杭州DS-1062aIII期临床试验-Dato-DXd与Rilvegostomig联合用于高PD-L1表达（TC ≥ 50%）且无可靶向基因改变的非鳞状非小细胞肺癌一线治疗的III期开放标签研究（TROPION-Lung10）

登记号	CTR20250759	试验状态	进行中
申请人联系人	杨瑛	首次公示信息日期	2025-03-05
申请人名称	AstraZeneca AB/ 阿斯利康全球研发（中国）有限公司/ AstraZeneca Nijmegen B.V.; AstraZeneca AB

登记号	CTR20250759
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	非小细胞肺癌
试验专业题目	一项评估Datopotamab Deruxtecan（Dato-DXd）和Rilvegostomig（AZD2936）联合治疗或Rilvegostomig单药治疗相比帕博利珠单抗单药治疗用于PD-L1高表达（TC≥50%）且无驱动基因改变的局部晚期或转移性非鳞状细胞NSCLC受试者一线治疗的随机、开放性、全球III期研究（TROPION-Lung10）
试验通俗题目	Dato-DXd与Rilvegostomig联合用于高PD-L1表达（TC ≥ 50%）且无可靶向基因改变的非鳞状非小细胞肺癌一线治疗的III期开放标签研究（TROPION-Lung10）
试验方案编号	D7632C00001	方案最新版本号	2.0
版本日期:	2024-09-05	方案是否为联合用药	是

申请人名称	[["AstraZeneca AB"],["阿斯利康全球研发（中国）有限公司"],["AstraZeneca Nijmegen B.V.; AstraZeneca AB"]]
联系人姓名	杨瑛	联系人座机	021-61308402	联系人手机号
联系人Email	Clinical-Trial-Disclosure-Mailbox@astrazeneca.com	联系人邮政地址	上海市-上海市-静安区西藏北路88号 阿斯利康全球研发中心	联系人邮编	200085

本研究的目的是评估Dato-DXd与rilvegostomig联合使用或rilvegostomig单药治疗相对于pembrolizumab单药治疗作为一线疗法在局部晚期或转移性高PD-L1表达（TC ≥ 50%）且无可靶向基因改变的非鳞状非小细胞肺癌参与者中的疗效和安全性。

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	[["经组织学或细胞学证实的非鳞状细胞NSCLC。"],["不适合治愈性手术或根治性放化疗的IIIB期或IIIC期或IV期转移性NSCLC（根据美国癌症联合委员会第8版癌症分期系统）"],["无EGFR敏感突变以及ALK和ROS1重排，并且不存在任何其他已知基因组改变的本地测试结果记录，也无当地-批准和可用的一线靶向治疗的可操作驱动癌基因改变。"],["必须提供肿瘤样本来确定PD-L1状态、TROP2状态和其他生物标志物。"],["肿瘤PD-L1表达状态已知，定义为TC≥50%"],["基线时至少存在1处既往未进行过照射的病灶，可作为RECIST 1.1靶病灶。"],["ECOG体能状态评分为0或1。"],["研究干预药物首次给药前7天内有充分的骨髓储备且器官功能良好。"]]
排除标准	[["既往接受过晚期/转移性NSCLC全身治疗。"],["组织学类型为鳞状细胞癌，或以鳞状细胞组织学NSCLC为主；混合性小细胞肺癌；肉瘤样组织学NSCLC。"],["3年内有其他原发性恶性肿瘤病史。"],["活动性或既往有记录的自体免疫性或炎症性疾病（有些除外情况）。"],["任何严重或无法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ILD/肺炎、心脏疾病。"],["具有临床显著的第三间隙液体潴留（例如胸腔积液），且不适合重复引流。"],["有需要类固醇激素治疗的非感染性ILD/非感染性肺炎病史、当前有ILD/非感染性肺炎、或筛选时影像学检查不能排除疑似ILD/非感染性肺炎。"],["由研究者判断的显著肺功能受损。"],["已知脊髓压迫或脑转移，除非参与者接受治疗且不再出现症状、放射学稳定且不需要使用皮质类固醇或抗惊厥药治疗。"],["已知存在软脑膜癌。"],["已知存在具有临床意义的角膜疾病。"],["患有活动性或未控制的乙型肝炎、丙型肝炎，活动性甲型肝炎，已知且控制不佳的艾滋病毒感染。"],["存在活动性原发性免疫缺陷病史。"]]

