["中南大学湘雅三医院","刘学文","中国","湖南省","长沙市"],["济南市中心医院","孙美丽","中国","山东省","济南市"],["河南省肿瘤医院","王启鸣","中国","河南省","郑州市"],["南昌大学第二附属医院","刘安文","中国","江西省","南昌市"],["蚌埠医学院第一附属医院","杨燕","中国","安徽省","蚌埠市"],["北京医院","李琳","中国","北京市","北京市"],["北京大学第一医院","聂立功","中国","北京市","北京市"],["北京协和医院","张力","中国","北京市","北京市"],["河北大学附属医院","宋子正","中国","河北省","石家庄市"],["河南省人民医院","仓顺东","中国","河南省","郑州市"],["武汉大学人民医院","宋启斌","中国","湖北省","武汉市"],["淮安市第一人民医院","孟自力","中国","江苏省","淮安市"],["德阳市人民医院","陈兆红","中国","四川省","德阳市"],["天津医科大学总医院","钟殿胜","中国","天津市","天津市"],["北京大学人民医院","穆新林","中国","北京市","北京市"],["临沂市肿瘤医院","石建华","中国","山东省","临沂市"],["河南科技大学第一附属医院","郭艳珍","中国","河南省","洛阳市"],["安徽省立医院","潘跃银","中国","安徽省","合肥市"],["吉林省肿瘤医院","程颖","中国","吉林省","长春市"],["天津医科大学第二医院","王海涛","中国","天津市","天津市"],["浙江省肿瘤医院","范云","中国","浙江省","杭州市"],["北京肿瘤医院","方健","中国","北京市","北京市"],["浙江大学医学院附属第一医院","周建娅","中国","浙江省","杭州市"],["吉林大学第一医院","崔久嵬","中国","吉林省","长春市"],["西南医科大学附属医院","任培荣","中国","四川省","泸州市"],["四川大学华西医院","王可","中国","四川省","成都市"],["赣南医科大学附属医院","施华球","中国","江西省","赣州市"],["湖南省肿瘤医院","张乐蒙","中国","湖南省","长沙市"],["南华大学附属第一医院","艾小红","中国","湖南省","衡阳市"],["汕头大学医学院肿瘤医院","王鸿彪","中国","广东省","汕头市"],["江苏省肿瘤医院","沈波","中国","江苏省","南京市"],["江西省人民医院","姚伟荣","中国","江西省","南昌市"],["上海肺科医院","苏春霞","中国","上海市","上海市"],["Austin Health","Sagun Parakh","Australia","Heidelberg","Victoria"],["Westmead Hospital","Adnan Nagrial","Australia","Westmead","New South Wales"],["Liverpool Hospital","Victoria Bray","Australia","Liverpool","New South Wales"],["St John of God - Subiaco Hospital","Timothy Clay","Australia","Subiaco","Western Australia"],["Princess Alexandra Hospital","Kenneth O'Byrne","Australia","Woolloongabba","Queensland"],["St George Private Hospital","Chee Lee","Australia","Kogarah","New South Wales"],["Port Macquaries Base Hospital","Baerin Houghton","Australia","Port Macquarie","New South Wales"],["GenesisCare - North Shore","Nick Pavlakis","Australia","St. Leonards","New South Wales"],["Az Maria Middelares Gent","Paul Germonpre","Belgium","Oost-Vlaanderen","Gent"],["Grand Hopital de Charleroi - Site Notre-Dame","Benoit Colinet","Belgium","Hainaut","Charleroi"],["Antwerp University Hospital","Reinier Wener","Belgium","Antwerpen","Edegem"],["Jessa Ziekenhuis - Campus Virga Jesse","Kristof Cuppens","Belgium","Limburg","Hasselt"],["Universitair Ziekenhuis Gent","Veerle Surmont","Belgium","Flemish Region","Gent"],["PUCRS - Hospital Sao Lucas","Ana Caroline Gelatti","Brazil","Rio Grande do Sul","Porto Alegre"],["Clinica de Neoplasias Litoral","Giuliano Borges","Brazil","Santa Catarina","Itajai"],["Hospital BP Mirante","Marcos Magalh？es","Brazil","Sao Paulo","Sao Paulo"],["Oncoclinicas Rio de Janeiro S. A.(Centro de Tratamento de Tumores Botafogo)","Pedro De Marchi","Brazil","Rio de Janeiro","Rio de Janeiro"],["Hospital de Cancer de Barretos - Funda？