登记号
CTR20252064
相关登记号
曾用名
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
试验通俗题目
BNT327与化疗和其他研究性药物联合治疗肺癌的安全性、有效性和药代动力学
试验专业题目
一项BNT327联合化疗和其他研究药物治疗一线非小细胞肺癌的全球试验的II/III期、多中心、随机主研究方案
试验方案编号
BNT327-06
方案最近版本号
V2.0
版本日期
2025-04-09
方案是否为联合用药
是
申请人信息
申请人名称
联系人姓名
百欧恩泰
联系人座机
021-52831708
联系人手机号
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
临床试验信息
试验分类
安全性和有效性
试验分期
II期
试验目的
评价BNT327联合化疗的安全性和耐受性以及有效性。
随机化
随机化
盲法
开放
试验范围
国际多中心试验
设计类型
平行分组
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。
- 根据国际抗癌联盟/美国癌症联合委员会癌症分期系统第8版，组织学或细胞学确诊IIIB或IIIC期（不适合根治性手术或放疗）或IV期NSCLC。
- 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。
- 筛选时和每次IMP给药前血清β-人绒毛膜促性腺激素试验阴性的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
- 妊娠或哺乳或计划在试验期间或IMP末次给药后6个月内妊娠或生育。
- 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。
- 有组织学或细胞学证实的NSCLC伴小细胞肺癌组织学成分。
- 在试验治疗前指定的时间间隔内接受过下列任何治疗或药物： 在筛选前30天内或试验性药物的5个半衰期内（以较短者为准）接受了试验药物或器械使用。 受试者既往接受过抗VEGF单克隆抗体或PD (L)-1/VEGF双特异性抗体治疗，或接受过铂类药物化疗和/或抗PD (L)-1作为辅助或新辅助治疗的一部分。 在开始试验治疗前14天内接受过全身皮质类固醇（剂量大于10 mg/日泼尼松或等效剂量的其他皮质类固醇）。 在开始试验治疗前4周内接种过减毒活疫苗。 在开始试验治疗前2周内接受过广谱静脉给药抗生素治疗。
- 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。
- 不允许在试验治疗前5年内有其他恶性肿瘤者。除已通过局部治疗治愈的患者外（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、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。
- 既往乙型肝炎病毒感染或乙型肝炎病毒感染已消退。
- 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。
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:PM8002注射液
|
剂型:注射剂
|
|
中文通用名:卡铂10 mg/ml输注用浓缩液
|
剂型:输注用浓缩液
|
|
中文通用名:注射用培美曲塞二钠
|
剂型:冻干粉
|
|
中文通用名:培美曲塞输注用浓缩液
|
剂型:输注用浓缩液
|
|
中文通用名:紫杉醇注射液
|
剂型:输注用溶液
|
对照药
| 名称 | 用法 |
|---|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| TEAE（包括≥3 级）、AESI、治疗相关TEAE、治疗中出现的SAE 和治疗相关SAE 的发生率。TEAE中断给药、减量和停用IMP 的事件。 | 从IMP 首次给药至90 天随访访视期间 | 安全性指标 |
| ORR | ORR 定义为观察到确认的CR或确认的PR为最佳总体缓解的受试者比例。 肿瘤大小较基线的最佳百分比变化。 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| ORR、DOR 和DCR | ORR：确认的CR或PR为BOR的受试者比例。 DOR：从首次客观缓解至首次发生客观肿瘤进展或任何原因所致死亡的时间。 DCR：为观察到确认的CR或PR或病情稳定为BOR的受试者比例。 | 有效性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 陆舜 | 医学博士 | 主任医师 | 021-22200000-3123 | shunlu_shchest@sina.com | 上海市-上海市-徐汇区淮海西路241号 | 200030 | 上海市胸科医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 上海市胸科医院 | 陆舜 | 中国 | 上海市 | 上海市 |
| 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 |
| 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 |
| 北京医院 | 李琳 | 中国 | 北京市 | 北京市 |
| 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 |
| 云南省肿瘤医院 | 杨润祥 | 中国 | 云南省 | 昆明市 |
| 汕头大学医学院附属肿瘤医院 | 林雯 | 中国 | 广东省 | 汕头市 |
| 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 |
| 上海市胸科医院 | 储天晴 | 中国 | 上海市 | 上海市 |
| 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 |
| Peninsula & South Eastern Haematology and Oncology Group | Vinod Ganju | Australia | Victoria | Frankston |
| Central West Cancer Care Centre | Andrew Jensen | Australia | NA | Orange |
| Icon Cancer Centre Kurralta Park | Anna Mislang | Australia | South Australia | Kurralta Park |
| Western Health Sunshine Hospital | Suzanne Kosmider | Australia | Victoria | St Albans |
| Cairns Hospital | Patrick Donald | Australia | Queensland | Cairns |
| ICON Cancer Care - Townsville | Abhishek Joshi | Australia | NA | Townsville |