试验药	[["中文通用名:DS-1062a 英文通用名:Datopotamabderuxtecan 商品名称:NA","剂型:NA 规格:NA 用法用量:每3周静脉注射一次（Q3W）,在每21天周期的第1天。 用药时程:NA"],["中文通用名:AZD2936 英文通用名:AZD2936 商品名称:NA","剂型:NA 规格:NA 用法用量:每3周静脉注射一次（Q3W）,在每21天周期的第1天。 用药时程:NA"]] 序号 名称 用法
对照药	[["中文通用名:帕博利珠单抗 英文通用名:Pembrolizumab 商品名称:可瑞达","剂型:NA 规格:NA 用法用量:每3周静脉注射一次（Q3W）,在每21天周期的第1天。 用药时程:NA"]] 序号 名称 用法

主要终点指标及评价时间

[["TROP2生物标志物阳性参与者的无进展生存期（PFS）。","大约4年","有效性指标"],["在TROP2生物标志物阳性受试者中根据OS评估结果。","大约6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

[["FAS 人群的无进展生存期 (PFS)。","大约4年","有效性指标"],["FAS 人群的总生存率 (OS)。","大约6年","有效性指标"],["通过 BICR 对 TROP2 生物标志物阳性和 FAS 人群的客观缓解率 (ORR) 进行评估。","大约4年","有效性指标"],["使用 BICR 对 TROP2 生物标志物阳性和 FAS 人群的缓解持续时间 (DoR) 进行评估。","大约4年","有效性指标"],["相对于使用 pembrolizumab 治疗，使用 Dato-DXd 联合 rilvegostomig 治疗的参与者报告的 NSCLC 肺癌症状和参与者报告的 GHS/QOL。","大约6年","有效性指标"],["参与者报告了接受 Dato DXd 联合 rilvegostomig 治疗的参与者相对于接受 pembrolizumab 治疗的身体机能情况。","大约6年","有效性指标"],["药代动力学（PK）","大约6年","有效性指标"],["免疫原性","大约6年","有效性指标"],["第二次无进展生存期 (PFS2)。","大约6年","有效性指标"],["评估Dato-DXd与rilvegostomig联合治疗和rilvegostomig单药治疗与帕博利珠单抗相比的安全性。","大约6年","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	范云	学位	博士	职称	主任医师
	电话	13858182310	Email	fanyun@zjcc.org.cn	邮政地址	浙江省-杭州市-拱墅区半山东路1号
	邮编	310005	单位名称	浙江省肿瘤医院

