长春PM8002注射液III期临床试验-BNT327研究性治疗联合化疗在未经治疗的小细胞肺癌患者中的安全性和有效性

登记号	CTR20251195	试验状态	进行中
申请人联系人	杨灵凤	首次公示信息日期	2025-04-01
申请人名称	普米斯生物技术（珠海）有限公司

登记号	CTR20251195
相关登记号	CTR20231002
药物名称	PM8002注射液
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	一项在一线广泛期小细胞肺癌受试者中比较BNT327联合化疗（依托泊苷/卡铂）与阿替利珠单抗联合化疗（依托泊苷/卡铂）的III 期、多研究中心、双盲、随机研究
试验通俗题目	BNT327研究性治疗联合化疗在未经治疗的小细胞肺癌患者中的安全性和有效性
试验方案编号	BNT327-03	方案最新版本号	V4.0
版本日期:	2024-11-05	方案是否为联合用药	是

申请人名称	[["普米斯生物技术（珠海）有限公司"]]
联系人姓名	杨灵凤	联系人座机	021-52831708	联系人手机号	19921686399
联系人Email	lillian.yang@biontech.com	联系人邮政地址	上海市-上海市-静安区石门一路288号一座34层3401	联系人邮编	200041

根据ITT 集的OS 风险比，比较BNT327 联合化疗（依托泊苷加卡铂）及任何后续治疗与阿替利珠单抗联合化疗（依托泊苷加卡铂）及任何后续治疗的有效性。

试验分类	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	[["在开始任何试验特定程序之前，根据ICH GCP和当地法律的要求，能够并且已经给出书面知情同意。"],["愿意并能够遵循计划的访视、治疗计划、计划的试验评估、实验室检查、生活方式限制以及试验的其他要求。"],["给予知情同意时年龄≥18岁。"],["经组织学或细胞学证实患有ES-SCLC。"],["既往未接受过ES-SCLC全身性治疗。"],["根据RECIST v1.1，存在至少一个可测量病灶作为靶病灶。"],["ECOG体能状态评分为0或1。"],["最短预期寿命>3个月。"],["方案定义的充分的血液学和器官功能。"],["首次IMP给药前7天内筛选时血清β-人绒毛膜促性腺激素试验结果呈阴性的POCBP。"],["同意从筛选访视开始持续至IMP末次给药后6个月采取高效避孕措施的POCBP、同意采取高效避孕方法的男性以及同意不捐赠和/或冷冻保存生殖细胞。"]]