| Cancer Research SA (CRSA) | Rohit Joshi | Australia | NA | Townsville |
| Dubbo Hospital | Andrew Jensen | Australia | NA | Dubbo |
| Royal Adelaide Hospital | Harminder Takhar | Australia | NA | Adelaide |
| Flinders Medical Centre | Christos Karapetis | Australia | NA | Bedford Park |
| Universitair Ziekenhuis Leuven | Els Wauters | Belgium | NA | Leuven |
| CHU HELORA, Hopital de Mons - Site Kennedy | Stephane Holbrechts | Belgium | NA | Mons |
| VITAZ | Charlotte van de Kerkhove | Belgium | NA | Sint-Niklaas |
| 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 |
| Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Sophie Cousin | France | Gironde | Bordeaux |
| CHU de Caen | Simon Deshayes | France | NA | Caen |
| 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 |
| Centre Francois Baclesse | Hubert Curcio | France | NA | Caen |
| Centre Hospitalier Universitaire d'Angers (CHU Angers) | Youssef Oulkhouir | France | Maine et Loire | Angers |
| Centre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.) | Christos Chouaid | France | NA | Creteil |
| Institut Paoli-Calmettes | Louis Stoffaes | France | NA | Marseille |
| LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic | Miranda Gogishvili | Georgia | NA | Tbilisi |
| New Hospitals | Davit Giorgadze | Georgia | NA | Tbilisi |
| High Technology Hospital Medcenter LTD | Tamta Makharadze | Georgia | NA | Batumi |
| LLC Todua Clinic | Tamar Melkadze | Georgia | NA | Tbilisi |
| Chemotherapy and Immunotherapy Clinic | Amiran Matitashvili | Georgia | NA | Tbilisi |
| Uniklinik RWTH Aachen Medizinische Klinik IV | Martin Kirschner | Germany | NA | Aachen |
| Evangelische Lungenklinik Berlin | Christian Grohe | Germany | NA | Berlin |
| SRH Wald-Kliniken Gera GmbH | Dagmar Taeuscher | Germany | NA | Gera |
| Klinikum Chemnitz gGmbH | Stefan Hammerschmidt | Germany | NA | Chemnitz |
| University Medical Center of Johannes Gutenberg-University Mainz | Juergen Alt | Germany | NA | Mainz |
| Staedtisches Klinikum Muenchen Bogenhausen | Konrad Kokowski | Germany | NA | Muenchen |
| University of Wuerzburg | Pius Jung | Germany | NA | Wuerzburg |
| Klinikum Esslingen GmbH | Martin Faehling | Germany | NA | Esslingen |
| MVZ for oncology and hematology Rhein-Kreis Neuss GmbH | Lars Galonska | Germany | NA | Neuss |
| Onkologische Tagesklinik Remscheid | Matthias Klee | Germany | NA | Remscheid |
| Kaiserwerther Diakonie - Florence Nightingale Krankenhaus | Mark Uhlenbruch | Germany | NA | Dusseldorf |
| Thoraxklinik-Heidelberg Ggmbh | Helge Bischoff | Germany | NA | Heidelberg |
| Universitaetsklinikum Erlangen | Marlen Haderlein | Germany | NA | Erlangen |
| Helios Klinikum Wuppertal-Universitaet Witten-Herdecke | Oliver Schmalz | Germany | NA | Wuppertal |
| Praxiskooperation Bonn-Euskirchen-Rheinbach-Wesseling | Folke Lohse | Germany | NA | Bonn |
| Asklepios Fachkliniken Muenchen Gauting | Niels Reinmuth | Germany | NA | Gauting |
| Lungenfachklinik Immenhausen - Pneumologische Lehrklinik der Universitaet Goettingen | Achim Rittmeyer | Germany | NA | Immenhausen |
| Centro di Riferimento Oncologico | Alessandra Bearz | Italy | NA | Aviano |
| Azienda Socio Sanitaria Territoriale di Cremona | Stefano Panni | Italy | NA | Cremona |
