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A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer (METalmark)

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研究单位: [1]Janssen Research & Development,LLC [2]University of Alabama at Birmingham,Comprehensive Cancer Center Birmingham,Alabama,United States,35233 [3]UCLA Los Angeles,California,United States,90095 [4]University of California,Irvine Orange,California,United States,92868 [5]The Oncology Institute of Hope and Innovation Whittier,California,United States,90603 [6]University of Chicago Chicago,Illinois,United States,60637-1426 [7]Montefiore Einstein Center for Cancer Care Bronx,New York,United States,10467 [8]University of North Carolina Chapel Hill,North Carolina,United States,27599-1651 [9]Providence Portland Medical Center Portland,Oregon,United States,97213 [10]Virginia Cancer Specialists Fairfax,Virginia,United States,22031 [11]VCU Medical Center Richmond,Virginia,United States,23219 [12]Medical College Of Wisconsin Milwaukee,Wisconsin,United States,53226 [13]PERSONAL - Oncologia de Precisão e Personalizada Belo Horizonte,Brazil,30130-090 [14]CIONC - Centro Integrado de Oncologia de Curitiba Curitiba,Brazil,80810-050 [15]UPCO Unidade de Pesquisa Clinica em Oncologia Pelotas,Brazil,96020 080 [16]União Brasileira de Educação e Assistência-Hospital São Lucas da PUCRS Porto Alegre,Brazil,90610-000 [17]Oncoclínicas Rio de Janeiro S.A. Rio de Janeiro,Brazil,22250-905 [18]Instituto D'Or de Pesquisa e Ensino (IDOR) Rio de Janeiro,Brazil,22281-100 [19]Núcleo de Oncologia da Bahia Salvador,Brazil,40170-110 [20]Fundação Antônio Prudente - A.C. Camargo Cancer Center Sao Paulo,Brazil,01509900 [21]Sociedade Beneficente de Senhoras - Hospital Sírio Libanês São Paulo,Brazil,01308-901 [22]The Ottawa Hospital Research Institute Ottawa,Ontario,Canada,K1Y 4E9 [23]University Health Network (UHN) Princess Margaret Cancer Centre Toronto,Ontario,Canada,M5G 1Z5 [24]Beijing Cancer Hospital Beijing,China,100142 [25]Sichuan Cancer Hospital Chengdu,China,610041 [26]West China Hospital,Sichuan University Chengdu,China,610041 [27]Chongqing University Cancer Hospital Chongqing,China,400030 [28]The First Affiliated Hospital,Sun Yat-sen University Guangzhou,China,510060 [29]The First Affiliated Hospital,Zhejiang University College of Medicine Hangzhou,China,310003 [30]Second Affiliated Hospital,School of Medicine,Zhejiang University Hangzhou,China,310009 [31]Sir Run Run Shaw Hospital,Zhejiang University School of Medicine Hangzhou,China,310016 [32]Harbin medical university cancer hospital Harbin,China,150081 [33]Huizhou Municipal Central Hospital Huizhou,China,516001 [34]Fudan University Shanghai Cancer Center Shanghai,China,200032 [35]Shanghai Pulmonary Hospital Shanghai,China,200433 [36]Shengjing Hospital of China Medical University Shenyang,China,110055 [37]The First Affiliated Hospital of Xi'an Jiaotong University Xi'An,China,710061 [38]Yantai Yuhuangding Hospital Yantai,China,264000 [39]Henan Cancer Hospital Zhengzhou,China,450008 [40]Institute Coeur Poumon Lille,France,59000 [41]Centre Leon Bérard Lyon Cedex 8,France,69008 [42]CHU de la Timone Marseille,France,13005 [43]Institut Curie PARIS Cedex 5,France,75248 [44]Institut de cancerologie de l'ouest Saint-Herblain Cedex,France,44805 [45]Nouvel Hopital Civil - CHU Strasbourg Strasbourg cedex,France,67091 [46]Charite Universitaetsmedizin Berlin Berlin,Germany,12203 [47]Helios Klinikum Emil von Behring GmbH