[["浙江省肿瘤医院","范云","中国","浙江省","杭州市"],["上海市胸科医院","李子明","中国","上海市","上海市"],["湖南省肿瘤医院","邬麟","中国","湖南省","长沙市"],["临沂市肿瘤医院","石建华","中国","山东省","临沂市"],["山东第一医科大学附属肿瘤医院","邢力刚","中国","山东省","济南市"],["华中科技大学同济医学院附属协和医院","董晓荣","中国","湖北省","武汉市"],["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"],["江苏省苏北人民医院","汪步海","中国","江苏省","扬州市"],["重庆大学附属肿瘤医院","王春梅","中国","重庆市","重庆市"],["湖北省肿瘤医院","杨彬","中国","湖北省","武汉市"],["北京肿瘤医院","赵军","中国","北京市","北京市"],["台州恩泽医疗中心（集团）","吕冬青","中国","浙江省","台州市"],["中山大学附属第一医院","唐可京","中国","广东省","广州市"],["山西省肿瘤医院","郭伟","中国","山西省","太原市"],["广西医科大学附属肿瘤医院","赵文华","中国","广西壮族自治区","南宁市"],["浙江大学医学院附属邵逸夫医院","方勇","中国","浙江省","杭州市"],["首都医科大学附属北京胸科医院","胡瑛","中国","北京市","北京市"],["江苏省肿瘤医院","沈波","中国","江苏省","南京市"],["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"],["四川省肿瘤医院","周进","中国","四川省","成都市"],["河南省肿瘤医院","王启鸣","中国","河南省","郑州市"],["西安交通大学医学院第一附属医院","姚煜","中国","陕西省","西安市"],["天津医科大学肿瘤医院","陈鹏","中国","天津市","天津市"],["四川大学华西医院","张衍","中国","四川省","成都市"],["复旦大学附属肿瘤医院","王佳蕾","中国","上海市","上海市"],["福建省肿瘤医院","黄韵坚","中国","福建省","福州市"],["温州医科大学附属第一医院","林全","中国","浙江省","温州市"],["济宁市第一人民医院","李捷","中国","山东省","济南市"],["中国医科大学附属盛京医院","郑伟","中国","辽宁省","沈阳市"],["安徽医科大学第二附属医院","赵卉","中国","安徽省","合肥市"],["上海市肺科医院","吴凤英","中国","上海市","上海市"],["杭州市第一人民医院","陈雪琴","中国","浙江省","杭州市"],["武汉市中心医院","卢宏达","中国","湖北省","武汉市"],["郑州大学第一附属医院","郭三星","中国","河南省","郑州市"],["云南省肿瘤医院","杨润祥","中国","云南省","昆明市"],["广西医科大学第一附属医院","卜庆","中国","广西壮族自治区","南宁市"],["甘肃省人民医院","张方","中国","甘肃省","兰州市"],["亞東紀念醫院","張正昱","中国台湾","台湾","新北"],["台北榮民總醫院","陳玉敏","中国台湾","台湾","台北"],["國立臺灣大學醫學院附設醫院","施金源","中国台湾","台湾","台北"],["中國醫藥大學附設醫院","夏德鈞","中国台湾","台湾","台中"],["國立成功大學醫學院附設醫院","李俊慧","中国台湾","台湾","台南"],["長庚紀念醫院林口總院","楊政達","中国台湾","台湾","桃园"],["三軍總醫院","蔡政良","中国台湾","台湾","台北"],["高雄醫學大學附設中和紀念醫院","洪仁宇","中国台湾","台湾","高雄"],["Mater Adult Hospital","Connor O'Leary","澳大利亚","Queensland","South Brisbane"],["Monash Health","Surein Arulananda","澳大利亚","Clayton","Clayton"],["Blacktown Hospital","Adnan Nagrial","澳大利亚","New South Wales","Blacktown"],["Peter MacCallum Cancer Centre","Benjamin Solomon","澳大利亚","Melbourne","Melbourne"],["Border Medical Oncology","Caroline Lum","澳大利亚","Wodonga","Wodonga"],["Sunshine Coast Public University Hospital, Clinical trial oncology 2A","Bryan Chan","澳大利亚","Birtinya","Birtinya"],["Krankenhaus Nord-Klinik Floridsdorf","Maximilian Hochmair","奥地利","Wien","Wien"],["LKH Feldkirch","Thomas Winder","奥地利","Rankweil","Rankweil"],["Universita tsklinikum Krems","Klaus Hackner","奥地利","Krems","Krems"],["Instituto D’Or de Pesquisa e Ensino - Rio de Janeiro","Clarissa Baldotto","巴西","Rio de Janeiro","Rio de Janeiro"],["Hospital do Cancer de Barretos/Fundacao PIO XII","Flavio Augusto Ferreira da Silva","巴西","Sao Paulo","Barretos"],["Liga Norte Riograndense Contra o Cancer","Sulene Oliveira","巴西","Natal","Natal"],["Hospital Nossa Senhora da Conceicao","Gustavo Alves","巴西","Rio Grande do Sul","Porto Alegre"],["Centro de Pesquisa Mackenzie","Ana Claudia Buiar","巴西","Curitiba","Curitiba"],["Irmandade da Santa Casa de Misericórdia de Sao Paulo","Luis Eduardo Moz","巴西","Sao Paulo","Sao Paulo"],["Centro de Pesquisa Viver","Luis Antunes","巴西","Santa Maria","Santa Maria"],["Fundacao Sao Francisco Xavier - Hospital Marcio Cunha (HMC)","Luciano Viana","巴西","Minas Gerais","Ipatinga"],["Instituto do Cancer Brasil Unidade Taubaté","José Márcio Figueiredo","巴西","Taubaté","Taubaté"],["Centro de Pesquisas Oncológicas - CEPON","Yeni Neron","巴西","Florianópolis","Florianópolis"],["BC Cancer Agency","Barbara