| Azienda Ospedaliera San Giuseppe Moscati | Cesare Gridelli | Italy | NA | Avellino |
| IRCCS Istituto Romagnolo per lo studio dei Tumori | Angelo Delmonte | Italy | NA | Meldola |
| ASST Papa Giovanni XXIII | Anna Bettini | Italy | NA | Bergamo |
| Fondazione Policlinico Universitario Campus Bio-Medico | Alessio Cortellini | Italy | NA | Rome |
| Ospedale San Luca | Edi Editta Baldini | Italy | NA | Lucca |
| Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte | Michele Maio | Italy | NA | Siena |
| Casa Di Cura Polispecialistica Dott Pederzoli | Antonio Santo | Italy | NA | Peschiera del Garda |
| Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola Malpighi | Francesco Gelsomino | Italy | NA | Bologna |
| Ospedale Di Cisanello,Azienda Ospedaliero Universitaria | Antonio Chella | Italy | NA | Pisa |
| UOC Oncoematologia AOU Luigi Vanvitelli | Floriana Morgillo | Italy | NA | Naples |
| Fondazione Ospedale Isola Tiberina - Gemelli Isola | Emilio Bria | Italy | NA | Rome |
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) | Alessandra Bulotta | Italy | NA | Milano |
| Istituti di Ricovero e Cura A Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE) | Federico Cappuzzo | Italy | NA | Rome |
| Tokyo Metropolitan Komagome Hospital | Yukio Hosomi | Japan | NA | Bunkyo-Ku |
| National Hospital Organization Shikoku Cancer Center | Takashi Ninomiya | Japan | NA | Matsuyama |
| Shizuoka Cancer Center | Akira Ono | Japan | NA | Suntou-gun |
| Sendai Kousei Hospital | Shunichi Sugawara | Japan | NA | Sendai City |
| The Cancer Institute Hospital of JFCR | Noriko Yanagitani | Japan | NA | Koto-Ku |
| Osaka Prefectural Hospital Organization Osaka International Cancer Institute | Motohiro Tamiya | Japan | NA | Osaka-shi |
| Kurume University Hospital | Koichi Azuma | Japan | NA | Kurume-shi |
| National Hospital Organization Himeji Medical Center | Tetsuji Kawamura | Japan | NA | Himeji-shi |
| National Cancer Center Hospital East | Yoshitaka Zenke | Japan | NA | Kashiwa |
| Wakayama Medical University Hospital | Hiroaki Akamatsu | Japan | NA | Wakayama-shi |
| NHO Kinki Chuo Chest Medical Center | Kyoichi Okishio | Japan | NA | Sakai-city |
| National Hospital Organization Iwakuni Clinical Center | Shoichi Kuyama | Japan | NA | Iwakuni-shi |
| Iwate Medical University Hospital | Hiromi Nagashima | Japan | NA | NA |
| Niigata Cancer Center Hospital | Hiroshi Tanaka | Japan | NA | Niigata-shi |
| National Hospital Organization Nagoya Medical Center | Masahide Oki | Japan | NA | Nagoya |
| Matsusaka Municipal Hospital | Osamu Hataji | Japan | NA | Matsusaka |
| Gachon University Gil Medical Center | Young Saing Kim | Republic of Korea | NA | Incheon |
| The Catholic University Of Korea, St. Vincent's Hospital | Byoung Yong Shim | Republic of Korea | NA | Suwon-si |
| Chungbuk National University Hospital | Ki Hyeong Lee | Republic of Korea | NA | Cheongju-si |
| Samsung Medical Center | Se-Hoon Lee | Republic of Korea | NA | Seoul |
| Ajou University Hospital | Hyun Woo Lee | Republic of Korea | NA | Suwon-si |
| Asan Medical Center (AMC) | Sang-We Kim | Republic of Korea | NA | Seoul |
