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A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

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研究单位: [1]AbbVie [2]Cancer and Blood Speciality Clinic - Los Alamitos /ID# 251671,Los Alamitos,California,United States,90720-3309 [3]Valley Medical Center /ID# 251880,Renton,Washington,United States,98055-5738 [4]Monash Medical Centre /ID# 247679,Clayton,Victoria,Australia,3168 [5]Beijing Cancer Hospital /ID# 247881,Beijing,Beijing,China,100142 [6]Chongqing University Three Gorges Hospital /ID# 247772,Wanzhou,Chongqing,China,404199 [7]The First Affiliated Hospital of Guangzhou Medical University /ID# 247828,Guangzhou,Guangdong,China,510163 [8]Harbin Medical University Cancer Hospital /ID# 248982,Harbin,Heilongjiang,China,150081 [9]Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 247882,Wuhan,Hubei,China,430022 [10]Tongji Hospital Tongji Medical College of HUST /ID# 249018,Wuhan,Hubei,China,430030 [11]Renmin Hospital of Wuhan University /ID# 249019,Wuhan,Hubei,China,430060 [12]Shandong Cancer Hospital /ID# 247823,Jinan,Shandong,China,251601 [13]Sichuan Cancer Hospital /ID# 247909,Chengdu,Sichuan,China,610041 [14]West China Hospital, Sichuan University /ID# 247783,Chengdu,Sichuan,China,610041 [15]The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 249068,Hangzhou,Zhejiang,China,310006 [16]Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 247840,Hangzhou,Zhejiang,China,310020 [17]Zhejiang Cancer hospital /ID# 248958,Hangzhou,Zhejiang,China,310022 [18]Shanghai Chest Hospital /ID# 247826,Shanghai,China,200030 [19]Zhongshan Hospital Fudan University /ID# 247771,Shanghai,China,200032 [20]CHU Lille - Hôpital Albert Calmette /ID# 246263,Lille,Hauts-de-France,France,59037 [21]HCL - Hôpital Louis Pradel /ID# 246267,Bron,France,69500 [22]Centre Jean Perrin /ID# 246268,Clermont Ferrand,France,63011 [23]Universitaetsklinikum Giessen /ID# 250462,Gießen,Hessen,Germany,35392 [24]Asklepios Fachkliniken Muenchen-Gauting /ID# 248082,Gauting,Germany,82131 [25]Pius-Hospital Oldenburg /ID# 249107,Oldenburg,Germany,26121 [26]The Chaim Sheba Medical Center /ID# 243207,Ramat Gan,Tel-Aviv,Israel,5265601 [27]Hadassah Medical Center-Hebrew University /ID# 243298,Jerusalem,Yerushalayim,Israel,91120 [28]Rambam Health Care Campus /ID# 246781,Haifa,Israel,3109601 [29]Meir Medical Center /ID# 243208,Kfar Saba,Israel,4428164 [30]Rabin Medical Center /ID# 248631,Petakh Tikva,Israel,4941492 [31]Ospedale San Raffaele IRCCS /ID# 247588,Milan,Milano,Italy,20132 [32]ASST Monza/Ospedale San Gerardo /ID# 247584,Monza,Monza E Brianza,Italy,20900 [33]Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 248329,Candiolo,Torino,Italy,10060 [34]Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 249156,Ancona,Italy,60126 [35]IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 247585,Rome,Italy,00144 [36]National Cancer Center Hospital East /ID# 250317,Kashiwa-shi,Chiba,Japan,277-8577 [37]National Hospital Organization Kyushu Cancer Center /ID# 250714,Fukuoka-shi,Fukuoka,Japan,811-1395 [38]Hokkaido University Hospital /ID# 250316,Sapporo-shi,Hokkaido,Japan,060-8648 [39]Osaka International Cancer Institute /ID# 251507,Osaka-shi,Osaka,Japan,541-8567 [40]Shizuoka Cancer Center /ID# 251752,Sunto-gun,Shizuoka,Japan,411-8777 [41]National Cancer Center Hospital /ID# 250319,Chuo-ku,Tokyo,Japan,104-0045 [42]Pusan National University Yangsan Hospital /ID# 248489,Yangsan-si,Gyeongsangnamdo,Korea, Republic of,50612 [43]Chungbuk National Univ Hosp /ID# 248405,Cheongju,Korea, Republic of,28644 [44]Keimyung University Dongsan Medical Center /ID# 247371,Daegu,Korea, Republic of,41931 [45]Samsung Medical Center /ID# 248407,Seoul,Korea, Republic of,06351 [46]Spitalul Municipal Ploiesti /ID# 248609,Ploiesti,Prahova,Romania,100337 [47]Spitalul Clinic Coltea /ID# 248608,Bucharest,Romania,030171 [48]Institutul Oncologic Prof Dr I Chiricuta /ID# 248610,Cluj Napoca,Romania,400015

关键词: c-Met NSCLC Telisotuzumab Vedotin ABBV-399 Cancer Non Small Cell Lung Cancer NSCLC MET Amplified NSCLC

研究目的:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine how telisotuzumab vedotin affects the disease state in adult participants with previously untreated participants with MET amplified non-squamous NSCLC. Change in disease activity will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of MET amplified non-squamous NSCLC. Participants receive intravenously (IV) infused of telisotuzumab vedotin. Approximately 70 adult participants with previously untreated MET amplified locally advanced/metastatic non-squamous NSCLC will be enrolled in the study in approximately 110 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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