ao Pio XII","Gustavo Pinto","Brazil","Sao Paulo","Barretos"],["Hospital Mae de Deus/Hospital Giovanni Battista","Alan Azambuja","Brazil","Rio Grande do Sul","Porto Alegre"],["Instituto Americas- Rio de Janeiro","Monica Padoan","Brazil","Rio de Janeiro","Rio de Janeiro"],["Instituto D'or de Pesquisa e Ensino","Clarissa Baldotto","Brazil","Rio de Janeiro","Rio de Janeiro"],["Hospital Alemao Oswaldo Cruz (HAOC)","Carlos Teixeira","Brazil","Sao Paulo","Sao Paulo"],["Clinica Reichow","Sandro Reichow","Brazil","Santa Catarina","Blumenau"],["UPCO - Unidade de Pesquisa Clinica em Oncologia LTDA","Marcio Valerio Costa","Brazil","Pelotas","Pelotas"],["McGill University Health Centre - Glen Site","Scott Owen","Canada","Quebec","Montreal"],["Centre Hospitalier Universitaire De Quebec","Marie-Helene Denault","Canada","Quebec","Quebec City"],["William Osler Health Centre - Brampton Civic Hospital","Parneet Cheema","Canada","Ontario","Brampton"],["Southlake Regional Health Centre","Labib Zibdawi","Canada","Ontario","Newmarket"],["University of Toronto - Sunnybrook Health Sciences Centre","Susanna Cheng","Canada","Ontario","Toronto"],["Princess Margaret Hospital","Natasha Leighl","Canada","Ontario","Toronto"],["Institut Bergonie","Sophie COUSIN","France","Gironde","Bordeaux"],["Hopital d'Instruction des Armees Sainte Anne","Olivier Bylicki","France","Toulon","Toulon"],["Centre Hospitalier D'Avignon - Hopital Henri Duffaut - Medecine Interne Onco-Hematolo","Nicolas Cloarec","France","Vaucluse","Avignon"],["ICM Val d'Aurelle - Oncologie Medicale","Quentin THOMAS","France","Herault","Montpellier"],["Institut Gustave Roussy","David Planchard","France","Villejuif","Villejuif"],["Centre Hospitalier Universitaire de Bordeaux","Remi Veillon","France","Aquitaine","Pessac Cedex"],["HA′pital Calmette - Pulmonary - Thoracic Oncology","Alexis Cortot","France","Nord-Pas-de-Calais","Lille"],["Hopital Saint Joseph","Nadia Guezour","France","Ile-de-France","Paris"],["CHU d'ANGERs","Marie Capucine Willemin","France","Angers","Angers"],["Centre Hospitalier de Cornouaille","Romain Corre","France","Finistere","Quimper"],["CHU de Toulouse - Hopital Larrey","Julien Mazieres","France","Toulouse","de Pouvourville"],["Klinikverbund Allgau gGmbH","Christian Schumann","Germany","Bayern","Kempten"],["Franziskus-Hospital Harderberg, Niels-Stensen-Kliniken - Internistische Onkologie und Hamatologie","Petra Hoffknecht","Germany","Niedersachsen","Georgsmarienhutte"],["LungenClinic Grosshansdorf GmbH","Martin Reck","Germany","Schleswig-Holstein","Grosshansdorf"],["Studiengesellschaft Hamato-Onkologie Hamburg","Eckart Laack","Germany","Hamburg","Hamburg"],["Asklepios Klinik Harburg","Claas Wesseler","Germany","Hamburg","Hamburg"],["Thoraxklinik Heidelberg gGmbH am Universitatsklinikum Heidelberg","Helge Bischoff","Germany","Baden-Wurttemberg","Heidelberg"],["Klinikum Nurnberg","Wolfgang Bruckl","Germany","Bayern","Nurnberg"],["Pius-Hospital Oldenburg","Frank Griesinger","Germany","Niedersachsen","Oldenburg"],["Universitat Essen","Marcel Wiesweg","Germany","Nordrhein-Westfalen","Essen"],["South Tees Hospitals NHS Foundation Trust","Talal Mansy","UK","Middlesbrough","Middlesbrough"],["Beatson West of Scotland Cancer Centre","Nicola Steele","UK","Scotland","Glasgow"],["Leicester Royal Infirmary-University Hospitals of Leicester","Meera Chauhan","UK","Leicester","Leicester"],["The Christie NHS Foundation Trust - Christie Hospital","Raffaele Califano","UK","Manchester","Manchester"],["Barts Health NHS Trust - St Bartholomew's Hospital","Farah Lim","UK","London","London"],["Birmingham