| Korea University Guro Hospital | Sung Yong Lee | Republic of Korea | NA | Seoul |
| Chungnam National University Hospital (CNUH) | Hwan Jung Yun | Republic of Korea | NA | Daejeon |
| Severance Hospital, Yonsei University Health System | Byoung Chul Cho | Republic of Korea | NA | Seoul |
| National Cancer Center | Youngjoo Lee | Republic of Korea | NA | Goyang-si |
| Gyeongsang National University Hospital (GNUH) | Gyeong-Won Lee | Republic of Korea | NA | Jinju-si |
| Med-Polonia Sp. z o.o. | Rodryg Ramlau | Poland | NA | Poznan |
| Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii | Rafal Dziadziuszko | Poland | NA | Gdansk |
| Instytut MSF Sp. z o.o. | Ewa Kalinka | Poland | NA | Lodz |
| Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie Centrum Innowacyjnych Terapii | Izabela Chmielewska | Poland | NA | Lublin |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie | Mariusz Kwiatkowski | Poland | NA | Koszalin |
| Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu | Kamil Kuc | Poland | NA | Przemysl |
| Onco Clinic Consult SA | Patricia Visan | Romania | NA | Craiova |
| Cardiomed | Calin Cainap | Romania | NA | Cluj-Napoca |
| Radiotherapy Center Cluj | Andrei Ungureanu | Romania | NA | Cluj |
| Centrul de Oncologie Sf. Nectarie S.R.L (Sf Nectarie Oncology Center) | Michael Schenker | Romania | NA | Craiova |
| Oncomed | Daniela Sirbu | Romania | NA | Timisoara |
| S.C. Medisprof S.R.L | Adrian Udrea | Romania | NA | Cluj-Napoca |
| Coltea Clinical Hospital | Ileana Raluca Patru | Romania | NA | Bucharest |
| Ovidius Clinical Hospital | Laura Mazilu | Romania | NA | Ovidiu |
| SC Gral Medical SRL | Paula Toma | Romania | NA | Bucuresti |
| Municipal Hospital Ploiesti | Amedeia Nita | Romania | NA | Ploiesti |
| Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) | Oscar Jose Juan Vidal | Spain | NA | Valencia |
| Complejo Hospitalario Universitario Insular Materno Infantil | Delvys Rodriguez Abreu | Spain | NA | Las Palmas De Gran Canaria |
| Hospital Infanta Cristina | Marta Gonzalez Cordero | Spain | NA | Badajoz |
| Institut Catala d'Oncologia Badalona, Hospital Germans Trias I Pujol | Enric Carcereny Costa | Spain | NA | Badalona |
| 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 General Universitario Gregorio Maranon (HGUGM) | Antonio Calles Blanco | Spain | NA | Madrid |
| Hospital Universitario Fundacion Jimenez Diaz | Manuel Domine Gomez | Spain | NA | Madrid |
| Hospital Universitari de Lleida Arnau de Villanova | Alberto Rodrigo Caceres | Spain | NA | Lleida |
| Hospital Universitario de Canarias | Juana Maria Oramas Rodriguez | Spain | NA | Santa Cruz De Tenerife |
| Fundacion Instituto Valenciano de Oncologia | Sergio Sandiego Contreras | Spain | NA | Valencia |
| MD Anderson Cancer Center | Maria Pilar Lopez Criado | Spain | NA | Madrid |
| Hospital Universitario Virgen del Rocio | Maria de los Reyes Bernabe Caro | Spain | NA | Seville |
| Hospital Regional Universitario de Malaga | Vanesa Gutierrez Calderon | Spain | NA | Malaga |
| Hospital Universitario Ramon y Cajal | Maria Eugenia Olmedo Garcia | Spain | NA | Madrid |
| Hospital Alvaro Cunqueiro | Gerardo Huidobro Vence | Spain | NA | Vigo |
