上海MRTX849片II期临床试验-MRTX849单药或联合pembrolizumab 治疗KRAS G12C突变的非小细胞肺癌II期研究

登记号	CTR20250645	试验状态	进行中
申请人联系人	李阳	首次公示信息日期	2025-02-25
申请人名称	Mirati Therapeutics, Inc./ 再鼎医药（上海）有限公司/ Patheon Inc.

登记号	CTR20250645
相关登记号	暂无
药物名称	MRTX849片
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	非小细胞肺癌
试验专业题目	评价MRTX849单药或联合帕博利珠单抗治疗携带KRAS G12C突变的晚期非小细胞肺癌的II期研究
试验通俗题目	MRTX849单药或联合pembrolizumab 治疗KRAS G12C突变的非小细胞肺癌II期研究
试验方案编号	849-007	方案最新版本号	8.0
版本日期:	2023-11-09	方案是否为联合用药	否

申请人名称	[["Mirati Therapeutics, Inc."],["再鼎医药（上海）有限公司"],["Patheon Inc."]]
联系人姓名	李阳	联系人座机	021-61633161	联系人手机号	13604303308
联系人Email	yang.li@zailaboratory.com	联系人邮政地址	上海市-上海市-上海市浦东张江高科技园区金科路4560号金创大厦1号楼4楼	联系人邮编	201203

评价MRTX849单药以及联合帕博利珠单抗一线治疗KRAS G12C突变NSCLC患者的临床有效性 。 表征单药以及联合治疗方案在特定人群中的安全性和耐受性。 评价在特定人群中使用单药和联合治疗方案的次要有效性终点。 评价MRTX849单药以及联合帕博利珠单抗给药的药代动力学（PK）。

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

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	[["经组织学确诊为携带KRAS G12C突变的NSCLC（鳞状或非鳞状）且PD-L1肿瘤比例评分（TPS）已知，根据RECIST 1.1版，存在可测量病灶。"],["不可切除或转移性疾病。"],["非根治性治疗候选者（例如，局部晚期疾病的放化疗）"],["预期可提供具有代表性的肿瘤样本（原发或转移病灶的、存档或新采集的），用于中心实验室检测合并基因改变（如果之前未提供所需数量的样本（见实验室手册））。"],["年龄≥18岁。对于法定知情年龄大于18岁的国家，受试者必须符合所在国家的法定年龄要求。"],["预期寿命至少3个月。"],["既往局部区域治疗所致的不良反应已恢复至基线或1级（不包括脱发）。"],["ECOG体能状况评分为0或1。"],["筛选期实验室检查值应满足以下标准：n 中性粒细胞绝对计数≥1,000/ mm3（≥1.0×109/L）n 血小板计数≥100,000/mm3（≥100×109/L）n 在至少2周内未输血的情况下，血红蛋白≥9 g/dLn 总胆红素≤1.5×ULN（如果伴有肝转移或Gilbert病，则≤3×ULN）n 天门冬氨酸氨基转移酶（AST）和ALT均≤3.0×ULN（如果伴有肝转移，则≤5×ULN）n 肌酐清除率≥50 mL/min。"],["有生育能力的女性（WOCBP）或伴侣为WOCBP的男性同意在参与本研究期间以及研究治疗终止后6个月或当地产品说明书要求的更长时间内使用避孕措施。"],["完成知情同意过程，包括签署机构审查委员会（IRB）/伦理委员会（EC）批准的知情同意书（ICF）。"],["愿意遵守临床试验说明和要求。"]]
排除标准	[["既往接受过局部晚期或转移性NSCLC全身治疗，包括化疗、免疫CIT或靶向KRAS G12C突变的治疗（例如sotorasib）"],["有活动性脑转移。若存在脑转移且脑转移得到了充分治疗，并且患者在首次研究给药前神经系统稳定了至少2周，则患者具有入选资格。如患者需要使用皮质类固醇治疗，则必须在首次研究治疗给药前接受稳定或递减剂量的泼尼松（或等效剂量）≤10 mg每天一次。"],["首次研究给药前6个月内接受肺部放疗>30 Gy。"],["癌性脑膜炎。"],["活动性或既往记录的自身免疫性或炎症性疾病"],["免疫功能低下"],["首次研究给药前30天内接种过活疫苗"],["已知对研究药物和/或其任何辅料重度过敏"],["已知人类免疫缺陷病毒（HIV）感染或者急慢性乙型肝炎（HBV）或丙型肝炎（HCV）感染。"],["首次研究给药前4周内进行过大手术。"],["存在有可能改变研究治疗吸收或无法吞服药物的肠道疾病史或胃部大手术史。"],["以下任何一种心脏异常：n 过去6个月内发生不稳定型心绞痛或心肌梗死。n 过去6个月内出现症状性或未控制的房颤。n 在过去6个月内，充血性心力衰竭≥NYHA 3级。n 校正的QC间期（QTc）延长>480毫秒或有先天性长QT综合征家族史或病史。"],["首次研究给药前6个月内有卒中或短暂性脑缺血发作史。"],["需要持续接受已知会导致QTc间期延长的合并用药治疗，且在入组研究前无法转换为其他替代药物。"],["已知或怀疑存在其他恶性肿瘤，在疾病评估时可能会被误认为是正在研究的恶性肿瘤。"],["妊娠。在研究药物开始给药前的筛选期内，WOCBP的血清或尿妊娠试验结果必须为阴性。"],["在研究期间或末次研究给药后6个月内进行或计划进行母乳喂养。"],["存在任何研究者认为可能会干扰患者参与研究或影响结果解读的严重疾病、未控制的并发疾病、精神疾病、活动性或未控制的感染或其他病史，包括实验室检测异常。"]]