Heartlands Hospital","Shobhit Baijal","UK","Birmingham","Birmingham"],["Addenbrooke's Hospital","Philip Earwaker","UK","Cambridgeshire","Cambridge"],["St. Luke's Hospital S.A.","Ippokratis Korantzis","Greece","Thessaloniki","Thessaloniki"],["Henry Dunant Hospital Center","Giannis Mountzios","Greece","Attiki","Athens"],["St. Luke's Hospital S.A.","Eleni Fountzila","Greece","Thessaloniki","Thessaloniki"],["University of Athens Medical School - Sotiria Regional Chest Diseases Hospital of Athens","Konstantinos Syrigos","Greece","Attiki","Athens"],["Athens Medical Center S.A","Sofia Baka","Greece","Thessaloniki","Thessaloniki"],["Ruby Hall Clinic","Minish Jain","India","Maharashtra","Pune"],["Sanjeevani CBCC USA Cancer Hospital","Rakesh Mishra","India","Chhattisgarh","Raipur"],["Bharath Hospital & Institute of Oncology","K. Srinivas","India","Karnataka","Mysore"],["Cancer Hospital foundation","Rajendra Arora","India","Maharashtra","Amravati"],["Indo-American Cancer & Research Centre","Ayyagari Santa","India","Hyderabad","Hyderabad"],["Regional Cancer Centre (RCC) - Thiruvathapuram","Anoop Manoharan","India","Kerala","Thiruvathapuram"],["Kolhapur Cancer Centre (KCC)","Nilesh Dhamne","India","Maharashtra","Karveer"],["Bhaktivedanta Hospital and Research Institute","Nirmal Raut","India","Maharashtra","Thane"],["Thangam Cancer Center - Namakkal","Bhavesh Poladia","India","Tamil Nadu","Namakkal"],["GBH General Hospital & GBH Memorial Cancer Hospital","Rohit Rebello","India","Rajasthan","Udaipur"],["All India Institute of Medical Sciences","Deepak Kumar Das","India","Orissa","Bhubaneshwar"],["Tata Memorial Centre (TMC) - Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC)","Bipinesh Sansar","India","Uttar Pradesh","Ghazipur"],["Shaare Zedek Medical center","Nir Peled","Israel","Yerushalayim","Jerusalem"],["Assuta Medical Center","Elizabeth Dudnik","Israel","Tel-Aviv","Tel Aviv-Yafo"],["Meir Medical Center","Maya Gottfried","Israel","Jerusalem","Jerusalem"],["Soroka University Medical Center","Julia Dudnik","Israel","HaDarom","Beer Sheva"],["The Chaim Sheba Medical Center","Jair Bar","Israel","HaMerkaz","Tel Hashomer"],["Fondazione IRCCS San Gerardo dei Tintori","Diego Cortinovis","Italy","Monza e Brianza","Monza"],["Azienda Ospedaliero-Universitaria San Luigi Gonzaga","Silvia Novello","Italy","Torino","Orbassano"],["Humanitas Mirasole S.p.A.","Luca Toschi","Italy","Milano","Rozzano"],["Azienda Ospedaliero Universitaria Parma","Marcello Tiseo","Italy","Parma","Parma"],["IOV, IRCCS","Laura Bonanno","Italy","Padova","Padova"],["Regina Elena, Istituto Nazionale dei Tumori , IFO, IRCCS","Federico Cappuzzo","Italy","Roma","Roma"],["Istituto Tumori Giovanni Paolo II IRCCS","Domenico Galetta","Italy","Bari","Bari"],["Istituto Nazionale dei Tumori IRCCS - Fondazione Pascale","Alessandro Morabito","Italy","Napoli","Napoli"],["Istituto Europeo Di Oncologia S.r.l.","Antonio Passaro","Italy","Milano","Milano"],["Ospedale Santa Maria della Misericordia, AO di Perugia","Giulio Metro","Italy","Perugia","Perugia"],["Humanitas Istituto Clinico Catanese S.p.A.","Carlo Carnaghi","Italy","Catania","Misterbianco"],["Kanagawa