一、题目和背景信息
| 登记号 |
CTR20243544 |
| 相关登记号 |
暂无
|
| 药物名称 |
NA |
| 药物类型 |
化学药物
|
|
临床申请受理号
|
企业选择不公示 |
| 适应症 |
选定的HER2突变或过表达/扩增实体瘤 |
| 试验专业题目 |
Beamion PANTUMOR-1：一项评价口服zongertinib（BI 1810631）治疗选定的HER2突变或过表达/扩增实体瘤的疗效和安全性的II期、多中心、多队列、开放标签试验 |
| 试验通俗题目 |
Beamion PANTUMOR-1：一项检验zongertinib是否有助于治疗携带HER2变异的晚期癌症患者的研究 |
| 试验方案编号 |
1479-0009 |
方案最新版本号
|
1.0版 |
| 版本日期: |
2024-03-27 |
方案是否为联合用药 |
否 |
二、申请人信息
| 申请人名称 |
[["Boehringer Ingelheim International GmbH"],["勃林格殷格翰(中国)投资有限公司"],["Hovione FarmaCiencia SA；Seran BioScience,LLC"],["Almac Clinical Services, LLC；Almac Clinical Services, LLC；Boehringer Ingelheim Pharma GmbH & Co. KG"]] |
| 联系人姓名 |
勃林格殷格翰临床试验信息公示组 |
联系人座机 |
021-52883966 |
联系人手机号 |
|
| 联系人Email |
MEDCTIDgroup.CN@boehringer-ingelheim.com |
联系人邮政地址 |
上海市-上海市-上海市静安区南京西路1601号越洋广场29楼 |
联系人邮编 |
200040 |
三、临床试验信息
1、试验目的
主要目的：本试验的主要目的是在各种实体瘤中评估zongertinib单药治疗的抗肿瘤活性。
次要目的：是评价zongertinib的疗效、安全性、耐受性和风险-获益特征，并评价患者报告结局（PRO）。
2、试验设计
| 试验分类 |
安全性和有效性 |
试验分期 |
II期
|
设计类型 |
单臂试验
|
| 随机化 |
非随机化
|
盲法 |
开放
|
试验范围 |
国际多中心试验
|
3、受试者信息
| 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 |
[["入组本试验前，签署符合ICH-GCP和当地法规的书面知情同意书并注明日期。"],["患者签署ICF时的年龄≥18岁，或超过法定同意年龄（对于法定同意年龄大于18岁的国家/地区）。"],["记录的（既往通过当地检测确定）HER2状态为：na. HER2过表达/扩增nb. 已知的HER2激活突变"],["患者入组研究后必须提交存档（入组）肿瘤组织样本，用于回顾性确认HER2状态（入组组织样本）。如果没有可用的存档组织，特殊情况下经申办方书面同意后可以接受。请注意，样本不得取自活检前进行过放射治疗辐照的区域。"],["患者常规治疗失败或不存在有确切疗效的治疗或不适合采用既有治疗手段。患者必须已用尽或不适合使用已知可延长其疾病生存期的现有治疗手段。"]]
|
| 排除标准 |
[["诊断为HER2突变NSCLC"],["除了本试验治疗的恶性肿瘤外，过去3年内曾患有其他恶性肿瘤或合并患有其他恶性肿瘤，但以下情况除外：na. 经过有效治疗的非黑色素瘤皮肤癌nb. 经过有效治疗的宫颈原位癌nc. 经过有效治疗的导管原位癌nd. 经过局部有效治疗已治愈的其他恶性肿瘤"],["患者必须或希望继续使用禁用药物或者任何可能干扰本临床试验安全实施的药物"],["筛选前进行的大手术（研究者评估为大手术）未完全恢复，或计划在筛选后6个月内进行大手术，如髋关节置换术"]]
|
4、试验分组
| 试验药 |
| 序号 |
名称 |
用法 |
[["中文通用名:NA
英文通用名:Zongertinib
商品名称:NA","剂型:片剂
规格:无
用法用量:口服吞服，单剂量组，固定剂量，最多1次剂量降低
用药时程:直至患者发生疾病进展或直至符合其他停药标准"]]
|
| 对照药 |
|
5、终点指标
| 主要终点指标及评价时间 |
| 序号 |
指标 |
评价时间 |
终点指标选择 |
[["客观缓解定义为通过中心独立审查评估的最佳总体疗效为经确认的完全缓解或经确认的部分缓解，并从治疗开始日期开始评估，直至疾病进展、死亡或开始后续抗癌治疗/试验治疗终止前末次可评价肿瘤评估（以最早发生为准）","最长37个月","有效性指标"]]
|
| 次要终点指标及评价时间 |
| 序号 |
指标 |
评价时间 |
终点指标选择 |
[["通过中心独立审查评估的客观缓解持续时间（DOR），DOR定义为确认客观缓解的患者从首次记录到经确认的OR（根据RECIST 1.1）直至疾病进展或死亡（以最早发生者为准）的时间。","最长37个月","有效性指标"],["通过中心独立审查评估的无进展生存期（PFS），PFS定义为从治疗开始直至最早出现肿瘤进展（根据RECIST 1.1）或因任何原因死亡（以最早发生者为准）的时间。","最长37个月","有效性指标"],["通过中心独立审查评估的疾病控制，DC定义为最佳总体疗效为CR或PR或疾病稳定，并从首次治疗给药开始评估，直至疾病进展、死亡或开始后续抗癌治疗/试验治疗终止前末次可评价肿瘤评估（以最早发生者为准）。","最长37个月","有效性指标"],["治疗期间出现的AE发生率。","最长37个月","安全性指标"],["欧洲癌症研究与治疗组织评定项列表（EORTC IL19）（5项，EORTC生活质量问卷[QLQ-C30]的生理功能量表）从基线至第48周或PD时（以先发生者为准）的变化。","基线，最多48周","有效性指标+安全性指标"]]
|
四、研究者信息
1、主要研究者信息
| 1 |
姓名 |
李进 |
学位 |
医学博士 |
职称 |
主任医师 |
| 电话 |
021-38804518 |
Email |