排除标准	[["已怀孕或正在哺乳，或计划在研究期间或IMP末次给药后6个月内怀孕或者让伴侣怀孕。"],["拥有研究者认为参加试验会损害健康，或能够妨碍、限制或混淆研究方案规定评估或程序，或会影响遵守研究方案要求的医疗、心理或社会状况。"],["患有经组织学或细胞学证实的合并各种组织学类型的SCLC。"],["在接受研究药物前的指定时间间隔内接受过以下任何治疗或药物：n1）2周内：半衰期<7天的小分子药物；不涉及胸腔的放疗；允许对脑部病变进行局部放疗；允许对骨骼病变进行局部放疗。n2）4周内：胸腔放疗；半衰期≥7天的小分子靶向药物；单克隆抗体、抗体-药物偶联物、放射免疫偶联物或T细胞或其他基于细胞的治疗。n3）既往接受过PD (L) - 1/VEGF双特异性抗体治疗。n4）在开始接受研究药物前10天内接受过全身性皮质类固醇（剂量大于10 mg/日泼尼松或同等剂量的其他皮质类固醇）。n5）在开始实验治疗前四周内接种过减毒活疫苗。n6）在开始接受研究药物前2周内接受广谱静脉注射抗生素治疗。n7）在开始接受研究药物之前3周内使用任何研究性产品或正在参与另一项干预性临床试验的有效治疗阶段。"],["在接受研究药物前28天内接受过重大器官手术（允许在试验开始前>7天进行空芯针穿刺活检）、严重创伤或侵入性牙科手术（如牙科植入物），或计划在试验期间进行择期手术。允许放置血管输液装置。"],["接受过异基因造血干细胞移植或器官移植。"],["有方案规定的中枢神经系统转移。"],["有活动性自身免疫性疾病或有预期复发的自身免疫性疾病医学史（如系统性红斑狼疮、类风湿性关节炎、血管炎等），临床稳定的自身免疫性甲状腺疾病或1型糖尿病受试者除外。"],["在接受研究药物前4 年内患有其他恶性肿瘤。已通过局部治疗治愈的患者除外n（例如皮肤基底细胞癌或鳞状细胞癌、浅表性或非浸润性膀胱癌、宫颈原位癌、n乳腺导管原位癌、甲状腺乳头状癌和早期前列腺癌）。"],["在接受研究药物前6个月内有方案规定的心脏疾病。"],["在接受研究药物前有方案规定的高血压或糖尿病。"],["有严重的未愈合伤口、溃疡或骨折。"],["有重大凝血障碍或其他重大出血风险的证据。"],["不受控制的胸腔积液、心包积液或需要反复引流手术的腹水（每月一次或更频繁）。"],["有导致既往免疫治疗停药的3级或3级以上严重免疫相关不良事件史。"],["已知或怀疑会对研究药物（包括其中的任何活性成分或辅料）产生超敏反应。"],["已知患有人免疫缺陷病毒感染或已知患有获得性免疫缺陷综合征。"],["患有活动性乙肝。但是，既往乙肝病毒感染或乙肝病毒感染已消退的受试者只有在乙肝病毒DNA 为阴性时才有资格参加试验。"],["有活动性丙肝病毒感染。已完成根治性抗病毒治疗且丙肝病毒载量低于定量限的n个体允许参加试验。"],["接受既往抗肿瘤治疗时出现过不良事件且这些不良事件未恢复到1 级或以下的受试者不符合本试验的资格。"],["患有上腔静脉综合征或有脊髓压迫症状。"],["有需要使用类固醇治疗的活动性肺部炎症或有该病史，或有活动性间质性肺病，或有间质性肺病病史。有肺纤维化病史，或目前被诊断患有间质性肺炎、尘肺病、化学性肺炎等重度肺部疾病，或任何其他导致肺功能严重受损的疾病。"],["患有活动性结核病或患有活动性梅毒感染。"],["有基础疾病可能会增加联合治疗的风险或使AE 的解释变得复杂（根据研究者判断），或研究者认为受试者不适合参加试验的其他情况。"],["弱势个体。"]]