Cardiovascular and Respiratory Center","Satoshi Ikeda","Japan","Kanagawa","Yokohama"],["Osaka City General Hospital - Clinical Oncology","Haruko Daga","Japan","Osaka","Osaka"],["Osaka International Cancer Institute - Respiratory Medicine","Motohiro Tamiya","Japan","Osaka","Osaka"],["Wakayama Medical University Hospital","Hiroaki Akamatsu","Japan","Wakayama","Wakayama"],["Aichi Cancer Center Hospital","Yutaka Fujiwara","Japan","Aichi","Nagoya"],["Sendai Kousei Hospital","Shunichi Sugawara","Japan","Miyagi","Sendai"],["The Cancer Institute Hospital of JFCR","Noriko Yanagitani","Japan","Tokyo","Tokyo"],["Kobe Minimally Invasive Cancer Center","Akito Hata","Japan","Hyogo","Kobe"],["National Hospital Organization Iwakuni Clinical Center","Shoichi Kuyama","Japan","Yamaguchi","Iwakuni"],["Kindai University Hospital","Junko Tanizaki","Japan","Osaka","Osakasayama"],["Nagoya University Hospital - Clinical Oncology & Chemotherapy","Ichidai Tanaka","Japan","Aichi","Nagoya"],["Shikoku Cancer Center","Toshiyuki Kozuki","Japan","Ehime","Matsuyama"],["Kyushu University Hospital - Respiratory Medicine","Isamu Okamoto","Japan","Fukuoka","Fukuoka"],["Kumamoto University Hospital","Takuro Sakagami","Japan","Kumamoto","Kumamoto"],["Niigata Cancer Center Hospital - Internal Medicine","Satoru Miura","Japan","Niigata","Niigata"],["Tochigi Cancer Center - Respiratory medicine","Yoichi Nakamura","Japan","Tochigi","Utsunomiya"],["Fujita Health University Hospital","Masashi Kondo","Japan","Aichi","Toyoake"],["Juntendo Hospital - Respiratory Medicine","Taichi Miyawaki","Japan","Tokyo","Tokyo"],["Kyoto Prefectural University of Medicine","Tadaaki Yamada","Japan","Kyoto","Kyoto"],["Saitama Medical University Hospital","Kyoichi Kaira","Japan","Saitama","Hidaka"],["Kanagawa Cancer Center Hospital","Seigo Katakura","Japan","Kanagawa","Yokohama"],["Shizuoka Cancer Center","Kazushige Wakuda","Japan","Shizuoka","Shizuoka"],["Hospital Canselor Tuanku Muhriz UKM","Fuad Ismail","Malaysia","Cheras, Kuala Lumpur","Wilayah Persekutuan Kuala Lumpur"],["Sunway Medical Center","Boon Khaw Lim","Malaysia","Petaling Jaya","Petaling Jaya"],["Hospital Umum Sarawak","Pei Jye Voon","Malaysia","Kuching","Sarawak"],["Beacon Hospital","Azura Rozila Ahmad","Malaysia","Petaling Jaya","Selangor"],["University Malaya Medical Centre","Yong Kek Pang","Malaysia","Kuala Lumpur","Wilayah Persekutuan Kuala Lumpur"],["Hospital Sultanah Bahiyah","Arvindran Alaga","Malaysia","Alor Setar","Kedah"],["Sunway Medical Centre Penang","Soon Keat Cheah","Malaysia","Pusat Bandar Seberang Jaya, Perai","Pulau Pinang"],["Hospital Sultan Ismail","Rangasamy Ramachandran","Malaysia","Johor Bharu","Johor"],["St. Luke's Medical Center","Rubi Li","Philippines","National Capital Region","Quezon"],["Cardinal Santos Medical Center","Maria Luisa Tiambeng","Philippines","National Capital Region","San Juan"],["University of the Philippines","Jennifer Sandoval-Tan","Philippines","National Capital Region","Manila"],["Riverside Medical Center, Inc.","Adonis Guancia","Philippines","Negros Occidental","Bacolod"],["Metro Davao Medical and Research Center Inc.","Arthur Gregory Lui","Philippines","Davao