试验药	[["中文通用名:MRTX849片 英文通用名:MRTX849Tablets 商品名称:NA","剂型:片剂 规格:200mg/片 用法用量:队列1a:400mg每天两次（BID）,连续口服给药;队列1b:600mg每天两次（BID）,连续口服给药;队列2：400mg每天两次（BID）,连续口服给药; 用药时程:达到停止治疗标准"]] 序号 名称 用法
对照药	[["中文通用名:帕博利珠单抗注射液 英文通用名:Pembrolizumabinjection 商品名称:可瑞达","剂型:注射剂 规格:100mg/4ml 用法用量:200m,Q3W 用药时程:达到停止治疗标准"]] 序号 名称 用法

主要终点指标及评价时间	[["客观缓解率（ORR）","第1年每6周，第2年及以后每12周","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	[["缓解持续时间（DOR）","第1年每6周，第2年及以后每12周","有效性指标"],["无进展生存期（PFS）","第1年每6周，第2年及以后每12周","有效性指标"],["总生存期（OS）","从治疗结束访视至死亡或失访，每2个月","有效性指标"],["1年生存率","首次随机用药开始12个月","有效性指标"],["不良事件","随机用药第一天开始报告，持续至治疗结束访视","安全性指标"],["血浆中MRTX849和潜在代谢物浓度","给药后4-6小时","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	陆舜	学位	医学博士	职称	主任医师
	电话	021-22200000	Email	shunlu_shchest@sina.com	邮政地址	上海市-上海市-上海市淮海西路241号
	邮编	200030	单位名称	上海市胸科医院