试验药

[["中文通用名:PM8002注射液 英文通用名:PM8002Injection 商品名称:NA","剂型:注射液 规格:10ml:200mg/瓶 用法用量:静脉滴注。2000mg或1400mg。每3周为1个周期给药1次。 用药时程:最长2年。"],["中文通用名:卡铂10mg/ml输注用浓缩液 英文通用名:CarboplatinHikma10mg/mlConcentrateforsolutionforinfusion 商品名称:Carboplatin","剂型:输注用浓缩液 规格:450mg/45ml 用法用量:静脉给药。AUC5:AUC5mg/mL/min,总剂量≤750mg。每3周为1个周期给药1次。 用药时程:4个周期。"],["中文通用名:依托泊苷20mg/ml输注用浓缩液 英文通用名:EtoposideHikma20mg/mlconcentrateforsolutionforinfusion 商品名称:Etoposide","剂型:输注用浓缩液 规格:200mg/10ml 用法用量:静脉给药。第1~3日:100mg/m^2/天。每3周为1个周期给药1次。 用药时程:4个周期。"]] 序号 名称 用法

对照药

[["中文通用名:阿替利珠单抗1200mg输注用浓缩液 英文通用名:Atezolizumab1200mgconcentrateforsolutionforinfusion 商品名称:泰圣奇","剂型:输注用浓缩液 规格:1200mg/20ml 用法用量:静脉滴注。1200mg。每3周为1个周期给药1次。 用药时程:最长2年。"],["中文通用名:卡铂10mg/ml输注用浓缩液 英文通用名:CarboplatinHikma10mg/mlConcentrateforsolutionforinfusion 商品名称:Carboplatin","剂型:输注用浓缩液 规格:450mg/45ml 用法用量:静脉给药。AUC5:AUC5mg/mL/min,总剂量≤750mg。每3周为1个周期给药1次。 用药时程:4个周期。"],["中文通用名:依托泊苷20mg/ml输注用浓缩液 英文通用名:EtoposideHikma20mg/mlconcentrateforsolutionforinfusion 商品名称:Etoposide","剂型:输注用浓缩液 规格:200mg/10ml 用法用量:静脉给药。第1~3日:100mg/m2/天。每3周为1个周期给药1次。 用药时程:4个周期。"]] 序号 名称 用法

主要终点指标及评价时间

[["总生存期(OS)","从随机分组至因任何原因死亡的时间","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(PFS)","从随机分组至首次客观肿瘤进展（根据RECIST v1.1 评估的疾病进展），或因任何原因死亡的时间，以较早者为准。","有效性指标"],["客观缓解率(ORR)","观察到的CR 或PR（基于研究者根据RECIST v1.1 的评估）为确认的最佳总体缓解的受试者比例。","有效性指标"],["PFS和OS比率","研究者在第6、12、18 个月评估的PFS 率。n在第6、12、18 和24 个月评估的OS 率。","有效性指标"],["治疗中出现的不良事件(TEAE)发生率","从IMP 首次给药至90 天随访访视期间，根据nNCI CTCAE v5.0 分级并按相关性列出的TEAE的发生n率。n因TEAE（包括相关TEAE）延迟给药、中断n输注和中止IMP 治疗的发生率。","安全性指标"],["患者报告的生活质量评分","EORTC QLQ-C30、QLQ-LC29 和NSCLC-SAQ评分较基线的变化","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	程颖	学位	医学博士	职称	主任医师
	电话	0431-80596003	Email	jl.cheng@163.com	邮政地址	吉林省-长春市-高新区锦湖大路1066号
	邮编	130012	单位名称	吉林省肿瘤医院