del Sur","Davao"],["Lung Center Of The Philippines","Marcelo Severino Imasa","Philippines","National Capital Region","Quezon"],["Chong Hua Hospital","Matthew Yap","Philippines","Cebu","Cebu"],["Instytut MSF Sp. z o.o.","Ewa Kalinka","Poland","Lodzkie","Lodz"],["Pratia MCM Krakow","Anna Drosik-Kwasniewska","Poland","Malopolskie","Krakow"],["Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. E. i J. Zeylandow","Katarzyna Stencel","Poland","Wielkopolskie","Poznan"],["Pratia Onkologia Katowice","Agata Kachel - Flis","Poland","Katowice","Katowice"],["Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie","Jaroslaw Kolb - Sielecki","Poland","Olsztyn","Olsztyn"],["Chungbuk National University Hospital","Ki Hyeong Lee","South Korea","Chungcheongbuk-do","Cheongju-si"],["Gyeongsang National Universtiy Hospital","Gyeong-Won Lee","South Korea","Gyeongsangnam-do","Jinju-si"],["Severance Hospital, Yonsei University Health System","Hye Ryun Kim","South Korea","Seoul","Seoul"],["The Catholic University of Korea, St. Vincent's Hospital","Byoung Yong Shim","South Korea","Gyeonggi-do","Suwon-si"],["Inje University Haeundae Paik Hospital","Sung Sook Lee","South Korea","Busan","Busan"],["Samsung Medical Center","Myung-Ju Ahn","South Korea","Seoul","Seoul"],["National Cancer Center","Ji-Youn Han","South Korea","Gyeonggi-do","Goyang-si"],["Seoul National University Bundang Hospital","Yu Jung Kim","South Korea","Gyeonggi-do","Seongnam-si"],["The Catholic University of Korea, Seoul St. Mary's Hospital","Jin Hyoung Kang","South Korea","Seoul","Seoul"],["Asan Medical Center","Sang-We Kim","South Korea","Seoul","Seoul"],["Seoul National University Hospital","Tae Min Kim","South Korea","Seoul","Seoul"],["National Cancer Centre Singapore","Wan Ling Tan","Singapore","South West","Singapore"],["Tan Tock Seng Hospital - Oncology","Samol Jens","Singapore","Central Singapore","Singapore"],["Icon Cancer Centre","Wen Son Hsieh","Singapore","Central Singapore","Singapore"],["Hospital de La Santa Creu i Sant Pau","Margarita Majem Tarruella","Spain","Barcelona","Barcelona"],["Institut Catala D'oncologia","Ernest Nadal Alforja","Spain","Barcelona","L'Hospitalet De Llobregat"],["Hospital Del Mar","Edurne Arriola Aperribay","Spain","Catalunya","Barcelona"],["Complexo Hospitalario Universitario De Santiago","Jorge Jose Garcia Gonzalez","Spain","A Coruna","Santiago De Compostela"],["Complexo Hospitalario Universitario A Coru？a","Maria Rosario Garcia Campelo","Spain","Galicia","A Coruna"],["Hospital Clinico Universitario De Valencia","Paloma Martin Martorell","Spain","Valencia","Valencia"],["Hospital Universitario y Politecnico de La Fe","Oscar Juan Vidal","Spain","Valencia","Valencia"],["Hospital Universitario Marques de Valdecilla","Marta Lopez-Brea Piqueres","Spain","Cantabria","Santander"],["Hospital Quironsalud Malaga","Manuel Cobo Dols","Spain","Malaga","Malaga"],["Hospital Universitario Puerta De Hierro De Majadahonda","Mariano Provencio Pulla","Spain","Madrid","Majadahonda"],["Hospital Universitario Virgen de Valme","Jose Fuentes Pradera","Spain","Sevilla","Sevilla"],["National Taiwan University Hospital","Jin-Yuan