Melosky","加拿大","Vancouver","Vancouver"],["CIUSSS de la Mauricie-et-du-Centre-du-Québec","Jean-Sebastien Aucoin","加拿大","Trois","Rivieres"],["Centre régional intégré de cancérologie (CRIC)","Marie-Eve Boucher","加拿大","Lévis","Lévis"],["CIUSSS du Saguenay–Lac-Saint-Jean","Marc Trudeau","加拿大","Chicoutimi","Chicoutimi"],["CISSS du Bas-Saint-Laurent/Hopital Régional de Rimouski","Katerine Marquis","加拿大","Rimouski","Rimouski"],["Hopital du Sacre-Coeur de Montreal","Kevin Jao","加拿大","Montreal","Montreal"],["Lakeridge Health Oshawa","Jeffrey Rothenstein","加拿大","Oshawa","Oshawa"],["Jewish General Hospital","Jason Agulnik","加拿大","Montreal","Montreal"],["Saskatoon Cancer Centre","Sunil Yadav","加拿大","Saskatoon","Saskatoon"],["Thoraxklinik Heidelberg gGmbH","Helge Bischoff","德国","Heidelberg","Heidelberg"],["Klinikum Nürnberg Nord","Wolfgang Brückl","德国","Nürnberg","Nürnberg"],["Kliniken Kempten-Oberallgau gGmbH","Christian Schumann","德国","Kempten","Kempten"],["Franziskus - Hospital Harderberg","Petra Hoffknecht","德国","Georgsmarienhütte","Georgsmarienhütte"],["Onkodok GmbH","Philipp Schütt","德国","Gütersloh","Gütersloh"],["All India Institute Of Medical Sciences","Sachin Khurana","印度","Delhi","New Delhi"],["Kingsway Hospital 44, Kingsway","Mukesh Bang","印度","Maharashtra","Nagpur"],["Rajiv Gandhi Cancer Institute & Research Centre","Mansi Sharma","印度","Delhi","New Delhi"],["Bhagwaan Mahaveer Cancer Hospital & Research Centre","Deepak Gupta","印度","Rajasthan","Marg Jaipur"],["Naryana Health","Vivek Agarwala","印度","West Bengal","Kolkata"],["HCG Manavata Cancer Center","Rajnish Nagarkar","印度","Maharashtra","Nashik"],["Venkateshwar Hospitals","Siddharth Sahai","印度","New Delhi","Dwarka"],["Vasantha Subramanian Hospitals","Subramanian Sundaram","印度","Tamil Nadu","Chennai"],["Tochigi Cancer Center","Yoichi Nakamura","日本","Tochigi","Utsunomiya"],["St. Marianna University Hospital","Naoki Furuya","日本","Kanagawa","Ken-Kawasaki"],["National Hospital Organisation Nagoya Medical Center","Masahide Oki","日本","Aichi","Nagoya"],["Tokushima University Hospital","Hirokazu Ogino","日本","Tokushima","Tokushima"],["Osaka Medical and Pharmaceutical University Hospital","Yasuhito Fujisaka","日本","Osaka","Takatsuki"],["National Hospital Organization Hokkaido Cancer Center","Hiroshi Yokouchi","日本","Hokkaido","Sapporo"],["Kitasato University Hospital","Katsuhiko Naoki","日本","Kanagawa","Sagamihara"],["Kouseiren Takaoka Hospital","Kazuhiko Shibata","日本","Toyama","Takaoka"],["National Cancer Center Hospital","Yusuke Okuma","日本","Tokyo","Tokyo"],["Saitama Medical University International Medical Center","Kyoichi Kaira","日本","Saitama","Hidaka"],["Kindai University Hospital","Hidetoshi Hayashi","日本","Osaka","Osakasayama"],["Okayama University Hospital","Eiki Ichihara","日本","Okayama","Okayama"],["Hirosaki University School of Medicine & Hospital","Tomonori Makiguchi","日本","Aomori","Hirosaki"],["National Cancer Center Hospital East","Yoshitaka Zenke","日本","Chiba","Kashiwa"],["Yokohama Municipal Citizen's Hospital","Yukiko Nakamura","日本","Kanagawa","Yokohama"],["Osaka Metropolitan University Hospital","Yoko Tani","日本","Osaka","Osaka"],["Kyushu University Hospital","Isamu Okamoto","日本","Fukuoka","Fukuoka"],["Hiroshima City Hiroshima Citizens Hospital","Hiroyasu Shoda","日本","Hiroshima","Hiroshima"],["Kumamoto University Hospital","Takuro Sakagami","日本","Kumamoto","Kumamoto"],["Fukuoka University Hospital","Fujita