[["吉林省肿瘤医院","程颖","中国","吉林省","长春市"],["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","赵艳秋","中国","河南省","郑州市"],["临沂市肿瘤医院","石建华","中国","山东省","临沂市"],["首都医科大学附属北京友谊医院","曹邦伟","中国","北京市","北京市"],["河北大学附属医院","商琰红","中国","河北省","保定市"],["复旦大学附属肿瘤医院","王佳蕾","中国","上海市","上海市"],["苏州大学附属第一医院","穆传勇","中国","江苏省","苏州市"],["湖南省肿瘤医院","罗永忠","中国","湖南省","长沙市"],["温州医科大学附属第一医院","杨莉","中国","浙江省","温州市"],["浙江省肿瘤医院","范云","中国","浙江省","杭州市"],["重庆大学附属三峡医院","任必勇","中国","重庆市","重庆市"],["武汉大学中南医院","谢丛华","中国","湖北省","武汉市"],["南昌大学第一附属医院","左玮","中国","江西省","南昌市"],["浙江省台州医院","吕冬青","中国","浙江省","台州市"],["襄阳市中心医院","易铁男","中国","湖北省","襄阳市"],["山东省肿瘤医院(山东第一医科大学附属肿瘤医院、山东省肿瘤防治研究院)","孟祥姣","中国","山东省","济南市"],["江苏省人民医院(南京医科大学第一附属医院)","高雯","中国","江苏省","南京市"],["苏北人民医院","汪步海","中国","江苏省","扬州市"],["中国医学科学院北京协和医院","王孟昭","中国","北京市","北京市"],["北京大学肿瘤医院云南医院/云南省肿瘤医院/昆明医科大学第三附属医院","杨润祥","中国","云南省","昆明市"],["广西医科大学附属肿瘤医院（广西壮族自治区肿瘤医院）","宁瑞玲","中国","广西壮族自治区","南宁市"],["汕头大学医学院附属肿瘤医院","林雯","中国","广东省","汕头市"],["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"],["福建省肿瘤医院","黄韵坚","中国","福建省","福州市"],["蚌埠医学院第一附属医院","杨燕","中国","安徽省","蚌埠市"],["山西省肿瘤医院","宋霞","中国","山西省","太原市"],["哈尔滨医科大学附属肿瘤医院","刘宝刚","中国","黑龙江省","哈尔滨市"],["新乡医学院第一附属医院","姬颖华","中国","河南省","新乡市"],["佳木斯市结核病医院（佳木斯市肿瘤医院）","孙红梅","中国","黑龙江省","佳木斯市"],["首都医科大学附属北京胸科医院","张同梅","中国","北京市","北京市"],["中国科学技术大学附属第一医院（安徽省立医院）","王勇","中国","安徽省","合肥市"],["中国医学科学院肿瘤医院","李宁","中国","北京市","北京市"],["上海市胸科医院","储天晴","中国","上海市","上海市"],["Icon Cancer Centre Kurralta Park","Anna Mislang","Australia","South Australia","Kurralta Park"],["Calvary Mater Newcastle - Research at Calvary Mater Newcastle","Ina Nordman","Australia","Tasmania","Waratah"],["Cancer Care Wollongong Pty Limited","Daniel Paul Brungs","Australia","New South Wales","Wollongong"],["Austin Hospital","Sagun Parakh","Australia","Victoria","Heidelberg"],["Peninsula & South Eastern Haematology and Oncology Group","Vinod Ganju","Australia","Victoria","Frankston"],["Cairns Hospital","Patrick Donald","Australia","Queensland","Cairns"],["Western Health Sunshine Hospital","Suzanne Kosmider","Australia","Victoria","St Albans"],["The Queen Elizabeth Hospital","Rachel Roberts-Thomson","Australia","South Australia","Woodville"],["Centre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hopital Sainte Musse","Clarisse Audigier-Valette","France","Var","Toulon"],["Institut Curie - Centre de Recherche","Nicolas Girard","France","Paris","Paris"],["Centre Hospitalier Universitaire d'Angers (CHU Angers)","Youssef Oulkhouir","France","Maine et Loire","Angers"],["Institut de Cancerologie de l'Ouest (ICO)- CRLCC Rene Gauducheau","Sandrine Hiret","France","Loire Atlantique","Saint Herblain Cedex"],["CHU de Rennes, Hopital de Pontchaillou","Charles Ricordel","France","Ille et Vilaine","Rennes Cedex 9"],["CHU de Caen","Simon Deshayes","France","Calvados","Caen Cedex 9"],["Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest","Sophie Cousin","France","Gironde","Bordeaux"],["Universitaetsklinikum Schleswig-Holstein (UKSH) - Campus Luebeck","Sabine Bohnet","Germany","NA","Luebeck"],["Staedtisches Klinikum Muenchen Bogenhausen","Konrad Kokowski","Germany","NA","Muenchen"],["Klinikum Kempten-Oberallgau gGmbH","Christian Schumann","Germany","NA","Kempten"],["Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)","Nikolaj Frost","Germany","NA","Berlin"],["MVZ for oncology and hematology Rhein-Kreis Neuss GmbH","Lars Galonska","Germany","NA","Neuss"],["University Medical Center of Johannes Gutenberg-University Mainz","Juergen Alt","Germany","NA","Mainz"],["Helios Klinikum Wuppertal-Universitaet Witten-Herdecke","Oliver Schmalz","Germany","NA","Wuppertal"],["Uniklinik RWTH Aachen Medizinische Klinik IV","Martin Kirschner","Germany","NA","Aachen"],["LungenClinic Grosshansdorf