Shih","中国台湾","Taipei","Taipei"],["Taipei Veterans General Hospital","Yuh-Min Chen","中国台湾","Taipei","Taipei"],["National Cheng Kung University Hospital","Chien-Chung Lin","中国台湾","Tainan City","Tainan"],["Taichung Veterans General Hospital","Tsung-Ying Yang","中国台湾","Taichung City","Taichung"],["Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare","Kang-Yun Lee","中国台湾","New Taipei City","New Taipei City"],["Changhua Christian Medical Foundation Changhua Christian Hospital","Sheng-Hao Lin","中国台湾","Changhua County, Changhua City","Changhua"],["Chi Mei Medical Center - Liouying","Cheng-Yao Lin","中国台湾","Tainan City","Tainan"],["Taipei Medical University - Taipei Medical University Hospital","Shih-Hsin Hsiao","中国台湾","Taipei City","Taipei"],["Kaohsiung Medical University - Chung-Ho Memorial Hospital","Jen-Yu Hung","中国台湾","Kaohsuing City","Kaohsuing City"],["Khon Kaen University- Faculty of Medicine","Aumkhae Sookprasert","Thailand","Muang Khon Kaen","Muang Khon Kaen"],["King Chulalongkorn Memorial Hospital [Medical Oncology]","Piyada Sitthideatphaiboon","Thailand","Bangkok","Bangkok"],["Siriraj Hospital","Pongwut Danchaivijitr","Thailand","Krung Thep Maha Nakhon [Bangkok]","Bangkok"],["Maharaj Nakorn Chiangmai Hospital","Chaiyut Charoentum","Thailand","Chiang Mai","Chiangmai"],["Rajvithi Hospital","Kunlatida Maneenil","Thailand","Krung Thep Maha Nakhon [Bangkok]","Bangkok"],["Prince of Songkla University","Arunee Dechaphunkul","Thailand","Songkhla","Songkhla"],["Thammasat University Hospital","Hataiwan Ratanabunjerdkul","Thailand","Pathum Thani","Pathumthani"],["NYU Langone Health","Elaine Shum","US","New York","New York"],["Memorial Sloan-Kettering Cancer Center - Medicine, Thoracic Oncology","Helena Yu","US","New York","New York"],["Highlands Oncology Group, PA","Eric Schaefer","US","Arkansas","Springdale"],["Henry Ford Hospital - Internal Medicine","Fawzi Abu Rous","US","Michigan","Detroit"],["American Oncology Partners, PA","Ralph Boccia","US","Maryland","Bethesda"],["Summit Medical Group","Sarada Gurubhagavatula","US","New Jersey","Florham Park"],["VCS","Alexander Spira","US","Virginia","Arlington"],["UC San Diego Moores Cancer Center","Lyudmila Bazhenova","US","California","La Jolla"],["NorthShore University Health System","Nicholas Campbell","US","Illinois","Evanston"],["University Blood & Cancer Center, LLC","Amanda Hathaway","US","Georgia","Athens"],["University of Arizona Cancer Center","Ricklie Julian","US","Arizona","Tucson"],["University of Maryland M & SG CCC","Katherine Scilla","US","Maryland","Baltimore"],["Hanoi Oncology Hospital","Gia Nguyen","Vietnam","Hanoi","Hanoi"],["Vietnam National Cancer Hospital","Van Tu Dao","Vietnam","Hanoi","Hanoi"],["National Lung Hospital","Luong Dinh","Vietnam","Hanoi","Hanoi"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["广东省人民医院伦理审查委员会","同意","2024-09-09"]]

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: 130 ； 国际: 630 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 1 ；
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：2024-10-04；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2024-10-25；
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；