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A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

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研究单位: [1]Janssen Research & Development, LLC [2]Southern Cancer Center, PC,Mobile,Alabama,United States,36607 [3]Arizona Oncology Associates,Tucson,Arizona,United States,85711 [4]City of Hope,Duarte,California,United States,91010 [5]Cedars-Sinai Medical Center,Los Angeles,California,United States,90048 [6]University of California, Irvine,Orange,California,United States,92868 [7]Rocky Mountain Cancer Centers,Colorado Springs,Colorado,United States,80907 [8]Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center,Fort Lauderdale,Florida,United States,33308 [9]University Cancer & Blood Center, LLC,Athens,Georgia,United States,30607 [10]University of Mississippi Medical Center,Jackson,Mississippi,United States,39216 [11]Nebraska Cancer Specialists,Grand Island,Nebraska,United States,68803 [12]Astera Cancer Care,East Brunswick,New Jersey,United States,08816 [13]TriHealth Network,Cincinnati,Ohio,United States,45220 [14]Providence Portland Medical Center,Portland,Oregon,United States,97213 [15]Kaiser Permanente Northwest,Portland,Oregon,United States,97227 [16]Alliance Cancer Specialists,Horsham,Pennsylvania,United States,19044 [17]University of Pittsburgh Medical Center,Pittsburgh,Pennsylvania,United States,15232 [18]Baptist Cancer Center,Memphis,Tennessee,United States,38120 [19]Texas Oncology-Medical City Dallas,Dallas,Texas,United States,75230 [20]Texas Oncology-Baylor Charles A. Sammons Cancer Center,Dallas,Texas,United States,75246 [21]Oncology Consultants - Texas,Houston,Texas,United States,77030 [22]Texas Oncology - Northeast,Longview,Texas,United States,75601 [23]University of Vermont Medical Center,Burlington,Vermont,United States,05401 [24]University of Virginia,Charlottesville,Virginia,United States,22908 [25]Virginia Cancer Specialists,Fairfax,Virginia,United States,22031 [26]Blue Ridge Cancer Care,Wytheville,Virginia,United States,24382 [27]NorthWest Medical Specialties, PLLC,Puyallup,Washington,United States,98373 [28]IADT Instituto Argentino de Diagnostico y Tratamiento,Caba,Argentina,C1122 [29]Centro Medico Fleischer,Caba,Argentina,C1414 [30]CEMIC (Centro de Educación Médica e Investigaciones Clínicas),Caba,Argentina,C1431FWO [31]CINME - Centro de Investigaciones Metabolicas,Ciudad Autonoma de Buenos Aires,Argentina,C1027AAP [32]Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica,Córdoba,Argentina,5000 [33]Hospital Privado Universitario de Córdoba,Córdoba,Argentina,X5016KEH [34]Hospital Privado de la Comunidad,Mar del Plata,Argentina,B7602CBM [35]Clínica Viedma,Viedma,Argentina,R8500ACE [36]Grand Hôpital de Charleroi, site Notre Dame,Charleroi,Belgium,6000 [37]UZA,Edegem,Belgium,2650 [38]UZ Gent,Gent,Belgium,9000 [39]Jessa Ziekenhuis - Campus Virga Jesse,Hasselt,Belgium,3500 [40]UZ Leuven,Leuven,Belgium,3000 [41]CHU Sart-Tilman,Liege,Belgium,4000 [42]Clinique Saint Pierre,Ottignies,Belgium,1340 [43]Cetus Oncologia,Belo Horizonte,Brazil,30110-017 [44]CIONC - Centro Integrado de Oncologia de Curitiba,Curitiba,Brazil,80810-050 [45]Ynova Pesquisa Clinica,Florianopolis,Brazil,88020-210 [46]Fundação São Francisco Xavier,Ipatinga,Brazil,35162 189 [47]UPCO Unidade de Pesquisa Clinica em Oncologia,Pelotas,Brazil,96020 080 [48]Associação Hospitalar Moinhos de Vento,Porto Alegre,Brazil,90035-001 [49]Hospital Ernesto Dornelles,Porto Alegre,Brazil,90160-093 [50]Oncoclínicas Rio de Janeiro S.A.,Rio de Janeiro,Brazil,22250-905 [51]Instituto D'Or de Pesquisa e Ensino (IDOR),Rio de Janeiro,Brazil,22281-100 [52]Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI),Rio de Janeiro,Brazil,22775-001 [53]Núcleo de Oncologia da Bahia,Salvador,Brazil,40170-110 [54]Hospital Sao Rafael,Salvador,Brazil,41253-190 [55]CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia,Santo André,Brazil,09060-650 [56]Fundação Antônio Prudente - A.C. Camargo Cancer Center,Sao Paulo,Brazil,01509900 [57]IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado,Sorocaba,Brazil,18030-005 [58]Hospital Paulistano,São Paulo,Brazil,01323-000 [59]Real e Benemérita Associação Portuguesa de Beneficência,São