lijin@csco.org.cn |
邮政地址 |
上海市-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 |
2、各参加机构信息
| 序号 |
机构名称 |
主要研究者 |
国家 |
省（州） |
城市 |
[["上海市东方医院","李进","中国","上海市","上海市"],["上海市东方医院","郭晔","中国","上海市","上海市"],["南昌大学第一附属医院","李勇","中国","江西省","南昌市"],["河南省肿瘤医院","杨树军","中国","河南省","郑州市"],["Macquarie University","Park, John","澳大利亚","New South Wales","Macquarie Park"],["Princess Alexandra Hospital","O'Byrne, Kenneth","澳大利亚","Queensland","Woolloongabba"],["St John of God Subiaco Hospital","Clay, Timothy","澳大利亚","Western Australia","Subiaco"],["GenesisCare North Shore","Pavlakis, Nick","澳大利亚","New South Wales","St Leonards"],["Edegem - UNIV UZ Antwerpen","Prenen, Hans","比利时","NA","Edegem"],["Brussels - UNIV Saint-Luc","Van Marcke de Lummen, Cedric","比利时","NA","Bruxelles"],["McGill University Health Centre (MUHC)","Saleh, Ramy","加拿大","Quebec","Montreal"],["Princess Margaret Cancer Centre","Bedard, Philippe","加拿大","Ontario","Toronto"],["Centre Hospitalier de l'Universite de Montreal (CHUM)","Samouelian, Vanessa","加拿大","Quebec","Montreal"],["INS Gustave Roussy","Planchard, David","法国","NA","Villejuif"],["INS Bergonie","Italiano, Antoine","法国","NA","Bordeaux"],["HOP la Miletrie","Emambux, Sheik","法国","NA","Poitiers"],["CTR Georges-Francois Leclerc","Ghiringhelli, Francois","法国","NA","Dijon"],["Universitatsklinikum Mannheim GmbH","Marme, Frederik","德国","NA","Mannheim"],["Universitat Leipzig","Lordick, Florian","德国","NA","Leipzig"],["Justus-Liebig Universitat GieBen","Wehler, Thomas","德国","NA","GieBen"],["Asklepios Kliniken GmbH & Co. KGaA","Arnold, Dirk","德国","NA","Hamburg"],["Klinikum rechts der Isar der Technischen Universitat Munchen","Lorenzen, Sylvie","德国","NA","Munchen"],["Az. Ospedaliere Umberto I di Ancona","Berardi, Rossana","意大利","Marche","ANCONA"],["ASST Grande Ospedale Metropolitano Niguarda","Siena, Salvatore","意大利","Lombardia","Milano"],["AOU Universit degli Studi della Campania Luigi Vanvitelli","Martinelli, Erika","意大利","Campania","Napoli"],["Istituto Scientifico Romagnolo","Bittoni, Alessandro","意大利","Emilia-Romagna","Meldola (FC)"],["Osaka International Cancer Institute","Sugimoto, Naotoshi","日本","NA","Osaka, Osaka"],["Shizuoka Cancer Center","Ko, Ryo","日本","NANA","Shizuoka, Sunto-gun"],["National Cancer Center Hospital East","Matsubara, Nobuaki","日本","NA","Chiba, Kashiwa"],["Aichi Cancer Center Hospital","Kojima, Takahiro","日本","NA","Aichi, Nagoya"],["Japanese Foundation for Cancer Research","Kitano, Shigehisa","日本","NA","Tokyo, Koto-ku"],["National Cancer Center Hospital","Maruki, Yuta","日本","NA","Tokyo, Chuo-ku"],["Samsung Medical Center","Park, Joon Oh","大韩民国","NA","Seoul"],["Asan Medical