[["上海市胸科医院","陆舜","中国","上海市","上海市"],["浙江省肿瘤医院","范云","中国","浙江省","杭州市"],["北京肿瘤医院","赵军","中国","北京市","北京市"],["四川大学华西医院","王永生","中国","四川省","成都市"],["四川省肿瘤医院","姚文秀","中国","四川省","成都市"],["陆军军医大学第一附属医院","周向东","中国","重庆市","重庆市"],["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"],["湖南省肿瘤医院","邬麟","中国","湖南省","长沙市"],["南昌大学第一附属医院","张伟","中国","江西省","南昌市"],["吉林大学白求恩第一医院","崔久嵬","中国","吉林省","长春市"],["福建省肿瘤医院","庄武","中国","福建省","福州市"],["南方医科大学南方医院","刘来昱","中国","广东省","广州市"],["广州医科大学附属第一医院","周承志","中国","广东省","广州市"],["复旦大学附属中山医院","胡洁","中国","上海市","上海市"],["复旦大学附属肿瘤医院","王佳蕾","中国","上海市","上海市"],["浙江大学医学院附属第一医院","周建英","中国","浙江省","杭州市"],["南京市第一医院","谷伟","中国","江苏省","南京市"],["北京协和医院","张力","中国","北京市","北京市"],["山东省肿瘤医院","郭其森","中国","山东省","济南市"],["河南省肿瘤医院","王慧娟","中国","河南省","郑州市"],["辽宁省肿瘤医院","马锐","中国","辽宁省","沈阳市"],["西安交大大学第一附属医院","姚煜","中国","陕西省","西安市"],["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"],["Inha University Hospital","Jun Hyeok Lim","韩国","Gyeonggi-do","Incheon"],["Multiscan - Ambulance klinické onkologie se stacioná?em - Ho?ovice","Martin Smakal","捷克共和国","NA","NA"],["Tüd?gyógyintézet rkbálint","éva Morócz","匈牙利","NA","NA"],["Mátrai Gyógyintézet","László Urbán","匈牙利","Heves","NA"],["Istituto Romagnolo per lo Studio dei Tumori","Angelo Delmonte","意大利","Forlì-Cesena","Meldola"],["Istituto Nazionale Tumori IRCCS Fondazione G. Pascale","Alessandro Morabito","意大利","Naples","Napoli"],["Azienda Ospedaliero-Universitaria di Parma","Marcello Tiseo","意大利","Parma","Parma"],["Istituto Europeo di Oncologia","Filippo De Marinis","意大利","Milan","Milano"],["Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Emilio Bria","意大利","Roma","Roma"],["Het Nederlands Kanker Instituut","Egbert Smit","荷兰","Noord-Holland","Amsterdam"],["Ziekenhuis St Jansdal Harderwijk","S.J.M. (Steven) Gans","荷兰","Provincie Gelderland","Harderwijk"],["Erasmus Medisch Centrum","Anne-Marie Dingemans","荷兰","Zuid-Holland","Rotterdam"],["British Columbia Cancer Agency - Vancouver","Janessa Laskin","加拿大","NA","vancouver"],["Princess Margaret Cancer Centre","Penelope Bradbury","加拿大","NA","Toronto"],["Virginia Cancer Institute - West End","Thomas Weart","美国","NA","Virginia"],["University of California San Francisco Helen Diller Family Comprehensive Cancer Center","Collin Blakely","美国","California","San Francisco"],["GenesisCare USA","Edgardo Santos","美国","NA","NA"],["USOR - Arizona Oncology Associates - Prescott Valley","Allan Espinosa Morazan","美国","Arizona","Prescott Valley"],["Cancer Specialists of North Florida - Southpoint","Gaurav Trikha","美国","North Florida","NA"],["Cancer Specialists Of North Florida - St. Augustine","Gaurav Trikha","美国","North Florida","NA"],["Cancer Specialists of North Florida - Fleming Island","Gaurav Trikha","美国","North Florida","NA"],["Cancer Specialists of North Florida - Baptist South","Gaurav Trikha","美国","North Florida","NA"],["Cancer Specialists of North Florida - Riverside","Gaurav Trikha","美国","North Florida","NA"],["Cancer Specialists of North Florida - Southside","Gaurav Trikha","美国","North Florida","NA"],["Cancer Specialists Of North Florida - Beaches","Gaurav Trikha","美国","North Florida","NA"],["Cancer