Masaki","日本","Fukuoka","Fukuoka"],["Seoul National University Hospital","Dong-Wan Kim","韩国","Seoul","Seoul"],["Severance Hospital","Hye Ryun Kim","韩国","Seoul","Seoul"],["The Catholic University of Korea St. Vincent's Hospital","Byoung Yong Shim","韩国","Gyeonggi","Gyeonggi"],["Gachon University Gil Hospital","Joo Hwan Park","韩国","Incheon","Incheon"],["Ajou University Hospital","Yong Won Choi","韩国","Gyeonggi","Gyeonggi"],["CHA Bundang Medical Center","Joo-Hang Kim","韩国","Gyeonggi","Gyeonggi"],["Samsung Changwon Hospital","Jun Ho Ji","韩国","Gyeongsangnam","Gyeongsangnam"],["Barcelona, H. del Mar, Oncología","Edurne Arriola Aperribay","西班牙","Cataluna-Barcelona","Cataluna-Barcelona"],["Hospital General Universitario de Alicante","Bartomeu Massuti Sureda","西班牙","Alicante","Alicante"],["Hospital Clínico Universitario de Salamanca","Lorena Bellido Hernández","西班牙","Salamanca-Salamanca","Salamanca-Salamanca"],["Akdeniz University Hospital","Sema Sezgin Goksu","土耳其","Antalya","Antalya"],["Sakarya University Training and Research Hospital","Ilhan Hacibekiroglu","土耳其","Sakarya","Adapazarl"],["Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH","Cengiz Karacin","土耳其","Ankara","Ankara"],["Cerrahpasa Medical Oncology","Mustafa Ozguroglu","土耳其","Istanbul","Istanbul"],["St George's University Hospital NHS Foundation Trust","Jason Chow","英国","London","London"],["Royal Cornwall Hospital","Grant Stewart","英国","Cornwall","Truro"],["Chelsea & Westminster Hospital NHS Trust","Thomas Newsom-Davis","英国","London","London"],["Raigmore Hospital","Carol MacGregor","英国","Inverness","Inverness"],["Gloucestershire Hospitals NHS Foundation Trust","Sean Brown","英国","Cheltenham","Cheltenham"],["Royal Preston Hospital","Ruth Board","英国","Lancashire","Preston"],["Cancer & Hematology Centers of Western Michigan","Yuanbin Chen","美国","Grand Rapids","Grand Rapids"],["Millennium Research and Clinical Development","Anirudha Dasgupta","美国","Houston","Houston"],["Virginia Cancer Specialists, PC","Alexander Spira","美国","Leesburg","Leesburg"],["Highlands Oncology Group","Eric Schaefer","美国","Springdale","Springdale"],["The Center for Cancer and Blood Disorders","Ray Page","美国","Fort Worth","Fort Worth"],["Community Clinical Trials","Saleha Sajid","美国","Kingwood","Kingwood"],["The Christ Hospital Cancer Center","Alexander Starodub","美国","Cincinnati","Cincinnati"],["Piedmont Cancer Institute PC","Trevor Feinstein","美国","Atlanta","Atlanta"],["Nebraska Cancer Specialists","Joel Michalski","美国","Omaha","Omaha"],["Northwest Medical Specialists PLLC","Ndegwa Njuguna","美国","Tacoma","Tacoma"],["Avera Cancer Institute","Benjamin Solomon","美国","Sioux Falls","Sioux Falls"],["Profound Research LLC","Faisal Musa","美国","Dearborn","Dearborn"],["Profound Research LLC","Jeffrey Margolis","美国","Farmington Hills","Farmington Hills"],["Virginia Cancer Institute","Purvi Shah","美国","Richmond","Richmond"],["Oncology Hematology West PC dba Nebraska Cancer Specialists","Eric Schaefer","美国","Grand Island","Grand Island"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["浙江省肿瘤医学伦理委员会","同意","2024-10-15"],["浙江省肿瘤医学伦理委员会","同意","2024-11-12"]]

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: 93 ； 国际: 675 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 24 ；
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：2024-04-11；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2024-05-28；
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；