GmbH","Martin Reck","Germany","NA","Grosshansdorf"],["University of Wuerzburg","Pius Jung","Germany","NA","Wuerzburg"],["Evangelische Lungenklinik Berlin","Christian Grohe","Germany","NA","Berlin"],["SRH Wald-Kliniken Gera GmbH","Dagmar Taeuscher","Germany","NA","Gera"],["Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling","Folke Lohse","Germany","NA","Bonn"],["Kaiserwerther Diakonie - Florence Nightingale Krankenhaus","Stefan Krueger","Germany","NA","Dusseldorf"],["Klinikum Esslingen GmbH","Martin Faehling","Germany","NA","Esslingen"],["Klinikum Chemnitz Gmbh","Stefan Hammerschmidt","Germany","NA","Chemnitz"],["Universitaetsklinikum Heidelberg","Helge Bischoff","Germany","NA","Heidelberg"],["Casa Di Cura Polispecialistica Dott Pederzoli","Antonio Santo","Italy","NA","Peschiera del Garda"],["Azienda Ospedaliera San Gerardo di Monza","Diego Cortinovis","Italy","NA","Monza"],["Azienda Socio Sanitaria Territoriale di Cremona","Stefano Panni","Italy","NA","Cremona"],["Centro di Riferimento Oncologico","Alessandra Bearz","Italy","NA","Aviano"],["Azienda Ospedaliera San Giuseppe Moscati","Cesare Gridelli","Italy","NA","Avellino"],["Ospedale San Luca","Edi Editta Baldini","Italy","NA","Lucca"],["IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” – IRST Srl","Angelo Delmonte","Italy","NA","Meldola"],["UOC Oncoematologia AOU Luigi Vanvitelli","Floriana Morgillo","Italy","NA","Naples"],["Sendai Kousei Hospital","Shunichi Sugawara","Japan","NA","Sendai-shi"],["National Cancer Center Hospital","Yuki Shinno","Japan","NA","Tokyo"],["National Cancer Center Hospital East","Hibiki Udagawa","Japan","NA","Kashiwa"],["Osaka Prefectural Hospital Organization Osaka International Cancer Institute","Motohiro Tamiya","Japan","NA","Osaka-shi"],["National Hospital Organization Kyushu Cancer Center","Masafumi Yamaguchi","Japan","NA","Fukuoka-shi"],["Tokyo Metropolitan Komagome Hospital","Yukio Hosomi","Japan","NA","Bunkyo-Ku"],["National Hospital Organization Shikoku Cancer Center","Takashi Ninomiya","Japan","NA","Matsuyama"],["Kanagawa Cancer Center","Shuji Murakami","Japan","NA","Yokohama-shi"],["NHO Kinki Chuo Chest Medical Center","Kyoichi Okishio","Japan","NA","Sakai-city"],["National Hospital Organization Himeji Medical Center","Tetsuji Kawamura","Japan","NA","Himeji-shi"],["Kurume University Hospital","Koichi Azuma","Japan","NA","Kurume-shi"],["Okayama University Hospital","Eiki Ichihara","Japan","NA","Okayama-city"],["Korea University Guro Hospital","Sung Yong Lee","Korea, Republic of","NA","Seoul"],["Gachon University Gil Medical Center","Young Saing Kim","Korea, Republic of","NA","Incheon"],["National Cancer Center","Young Joo Lee","Korea, Republic of","NA","Goyang-si"],["Severance Hospital, Yonsei University Health System","Byoung Chul Cho","Korea, Republic of","NA","Seoul"],["Gyeongsang National University Hospital (GNUH)","Gyeong-Won Lee","Korea, Republic of","NA","Jinju-si"],["The Catholic University Of Korea, St. Vincent's Hospital","Byoung Yong Shim","Korea, Republic of","NA","Suwon-si"],["Ajou University Hospital","Hyun Woo Lee","Korea, Republic of","NA","Suwon-si"],["Asan Medical Center (AMC)","Sang-We Kim","Korea, Republic of","NA","Seoul"],["Samsung Medical Center","Se-Hoon Lee","Korea, Republic of","NA","Seoul"],["Hospital Universitario Nuestra Senora De Valme","Jose Fuentes Pradera","Spain","NA","Sevilla"],["Hospital Clinico Universitario Lozano Blesa de Zaragoza","Maria Dolores Isla Casado","Spain","NA","Zaragoza"],["Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)","Oscar Jose Juan Vidal","Spain","NA","Valencia"],["Hospital Alvaro Cunqueiro","Gerardo Huidobro Vence","Spain","NA","Vigo"],["Hospital Universitario de Badajoz","Marta Gonzalez