Specialists of North Florida - Northside","Gaurav Trikha","美国","North Florida","NA"],["Advocate Medical Group Oncology","Jason Macklis","美国","Chicago","Park Ridge"],["Arizona Clinical Research Center","Manuel Modiano","美国","Arizona","Tucson"],["Arizona Blood & Cancer Specialists - Tucson Paradise Falls #105","Manuel Modiano","美国","Arizona","Tucson"],["Arizona Blood & Cancer Specialists - Tucson Paradise Fall #119","Manuel Modiano","美国","Arizona","Tucson"],["Arizona Blood & Cancer Specialists - Esperanza Boulevard","Manuel Modiano","美国","Arizona","Tucson"],["Arizona Blood & Cancer Specialists - Oro Valley","Manuel Modiano","美国","Arizona","Tucson"],["Arizona Blood & Cancer Specialists - Safford","Manuel Modiano","美国","Arizona","Tucson"],["Stockton Hematology Oncology Medical Group (SHOMG)","Chunhui Fang","美国","California","Stockton"],["Jackson Oncology Associates - The Hederman Cancer Center","Natale Sheehan","美国","Mississippi","Jackson"],["USOR - Minnesota Oncology - Burnsville","Sandeep Jain","美国","Minnesota","Burnsville"],["USOR - Minnesota Oncology - Edina Clinic","Sandeep Jain","美国","Minnesota","Edina"],["Nebraska Cancer Specialists - Midwest Cancer Center - Legacy","Mary Huerter Wells","美国","Nebraska","Fremont"],["Nebraska Cancer Specialists - Methodist Estabrook Cancer Center","Mary Huerter Wells","美国","Nebraska","Omaha"],["Nebraska Cancer Specialists - Henry Lynch Cancer Center","Mary Huerter Wells","美国","Nebraska","Omaha"],["Nebraska Cancer Specialists - Midwest Cancer Center - Papillion","Mary Huerter Wells","美国","Nebraska","Papillion"],["Nebraska Cancer Specialists - Regional Cancer Center - St Francis","Mary Huerter Wells","美国","Nebraska","Fremont"],["Bay Pines Veterans Affairs Healthcare System","Ryan Burri","美国","Florida","Bay Pines"],["Hospital Clínic de Barcelona","Nuria Vi？olas","西班牙","Barcelona","Barcelona"],["Hospital Clínico San Carlos","Carlos Aguado","西班牙","Madrid","Madrid"],["Hospital Universitari i Politècnic La Fe","Oscar Juan Vidal","西班牙","NA","NA"],["Hospital Universitario Ramón y Cajal","Maria Pilar Garrido Lopez","西班牙","NA","NA"],["Hospital Regional Universitario de Málaga - Hospital Civil","Vanesa Gutiérrez Calderón","西班牙","Málaga","Málaga"],["Hospital Universitario Fundación Jiménez Díaz","Manuel Dómine Gomez","西班牙","Madrid","Madrid"],["Hospital Universitari Vall d'Hebrón","Enriqueta Felip","西班牙","Barcelona","Barcelona"],["Complejo Hospitalario Universitario A Corua","Maria Rosario Garcia Campelo","西班牙","La Corua","La Corua"],["Hospital Universitari Dexeus","Andres Aguilar Hernandez","西班牙","Barcelona","Barcelona"],["Hospital Universitario 12 de Octubre","Luis Paz-Ares Rodríguez","西班牙","Madrid","Madrid"],["Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)","Ernesto Nadal Alforja","西班牙","NA","NA"],["Hospital de la Santa Creu i Sant Pau","Margarita Majem Tarruella","西班牙","Barcelona","Barcelona"],["Hospital Universitario Virgen del Rocío","Maria De Los Reyes Bernabe Caro","西班牙","Sevilla","Sevilla"],["Universitair Medisch Centrum Utrecht","Anne Van Lindert","荷兰","Utrecht","Utrecht"],["Országos Onkológiai Intézet","Tünde