Center","Ryu, Min-Hee","大韩民国","NA","Seoul"],["Seoul National University Hospital","Youk, Jeonghwan","大韩民国","NA","Seoul"],["Severance Hospital","Jung, Min-Kyu","大韩民国","NA","Seoul"],["Nederlands Kanker Instituut","Opdam, Frans","荷兰","NA","AMSTERDAM"],["Radboud Universitair Medisch Centrum","Desar, I.M.E.","荷兰","NA","NIJMEGEN"],["Oslo Universitetssykehus HF, Radiumhospitalet","Guren, Tormod","挪威","NA","OSLO"],["Hospital Vall d'Hebron","Hernando Calvo, Alberto","西班牙","Barcelona","Barcelona"],["Hospital Clinico San Carlos","Bartolome, Jorge","西班牙","Madrid","Madrid"],["Hospital A Coruna","Fernandez Bruno, Manuel","西班牙","La Coruna","A Coruna"],["Hospital Virgen del Rocio","Gil Torralvo, Ana","西班牙","Sevilla","Sevilla"],["Clinica Universidad de Navarra","Ponz, Mariano","西班牙","Navarra","Pamplona"],["Clinica Universidad de Navarra - Madrid","Ponz, Mariano","西班牙","Madrid","Madrid"],["Hospital del Mar","Martinez Garcia, Maria","西班牙","Barcelona","Barcelona"],["Icahn School of Medicine at Mount Sinai","Doroshow, Deborah","美国","New York","New York"],["University of California Los Angeles","Salani, Ritu","美国","California","Los Angeles"],["Pan American Center for Oncology Trials, LLC","Garcia Pallas, Maria","美国","Puerto Rico","Rio Piedras"],["Precision NextGen Oncology","Sankhala, Kamlesh","美国","California","Beverly Hills"],["Mary Crowley Cancer Research Center","Barve, Minal","美国","Texas","Dallas"],["Memorial Sloan-Kettering Cancer Center","Li, Bob","美国","New York","New York"],["Alaska Oncology","Liu, Steven","美国","Alaska","Anchorage"],["University of Arizona Comprehensive Cancer Center","Segar, Jennifer","美国","Arizona","Phoenix"],["Scripps Cancer Center Torrey Pines","Sarvaria, Aditya","美国","California","La Jolla"],["The University of Texas MD Anderson Cancer Center","Dumbrava, Ecaterina","美国","Texas","Houston"],["Yale University School of Medicine","LoRusso, Patricia","美国","Connecticut","New Haven"],["Maryland Oncology Hematology, PA","Wallmark, John","美国","Maryland","Rockville"],["Illinois Cancer Specialists","Siegel, Richard","美国","Illinois","Arlington Heights"],["Alliance Cancer Specialists, PC","Potz, Joseph","美国","Pennsylvania","Horsham"],["BRCR Global","Schneider, Andrew","美国","Florida","Plantation"],["Karmanos Cancer Institute","Mamdani, Hirva","美国","Michigan","Detroit"]]
五、伦理委员会信息
| 序号 |
名称 |
审查结论 |
批准日期/备案日期 |
[["上海市东方医院药物/器械临床试验伦理委员会","同意","2024-06-26"],["上海市东方医院药物/器械临床试验伦理委员会","同意","2024-07-11"]]
六、试验状态信息
1、试验状态
进行中（尚未招募）
2、试验人数
| 目标入组人数 |
国内: 10 ；
国际: 200 ； |
| 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； |
3、受试者招募及试验完成日期
| 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； |