| Hospital Universitario De Leon | Soledad Medina Valdivieso | Spain | NA | Leon |
| Hospital Universitario Nuestra Senora De Valme | Jose Fuentes Pradera | Spain | NA | Sevilla |
| Hospital Universitario Marques De Valdecilla | Marta Lopez-Brea Piqueras | Spain | NA | Santander |
| Hospital General Universitario De Valencia | Paula Espinosa Olarte | Spain | NA | Valencia |
| Hospital Clinico Universitario Lozano Blesa de Zaragoza | Maria Dolores Isla Casado | Spain | NA | Zaragoza |
| Hospital Universitario Vall d'Hebron | Enriqueta Felip Font | Spain | NA | Barcelona |
| Hospital Universitario Puerta de Hierro de Majadahonda | Mariano Provencio Pulla | Spain | NA | Majadahonda |
| Centre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO) | Hasna Bouchaab | Switzerland | NA | Lausanne |
| Kantonspital Baden | Christine Waibel-Pachinger | Switzerland | NA | Baden |
| Vajira Hospital | Yotsawaj Runglodvatana | Thailand | NA | Bangkok |
| Lampang Cancer Hospital | Nilubol Raunroadroong | Thailand | NA | Muang |
| Chiangrai Prachanukroh Hospital | Ekkapong Tharavichitkul | Thailand | NA | Muang |
| Chulalongkorn University | Virote Sriuranpong | Thailand | NA | Bangkok |
| HRH Princess MahaChakri Sirindhorn Medical Center - Srinakharinwirot University | Chanchai Charonpongsuntorn | Thailand | NA | Nakhon Nayok |
| Rajavithi Hospital | Piyawan Tienchaiananda | Thailand | NA | Ratchathewi |
| Liv Hospital Ankara | Saadettin Kilickap | Turkey | NA | Ankara |
| Istinye University Bahcesehir Liv Hospital | Erkan Kayikcioglu | Turkey | NA | Istanbul |
| Medical Park Seyhan Hospital | Ahmet Sezer | Turkey | NA | Seyhan/Adana |
| Medical Park Florya Hospital | Irfan Cicin | Turkey | NA | Kucukcekmece |
| Gulhane Training and Research Hospital | Nuri Karadurmus | Turkey | NA | Ankara |
| Acibadem Adana Hospital | Umut Disel | Turkey | NA | Seyhan |
| Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital | Cengiz Karacin | Turkey | NA | Ankara |
| Memorial Ankara Hospital | Umut Demirci | Turkey | NA | Ankara |
| Yeditepe University Kosuyolu Hospital | Bala Basak Oven | Turkey | NA | Istanbul |
| Medipol Mega Universite Hastanesi | Ahmet Bilici | Turkey | NA | Istanbul |
| Hacettepe University Medicine Faculty | Mustafa Erman | Turkey | NA | Ankara |
| Medical Point Izmir Hospital | Cagatay Arslan | Turkey | NA | Izmir |
| Ankara Bilkent City Hospital | Mehmet Ali Nahit Sendur | Turkey | NA | Ankara |
| Bezmialem Foundation University Medical Faculty | Mesut Seker | Turkey | NA | Istanbul |
| Gaziantep Sanko University Medical Faculty | Mustafa Yildirim | Turkey | NA | Gaziantep |
| Kocaeli Universitesi Tip Fakultesi | Devrim Cabuk | Turkey | NA | Kocaeli |
| Ege University Faculty Of Medicine | Pinar Gursoy | Turkey | NA | Izmir |
| Istanbul University, Istanbul Medical Faculty | Naziye Ak | Turkey | NA | Istanbul |
| Akdeniz University Hospital | Sema Goksu | Turkey | NA | Antalya |
| Goztepe Prof. Dr. Suleyman Yalcin City Hospital | Mahmut Gumus | Turkey | NA | Kadikoy |
| Sakarya University - Faculty of Medicine | Ilhan Hacibekiroglu | Turkey | NA | Sakarya |
| Koc Universitesi Hastanesi (Koc University Hospital) | Fatih Selcukbiricik | Turkey | NA | NA |
