一、题目和背景信息
| 登记号 |
CTR20243284 |
| 相关登记号 |
暂无
|
| 药物名称 |
MEDI5752 |
| 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 |
实体瘤 |
| 试验专业题目 |
一项在实体瘤研究参与者中评价Volrustomig预激方案与其他抗癌药物联合治疗的安全性、耐受性、药代动力学、免疫原性和抗肿瘤活性的开放性II期研究（eVOLVE-01） |
| 试验通俗题目 |
Volrustomig预激方案的探索性II期平台研究 |
| 试验方案编号 |
D798KC00001 |
方案最新版本号
|
1.0 |
| 版本日期: |
2024-01-24 |
方案是否为联合用药 |
否 |
二、申请人信息
| 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."]] |
| 联系人姓名 |
曹静 |
联系人座机 |
010-58797672 |
联系人手机号 |
13166205203 |
| 联系人Email |
Fiona.Cao@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1505室 |
联系人邮编 |
100200 |
三、临床试验信息
1、试验目的
本研究目的是在特定实体瘤研究参与者中评估volrustomig与其他抗癌药物联合治疗的安全性、耐受性、药代动力学、免疫原性和抗肿瘤活性。
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 |
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
|
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 |
[["美国东部肿瘤协作组（ECOG）体能状态评分为0或1，且未出现恶化。"],["预期生存时间≥12周。"],["器官和骨髓功能正常。"],["筛选期和随机化时体重>35 kg。"],["经组织学或细胞学确诊为NSQ NSCLC。"],["无EGFR敏感突变。"],["作为当地标准实践的一部分进行的检测显示，无明确记录的任何其他的具有当地批准可用的一线靶向治疗的可操作驱动癌基因改变。"],["基线时至少存在一个既往未接受过放疗的可准确测量其长径≥10 mm的可测量病灶。"]]
|
| 排除标准 |
[["脊髓压迫。"],["有原发性活动性免疫缺陷病史。"],["活动性或既往记录的自身免疫性或炎性疾病。"],["组织学为小细胞肺癌和NSCLC混合型或肉瘤样癌。"],["脑转移，除非无症状、稳定、在开始研究干预治疗前至少14天不需要类固醇治疗。放疗结束到研究入组必须至少间隔2周。"],["既往接受过IV期NSCLC化疗或任何其他全身治疗。既往接受含铂辅助治疗、新辅助治疗或根治性放化疗治疗的研究参与者如果在最后一次治疗结束后>12个月发生进展（包括曾参加过一线全身治疗临床试验），有资格入组。"]]
|
4、试验分组
| 试验药 |
| 序号 |
名称 |
用法 |
[["中文通用名:MEDI5752
英文通用名:MEDI5752
商品名称:NA","剂型:注射剂
规格:NA
用法用量:Volrustomig(MEDI5752)给药方案1或Volrustomig(MEDI5752)给药方案2。研究参与者将通过静脉输注接受Volrustomig(MEDI5752)。
用药时程:NA"]]
|
| 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 |
[["出现不良事件 (AE) 和严重不良事件 (SAE) 的参与者人数","从筛查（第-28 天至第-1天）至 2.4 年","安全性指标"],["客观缓解率（ORR）","长达2.4 年","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 |
[["疾病控制率（DCR）","长达2.4 年","有效性指标"],["缓解持续时间(DoR)","长达2.4 年","有效性指标"],["无进展生存期(PFS)","长达2.4 年","有效性指标"],["总生存期(OS)","长达2.4 年","有效性指标"],["Volrustomi的血清浓度","长达2.4 年","有效性指标"],["谷浓度","长达2.4 年","有效性指标"],["药物的峰值浓度（Cmax）","长达2.4 年","有效性指标"],["药时曲线下面积（AUC）","长达2.4 年","有效性指标"],["抗药抗体 (ADA) 呈阳性的参与者人数","长达2.4 年","有效性指标"]]
|
四、研究者信息
1、主要研究者信息
| 1 |
姓名 |
王孟昭 |
学位 |
医学博士 |
职称 |
主任医师 |
| 电话 |
13911235467 |
Email |
mengzhaowang@sina.com |
邮政地址 |
北京市-北京市-东城区王府井帅府园1号 |
| 邮编 |
100730 |
单位名称 |
中国医学科学院北京协和医院 |
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 |
[["中国医学科学院北京协和医院","王孟昭","中国","北京市","北京市"],["济南市中心医院","孙美丽","中国","山东省","济南市"],["烟台毓璜顶医院","孙萍","中国","山东省","烟台市"],["浙江省人民医院","卢丽琴","中国","浙江省","杭州市"],["郑州大学第一附属医院","黄思远","中国","河南省","郑州市"],["Centre Hospitalier Intercommunal De Creteil","Chouaid Christos","法国","Paris","Creteil"],["Centre de Cancerologie du Grand Montpellier","Becht Catherine","法国","Herault","Montpellier"],["Centre de Lutte Contre le Cancer (CLCC) - Centre Georges Francois Leclerc (CGFL)","Ghiringhelli Francois","法国","Cote-d'Or","Dijon Cedex"],["Chu Hopitaux De Rouen","Guisier Florian","法国","Seine-Maritime","Rouen Cedex"],["Centre Francois Baclesse - Pneumologie","Curcio Hubert","法国","Calvados","Caen Cedex 05"],["High Technology Hospital MedCenter LTD","Makharadze Tamta","格鲁吉亚","Ajaria","Batumi"],["LTD Israeli-Georgian Medical Research Clinic Helsicore","Arkania Ekaterine","格鲁吉亚","Tbilisi","Tbilisi"],["Tbilisi St Med U Ingorokva High Med","Gogishvili Miranda","格鲁吉亚","Tbilisi","Tbilisi"],["LTD NEW HOSPITALS","Giorgadze Davit","格鲁吉亚","Tbilisi","Tbilisi"],["ICO-Institute of Clinical Oncology - Hospital","Vladimer Kuchava","格鲁吉亚","Tbilisi","Tbilisi"],["Severance Hospital, Yonsei University Health System","Kim Hye Ryun","韩国","Seoul Teugbyeolsi","Seoul"],["The Catholic University of Korea, St. Vincent's Hospital","Shim Byoung Yong","韩国","Gyeonggido","Suwon-Si"],["Seoul National University Bundang Hospital","Kim Yu Jung","韩国","Gyeonggido","Seongnam-Si"],["The Catholic University