Nagy","匈牙利","NA","NA"],["Pratia Pozna","Marcin Grabicki","波兰","Wielkopolskie","Skórzewo"],["MS Pnuemed - Janusz Milanowski, Katarzyna Szmygin-Milanowska Spó?ka Jawna","Izabela Chmielewska","波兰","Lubelskie","Lublin"],["Hospital Clínico Universitario de Santiago","Jorge Garcia Gonzalez","西班牙","La Corua","Santiago de Compostela"],["Dana-Farber Cancer Institute","Pasi Janne","美国","Massachusetts","Boston"],["USOR - Virginia Cancer Specialists - Fairfax Office","Alexander Spira","美国","Virginia","Fairfax"],["USOR - Virginia Cancer Specialists - Alexandria Office","Alexander Spira","美国","Virginia","Alexandria"],["USOR - Virginia Cancer Specialists - Gainesville Office","Alexander Spira","美国","Virginia","Gainesville"],["USOR - Virginia Cancer Specialists - Loudoun Office","Alexander Spira","美国","Virginia","Leesburg"],["USOR - Virginia Cancer Specialists - Arlington Office","Alexander Spira","美国","Virginia","Arlington"],["Kettering Cancer Center - Kettering Health Network","Alejandro Calvo","美国","Ohio","Kettering"],["University Hospitals Cleveland Medical Center","Debora Bruno","美国","Ohio","Cleveland"],["21st Century Oncology of Jacksonville - North Lee Street","Troy Guthrie Jr.","美国","Florida","Jacksonville"],["John Theurer Cancer Center","Martin Gutierrez","美国","New Jersey","Hackensack"],["Providence Medical Group - Santa Rosa","Manasa Vulchi","美国","California","Santa Rosa"],["New York Oncology Hematology - Albany Medical Center","Makenzi Evangelist","美国","NewYork","Albany"],["Texas Oncology Dallas Fort Worth West (DFFW) - Bedford","Henrik Illum","美国","Texas","Bedford"],["USOR - Rocky Mountain Cancer Centers - Lone Tree","Robert Jotte","美国","Colorado","Lone Tree"],["USOR - Rocky Mountain Cancer Centers - Lakewood","Robert Jotte","美国","Colorado","Lakewood"],["USOR - Rocky Mountain Cancer Centers - Pueblo","Robert Jotte","美国","Colorado","Pueblo"],["USOR - Rocky Mountain Cancer Centers - Colorado Springs","Robert Jotte","美国","Colorado","Colorado Springs"],["USOR - Rocky Mountain Cancer Centers - Boulder","Robert Jotte","美国","Colorado","Boulder"],["USOR - Rocky Mountain Cancer Centers - Denver - Midtown","Robert Jotte","美国","Colorado","Denver"],["USOR - Rocky Mountain Cancer Centers - Thornton","Robert Jotte","美国","Colorado","Thornton"],["USOR - Rocky Mountain Cancer Centers - Longmont","Robert Jotte","美国","Colorado","Longmont"],["USOR - Rocky Mountain Cancer Centers - Aurora","Robert Jotte","美国","Colorado","Aurora"],["USOR - Rocky Mountain Cancer Centers - Denver - Rose Medical Center Campus","Robert Jotte","美国","Colorado","Denver"],["USOR - Rocky Mountain Cancer Centers - Littleton","Robert Jotte","美国","Colorado","Littleton"],["Texas Oncology Northeast Texas - Tyler","Donald Richards","美国","Texas","Tyler"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海市胸科医院伦理委员会","同意","2022-05-11"],["上海市胸科医院伦理委员会","同意","2024-09-25"]]

序号	名称	审查结论	批准日期/备案日期

进行中（招募完成）

目标入组人数	国内: 33 ； 国际: 220 ；
已入组人数	国内: 30 ； 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：2022-08-03；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：2022-08-15；     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；