| Gazi University Faculty of Medicine | Ozan Yazici | Turkey | NA | Yenimahalle |
| Adana City Training and Research Hospinal | Timucin Cil | Turkey | NA | Adana |
| Ondokuz Mayis University Health Practice and Research Hospital | Bahiddin Yilmaz | Turkey | NA | Samsun |
| Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust | James Spicer | United Kingdom | NA | London |
| University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary | Sean Dulloo | United Kingdom | NA | Leicester |
| Velindre NHS Trust, Velindre Cancer Centre | Paul Shaw | United Kingdom | NA | Cardiff |
| Royal Preston Hospital - Lancashire Teaching Hospitals NHS Foundation Trust | TaiChung Lam | United Kingdom | NA | Preston |
| The James Cook University Hospital (JCUH) - South Tees Hospitals NHS Foundation Trust (South Cleveland Hospital) | Talal Mansy | United Kingdom | NA | Middlesbrough |
| Beatson West of Scotland Cancer Centre - Greater Glasgow Health Board | Nicola Steele | United Kingdom | NA | Glasgow |
| Royal Sussex County Hospital - University Hospitals Sussex NHS Foundation Trust | Kamarul Zaki | United Kingdom | NA | Brighton |
| Sarah Cannon Research Institute | Anja Williams | United Kingdom | NA | London |
| St James's University Hospital - Leeds Teaching Hospitals NHS Trust | Kevin Franks | United Kingdom | NA | Leeds |
| The Christie NHS Foundation Trust | Yvonne Summers | United Kingdom | NA | Manchester |
| New Cross Hospital | Talha Hafeez | United Kingdom | NA | Wolverhampton |
| Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust | Michael Davidson | United Kingdom | NA | London |
| Hull University Teaching Hospitals NHS Trust | Victoria Brown | United Kingdom | NA | Cottingham |
| Southampton General Hospital | Judith Cave | United Kingdom | NA | Southampton |
| Churchill Hospital - Oxford University Hospitals NHS Foundation Trust | Nicholas Coupe | United Kingdom | NA | Oxford |
| Clatterbridge Cancer Centre | Carles Escriu Justo | United Kingdom | NA | Liverpool |
| Royal Marsden Hospital (RMH) - Royal Marsden NHS Foundation Trust | Michael Davidson | United Kingdom | NA | Chelsea |
| Weston Park Hospital - Sheffield Teaching Hospitals NHS Foundation Trust | Robin Young | United Kingdom | NA | Sheffield |
| University College London Hospitals - University College London Hospitals NHS Foundation Trust | Siow Ming Lee | United Kingdom | NA | London |
| Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust | Mabel Teng | United Kingdom | NA | Birmingham |
| John Theurer Cancer Center, Hackensack University Medical Center | Martin Gutierrez | United States | NA | Hackensack |
| Clermont Oncology Center | Gopal Kunta | United States | Florida | Clermont |
| Moffitt Cancer Center | Andreas Saltos | United States | NA | Tampa |
| The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion | Eli Kirshner | United States | NA | Paramus |
| Valkyrie Clinical Trials | David Berz | United States | NA | Los Angeles |
| Montefiore Medical Center | Balazs Halmos | United States | NA | East Syracuse |
| Sharp Clinical Oncology Research | Priya Singh | United States | California | San Diego |
| Summit Medical Group Oregon | William Schmidt | United States | NA | Bend |