Berlin,Germany,14165 [48]Klinikum Chemnitz gGmbH Chemnitz,Germany,09116 [49]Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden,Germany,01307 [50]Universitaetsklinikum Essen Essen,Germany,45147 [51]Universitaetsklinikum Koeln Koeln,Germany,50937 [52]Universitaetsklinikum Muenster Muenster,Germany,48149 [53]Munchen Klinik GmbH Klinik Bogenhausen München,Germany,81925 [54]Fondazione IRCCS Istituto Nazionale dei Tumori Milano,Italy,20133 [55]ASST Grande Ospedale Metropolitano Niguarda Milano,Italy,20162 [56]Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS Napoli,Italy,80131 [57]Istituto Oncologico Veneto - IRCCS Padova,Italy,35128 [58]Ospedale S. Maria Delle Croci Ravenna,Italy,48121 [59]Istituto Nazionale Tumori Regina Elena Rome,Italy,00128 [60]National Hospital Organization Nagoya Medical Center Nagoya-shi,Japan,460-0001 [61]Shizuoka Cancer Center Sunto-gun,Japan,411-8777 [62]The Cancer Institute Hospital of JFCR Tokyo,Japan,135-8550 [63]Chungbuk National University Hospital Cheongju-si,Korea,Republic of,28644 [64]National Cancer Center Goyang-Si,Korea,Republic of,10408 [65]Gachon University Gil Hospital Incheon,Korea,Republic of,21565 [66]Chonnam National University Hwasun Hospital Jeollanam-do,Korea,Republic of,58128 [67]Seoul National University Bundang Hospital Seongnam,Korea,Republic of,13620 [68]Seoul National University Hospital Seoul,Korea,Republic of,03080 [69]Severance Hospital,Yonsei University Health System Seoul,Korea,Republic of,03722 [70]Asan Medical Center Seoul,Korea,Republic of,05505 [71]Uniwersyteckie Centrum Kliniczne Gdansk,Poland,80-214 [72]INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp. z o.o. Lublin,Poland,20-609 [73]Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warszawa,Poland,02-781 [74]Hosp. Univ. A Coruña A Coruña,Spain,15006 [75]Hosp. Gral. Univ. de Alicante Alicante,Spain,03010 [76]Hosp. Del Mar Barcelona,Spain,08003 [77]Hosp. Univ. Quiron Dexeus Barcelona,Spain,08028 [78]Hosp. Univ. Vall D Hebron Barcelona,Spain,08035 [79]Hosp. Clinic I Provincial de Barcelona Barcelona,Spain,08036 [80]Hosp. Univ. Fund. Jimenez Diaz Madrid,Spain,28040 [81]Hosp. Univ. 12 de Octubre Madrid,Spain,28041 [82]Hosp. Univ. La Paz Madrid,Spain,28046 [83]Hosp. Virgen Macarena Sevilla,Spain,41009 [84]Hosp. Clinico Univ. de Valencia Valencia,Spain,46010 [85]Memorial Ankara Hastanesi Ankara,Turkey,06520 [86]Gazi University Hospital Ankara,Turkey,06560 [87]Ankara Bilkent City Hospital Ankara,Turkey,06590 [88]Liv Hospital Ankara Ankara,Turkey,06680 [89]Istanbul University Cerrahpasa Medical Faculty Istanbul,Turkey,34098 [90]Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Istanbul,Turkey,34722 [91]UCL Cancer Institute London,United Kingdom,NW1 2PG [92]Imperial College London and Imperial College Healthcare NHS Trust London,United Kingdom,W2 1NY [93]Freeman Hospital Newcastle,United Kingdom,NE7 7DN [94]Royal Marsden Hospital Sutton,United Kingdom,SM2 5PT

研究目的:
The purpose of this study is to identify the recommended Phase 2 combination dose (RP2CD[s]) of the amivantamab and capmatinib combination therapy in participants with non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection), and to evaluate the antitumor effect of the amivantamab and capmatinib combination therapy in mesenchymal-epithelial transition (MET) exon 14 skipping mutation and MET amplified NSCLC, when administered at the selected RP2CD(s) in Phase 2 (expansion).

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