of Korea, Seoul St. Mary's Hospital","Kang Jin Hyoung","韩国","Seoul Teugbyeolsi","Seoul"],["Valkyrie Clinical Trials","Berz David","美国","California","Los Angeles"],["Henry Ford Hospital","Gadgeel Shirish","美国","Michigan","Detroit"],["St. Mary's Hospital and Regional Medical Center - St. Mary's","Work Kyle","美国","Colorado","Grand Junction"],["Saint Joseph Hospital","Log Karng","美国","Colorado","Wheat Ridge"],["University of North Carolina (UNC) Health Care - UNC Hospitals - Adult Oncology Clinics - Chapel Hill - Oncology","Weiss Jared","美国","North Carolina","Chapel Hill"],["Signal Point Clinical Research Center, LLC","Nandagopal Vrindavanam","美国","Washington","Tacoma"],["Unidade Local De Saude De Santo Antonio E.P.E.","Araujo Antonio","葡萄牙","Porto","Porto"],["Hospital CUF Porto","Parente Barbara","葡萄牙","Porto","Porto"],["Unidade Local de Saude de Santa Maria, E. P. E.","Marques da Costa Luis","葡萄牙","Lisboa","Lisboa"],["H. Santo Antonio Capuchos-Centro Hospitalar e Universitario","Guerreiro Ines","葡萄牙","Lisboa","Lisboa"],["Hopitaux Universitaires de Geneve","Addeo Alfredo","瑞士","Geneve","Geneve"],["University Hospital Zurich - Oncology","Richter Ulrich","瑞士","Zurich","Zurich"],["Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)","Hasna Bouchaab","瑞士","Vaud (fr)","Lausanne"],["Kantonsspital Winterthur","Laetitia Mauti","瑞士","Zurich","Winterthur"],["Hospital Arnau De Vilanova De Valencia","Garde Noguera Javier","西班牙","Valencia","Valencia"],["Hospital Quironsalud Malaga","Cobo Dols Manuel","西班牙","Malaga","Malaga"],["Complexo Hospitalario Universitario De Santiago","Garcia Gonzalez Jorge Jose","西班牙","A Coruna","Santiago De Compostela"],["Hospital Universitario Y Politecnico La Fe","Juan Vidal Oscar","西班牙","Valenciana, Comunidad","Valencia"],["Hospital de La Santa Creu i Sant Pau","Majem Tarruella Margarita","西班牙","Barcelona","Barcelona"],["Complexo Hospitalario Universitario A Coruna","Fernandez Bruno Manuel","西班牙","Galicia","A Coruna"],["Hospital de Navarra","Morilla Ruiz Idoia","西班牙","Navarra","Pamplona"],["Hospital Universitario Fundacion Alcorcon","Jimenez Aguilar Elisabeth","西班牙","Madrid","Alcorcon"],["Hospital Universitario Marques de Valdecilla","Lopez-Brea Piqueres Marta","西班牙","Cantabria","Santander"],["Hospital Universitario 12 de Octubre","Paz-Ares Rodriguez Luis","西班牙","Madrid","Madrid"],["ASUIUD, PO S. Maria della Misericordia","Cortiula Francesco","意大利","Udine","Udine"],["Borgo Roma, Policlinico G. Rossi, AOU Integrata Verona","Milella Michele","意大利","Verona","Verona"],["Azienda Ospedaliero-Universitaria San Luigi Gonzaga","Novello Silvia","意大利","Piemonte","Orbassano"],["Istituto Clinico Humanitas Rozzano, IRCCS","Toschi Luca","意大利","Milano","Rozzano"],["Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori IRCCS","Delmonte Angelo","意大利","Emilia-Romagna","Meldola"],["Ospedale S.Maria della Misericordia, AO di Perugia, Universita degli Studi di Perugia","Metro Giulio","意大利","Perugia","Perugia"],["Ospedale Policlinico San Martino, IRCCS","Genova Carlo","意大利","Genova","Genova"],["Istituto Nazionale dei Tumori, Fondazione IRCCS","Proto Claudia","意大利","Milano","Milano"],["Taipei Medical University - Taipei Medical University Hospital","蕭世欣","中国台湾","台北","台北"],["Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare","李岡遠","中国台湾","台北","新北市"],["Changhua Christian Medical Foundation Changhua Christian Hospital","林聖皓","中国台湾","彰化","彰化"],["National Taiwan University Hospital - Cancer Center","楊志新","中国台湾","台北","台北"]]
五、伦理委员会信息
| 序号 |
名称 |
审查结论 |
批准日期/备案日期 |
[["中国医学科学院北京协和医院药物临床试验伦理委员会","修改后同意","2024-05-22"],["中国医学科学院北京协和医院药物临床试验伦理委员会","同意","2024-06-03"]]
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: 13 ；
国际: 120 ； |
| 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； |