| Alaska Oncology and Hematology, LLC | Steven Liu | United States | NA | Anchorage |
| SSM Health Cancer Care - St. Clare | Mansoor Haq | United States | NA | Fenton |
| Fletcher Hospital, Inc. dba AdventHealth Hendersonville | Jennifer Heaberlin | United States | NA | Hendersonville |
| Vermont Regional Cancer Center | Farrah Khan | United States | Vermont | Burlington |
| Millennium Research and Clinical Development, LLC | Anirudha Dasgupta | United States | Texas | Houston |
| Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center | Christine Lovly | United States | NA | Nashville |
| University of Tennessee Medical Center | Ardy Davarifar | United States | Tennessee | Knoxville |
| John Muir Clinical Research Center | Gigi Chen | United States | NA | Concord |
| Baptist Health Hardin | Christopher Burkeen | United States | New Jersey | Elizabethtown |
| Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics | Muhammad Furqan | United States | NA | Iowa City |
| White Plains Hospital | Dan Costin | United States | NA | White Plains |
| Regional Cancer Care Associates, LLC (RCCA) | Iuliana Shapira | United States | NA | Little Silver |
| University of Missouri Health Care - Ellis Fischel Cancer Center (EFCC) | Vipul Bhanderi | United States | NA | Columbia |
| Rutgers, The State University of New Jersey - Robert Wood Johnson Medical School - The Cancer Institute of New Jersey (CINJ) | Siu-Long Yao | United States | NA | East Brunswick |
| University Of California - San Diego Moores Cancer Center | Lyudmila Bazhenova | United States | NA | La Jolla |
| University of Cincinnati Medical Center | Jennifer Leddon | United States | NA | Cincinnati |
| Physicians Clinic of Iowa | Bharat Jenigiri | United States | Iowa | Cedar Rapids |
| Cleveland Clinic | Michael Menefee | United States | Ohio | Cleveland |
| Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) | Mehmet Copur | United States | NA | Hastings |
| Baptist Cancer Center | William Walsh | United States | Tennessee | Memphis |
| Kettering Medical Center | Alejandro Calvo | United States | Ohio | Kettering |
| VCU Massey Cancer Center | Renato Martins | United States | NA | Richmond |
| The Christ Hospital Cancer Center | Alexander Starodub | United States | NA | Cincinnati |
| INTEGRIS Cancer Institute of Oklahoma | Bashar Alasad | United States | NA | Oklahoma City |
| Suny-Stony Brook University Cancer Center | Amna Sher | United States | NA | Stony Brook |
| Frederick Health Hospital- James M Stockman Cancer Institute | Patrick Mansky | United States | Virginia | Frederick |
| The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion | Michael Menefee | United States | NA | Cleveland |
| Cleveland Clinic - Hillcrest Hospital | Michael Menefee | United States | NA | Mayfield Heights |
| 上海市胸科医院 | 陈智伟 | 中国 | 上海市 | 上海市 |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 上海市胸科医院伦理委员会 | 同意 | 2025-04-21 |
试验状态信息
试验状态
进行中-招募完成
目标入组人数
国内: 6 ；
国际: 40 ；
已入组例数
国内: 3 ；
国际: 登记人暂未填写该信息；
实际入组总例数
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：2025-07-02；
国际：登记人暂未填写该信息；
第一例受试者入组日期
国内：2025-08-05；
国际：登记人暂未填写该信息；
试验终止日期
国内：登记人暂未填写该信息；
国际：登记人暂未填写该信息；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