Cordero","Spain","NA","Badajoz"],["Universidad de Sevilla - Hospital Universitario Virgen Macarena","David Vicente Baz","Spain","NA","Sevilla"],["Consorcio Hospitalario Provincial de Castellon","Alfredo Sanchez Hernandez","Spain","NA","Castellon"],["Hospital Universitario Vall d'Hebron","Pedro Da Rocha","Spain","NA","Barcelona"],["Hospital General Universitario Gregorio Maranon (HGUGM)","Antonio Calles Blanco","Spain","NA","Madrid"],["Parc de Salut Mar - Hospital del Mar","Edurne Arriola Aperribay","Spain","NA","Barcelona"],["Hospital Universitario De Leon","Soledad Medina Valdivieso","Spain","NA","Leon"],["Clinica MD Anderson International","Maria Pilar Lopez Criado","Spain","NA","Madrid"],["Ankara University Medical Faculty Hospital","Filiz Cay Senler","Turkey","NA","Mamak"],["Baskent University Adana Turgut Noyan Application and Research Center Kisla Health Campus","Ozgur Ozyilkan","Turkey","NA","Adana"],["Sakarya University - Faculty of Medicine","Ilhan Hacibekiroglu","Turkey","NA","Sakarya"],["Gazi University Faculty of Medicine","Ozan Yazici","Turkey","NA","Yenimahalle"],["Istanbul University, Istanbul Medical Faculty","Naziye Ak","Turkey","NA","Istanbul"],["Liv Hospital Ankara","Saadettin Kilickap","Turkey","NA","Ankara"],["Medical Park Seyhan Hospital","Ahmet Sezer","Turkey","NA","Adana"],["Medical Park Florya Hospital","Irfan Cicin","Turkey","NA","Istanbul"],["Gulhane Training and Research Hospital","Nuri Karadurmus","Turkey","NA","Ankara"],["Ankara Bilkent City Hospital","Mehmet Ali Nahit Sendur","Turkey","NA","Cankaya"],["Acibadem Adana Hospital","Umut Disel","Turkey","NA","Seyhan"],["Goztepe Prof. Dr. Suleyman Yalcin City Hospital","Mahmut Gumus","Turkey","NA","Kadikoy"],["Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital","Cengiz Karacin","Turkey","NA","Ankara"],["Memorial Ankara Hospital","Umut Demirci","Turkey","NA","Ankara"],["Kocaeli Universitesi Tip Fakultesi","Devrim Cabuk","Turkey","NA","Kocaeli"],["Ege University Faculty Of Medicine","Pinar Gursoy","Turkey","NA","Izmir"],["Yeditepe University Kosuyolu Hospital","Bala Basak Oven","Turkey","NA","Istanbul"],["Akdeniz University Hospital","Sema Goksu","Turkey","NA","Antalya"],["Ankara Etlik City Hospital","Goksen Imamoglu","Turkey","NA","Ankara"],["Medipol Mega Universite Hastanesi","Ahmet Bilici","Turkey","NA","Istanbul"],["Koc Universitesi Hastanesi (Koc University Hospital)","Fatih Selcukbiricik","Turkey","NA","Zeytinburnu"],["Hacettepe University Medical Faculty Oncology Hospital","Mustafa Erman","Turkey","NA","Ankara"],["Medical Point","Cagatay Arslan","Turkey","NA","Izmir"],["Nottingham University Hospitals NHS Trust - Nottingham City Hospital","Jason Adhikaree","United Kingdom","NA","Nottingham"],["Royal Devon and Exeter Hospital, Wonford - Royal Devon And Exeter NHS Foundation Trust","Petru Belitei","United Kingdom","NA","Exeter"],["Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust","Eleni Karapanagiotou","United Kingdom","NA","London"],["Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust","Philip Earwaker","United Kingdom","NA","Cambridge"],["New Cross Hospital","Talha Hafeez","United Kingdom","NA","Wolverhampton"],["Velindre NHS Trust, Velindre Cancer Centre","Paul Shaw","United Kingdom","NA","Cardiff"],["Northern Centre for Cancer Care,The Newcastle Upon Tyne Hospitals NHS Foundation Trust","Alastair Greystoke","United Kingdom","NA","Newcastle upon Tyne"],["Huddersfield Royal Infirmary - Calderdale and Huddersfield NHS Foundation Trust","Emma Rathbone","United Kingdom","NA","Huddersfield"],["Royal Stoke University Hospital - University Hospitals of North Midlands NHS Trust","Muthiah Sivaramalingam","United Kingdom","NA","Stoke-on-Trent"],["The Christie NHS Foundation Trust","Yvonne Summers","United Kingdom","NA","Manchester"],["Hull University Teaching Hospitals NHS Trust","Victoria Brown","United Kingdom","NA","Cottingham"],["Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust","Michael Davidson","United Kingdom","NA","London"],["Ninewells Hospital and Medical School - Tayside Health Board","Hannah Lord","United Kingdom","NA","Dundee"],["Torbay Hospital - South Devon Healthcare Nhs Foundation Trust","Louise Medley","United Kingdom","NA","Torquay"],["Churchill Hospital - Oxford University Hospitals NHS Foundation Trust","Nicholas Coupe","United Kingdom","NA","Oxford"],["Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust","Amin Ali","United Kingdom","NA","Preston"],["Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust","Gary Middleton","United Kingdom","NA","Birmingham"],["Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust","Michael Davidson","United Kingdom","NA","Chelsea"],["Fort Wayne Medical Oncology and Hematology, Inc","Ahad Sadiq","United States","Indiana","Fort Wayne"],["Millennium Research and Clinical Development, LLC","Anirudha Dasgupta","United States","Texas","Houston"],["Our Lady of the Lake Hospital, Inc.","Marshall Patrick Stagg","United States","Louisiana","Baton Rouge"],["University of Tennessee Medical Center","Ardy Davarifar","United States","Tennessee","Knoxville"],["Sharp Clinical Oncology Research","Priya Singh","United States","California","San Diego"],["Clermont Oncology Center","Gopal Kunta","United States","Florida","Clermont"],["Hardin Memorial Hospital","Christopher Burkeen","United States","New Jersey","Elizabethtown"],["White Plains Hospital","Dan Costin","United States","New York","White Plains"],["Frederick Health Hospital- James M Stockman Cancer Institute","Patrick Mansky","United States","Virginia","Frederick"],["Nebraska Hematology-Oncology (NHO) - Lincoln","Kailash Mosalpuria","United States","Nebraska","Lincoln"],["Hematology Oncology Associates of Fredericksburg, Inc.","Lakshminarayanan Nandagopal","United States","Virginia","Fredericksburg"],["Helen G. Nassif Community Cancer Center","Bharat Jenigiri","United States","Iowa","Cedar Rapids"],["University of Massachusetts Memorial Medical Center","William Walsh","United States","Massachusetts","North Worcester"],["McFarland Clinic","Joseph Merchant","United States","Iowa","Ames"],["Baptist Cancer Center","Osarenren Ogbeide","United States","Tennessee","Memphis"],["LSU Health Baton Rouge - North Clinic","Marshall Patrick Stagg","United States","Louisiana","Baton Rouge"],["Lahey Hospital & Medical Center","Fei Song","United States","Vermont","Burlington"],["St. Luke's Physician Group - St. Luke's Cancer Care Associates","Neil Belman","United States","Pennsylvania","Fountain Hill"],["Virginia commonwealth university school of medicine","Jonathan Berkman","United States","Virginia","Richmond"],["University of Florida Health","Devika Das","United States","Florida","Gainesville"],["The University of Texas MD Anderson Cancer Center","Carl Gay","United States","Texas","Houston"],["Cleveland Clinic","Lukas Delasos","United States","Ohio","Cleveland"],["Washington University School of Medicine","Jeffrey Ward","United States","Missouri","St. Louis"],["Kettering Medical Center","Alejandro Calvo","United States","Ohio","Kettering"],["University Hospitals Cleveland Medical Center","Afshin Dowlati","United States","Ohio","Cleveland"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["吉林省肿瘤医院药物/器械临床研究伦理审查委员会","同意","2025-02-27"],["吉林省肿瘤医院药物/器械临床研究伦理审查委员会","同意","2025-03-18"]]

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: 90 ； 国际: 439 ；
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；