Paulo,Brazil,01323-900 [60]Hospital Alemão Oswaldo Cruz,São Paulo,Brazil,01327-001 [61]Hospital Nove de Julho,São Paulo,Brazil,01409902 [62]Onco Star SP Oncologia Ltda,São Paulo,Brazil,04543-000 [63]COT - Centro Oncológico do Triangulo S.A,Uberlândia,Brazil,38408-150 [64]Multifunctional Hospital for Active Treatment ''Serdika'',Sofia,Bulgaria,1303 [65]Multiprofile Hospital for Active Treatment ''Tokuda Hospital Sofia'',Sofia,Bulgaria,1407 [66]Specialized Hospital for Active Treatment in Oncology,Sofia,Bulgaria,1756 [67]UMHAT Sofia Med,Sofia,Bulgaria,1797 [68]Tom Baker Cancer Centre,Calgary,Alberta,Canada,T2N 4N2 [69]British Columbia Cancer Agency,Vancouver,British Columbia,Canada,V5Z 4E6 [70]McGill University Health Centre,Montreal,Quebec,Canada,H4A 3J1 [71]Cancer Hospital, Chinese Academy of Medical Sciences,Beijing,China,100021 [72]Peking University People''s Hospital,Beijing,China,100044 [73]Beijing Cancer Hospital,Beijing,China,100142 [74]Chinese PLA General Hospital,Beijing,China,100853 [75]Beijing Chest hospital, Capital medical university,Beijing,China,101199 [76]Hunan Cancer hospital,Changsha,China,410013 [77]Sichuan Cancer Hospital,Chengdu,China,610041 [78]West China Hospital, Sichuan University,Chengdu,China,610041 [79]Chongqing University Cancer Hospital,Chongqing,China,400000 [80]Southwest Hospital,ChongQing,China,400038 [81]The First Affiliated Hospital, Sun Yat-sen University,Guang Zhou,China,510080 [82]Sun Yat-Sen Memorial Hospital Sun Yat-sen University,Guangzhou,China,510120 [83]Zhejiang Cancer Hospital,Hang Zhou,China,310022 [84]Second Affiliated Hospital, School of Medicine, Zhejiang University,Hangzhou,China,310009 [85]The Second Affiliated Hospital of Zhejiang University College of Medicine,Hangzhou,China,310009 [86]Sir Run Run Shaw Hospital, Zhejiang University School of Medicine,Hangzhou,China,310016 [87]Harbin medical university cancer hospital,Harbin,China,150000 [88]Huizhou Municipal Central Hospital,Huizhou,China,516001 [89]Taizhou Hospital of Zhejiang Province,Linhai,China,317000 [90]Affiliated Hospital of North Sichuan Medical College,Nanchong,China [91]Ruijin Hospital, Shanghai Jiao Tong University,Shanghai,China,200025 [92]Fudan University Shanghai Cancer Center,Shanghai,China,200032 [93]Shanghai East Hospital,Shanghai,China,310000 [94]Shenzhen university General Hospital,Shenzhen,China,518055 [95]Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen,China,518116 [96]Tianjin Medical University General Hospital,Tianjin,China,300052 [97]Weifang People''s Hospital,Weifang,China,261000 [98]The First Affiliated Hospital of Xi''an Jiaotong University,Xi''an,China,710061 [99]Yantai Yuhuangding Hospital,Yantai,China,264000 [100]Daping Hospital Army Characteristic Medical Center,Yuzhong District,China,400042 [101]Henan Cancer Hospital,Zhengzhou,China,450008 [102]Fakultni nemocnice Olomouc - I.P.Pavlova 6,Olomouc,Czechia,775 20 [103]Vitkovicka nemocnice a.s.,Ostrava- Vitkovice,Czechia,70300 [104]Fakultni nemocnice Plzen,Plzen,Czechia,30599 [105]Rigshospitalet,Copenhagen,Denmark,DK-2100 [106]Institut Sainte Catherine,Avignon Cedex 9,France,84918 [107]Hospices Civils de Lyon HCL,Bron,France,69500 [108]CHU de Grenoble - Hopital Albert Michallon,La Tronche,France,38700 [109]Centre Hospitalier du Mans,le Mans,France,72000 [110]CHR Hôpital Calmette,Lille,France,59000 [111]Hopital Nord,Marseille Cedex 20,France,13915 [112]CHU de Montpellier - Arnaud de Villeneuve,Montpellier Cedex 5,France,34295 [113]Institut Curie,Paris,France,75005 [114]CHU Bordeaux,Pessac,France,33604 [115]CHRU Hopital de Pontchaillou,Rennes,France,35033 [116]CHU Nantes,Sain-Herblain,France,44800 [117]Nouvel Hopital Civil - CHU Strasbourg,Strasbourg cedex,France,67091 [118]CHU Bretonneau,Tours,France,37000 [119]Evangelische Lungenklinik Berlin,Berlin,Germany,13125 [120]Asklepios Klinikum Harburg,Hamburg,Germany,21075 [121]Thoraxklinik am Universitätsklinikum Heidelberg,Heidelberg,Germany,69126 [122]Onkologische Schwerpunktpraxis,Heilbronn,Germany,74072 [123]POIS Sachsen GmbH iG,Leipzig,Germany,04357 [124]Bethanien Krankenhaus,Moers,Germany,47441 [125]Klinikum der Universitaet Muenchen,München,Germany,80336 [126]Oncologianova GmbH,Recklinghausen,Germany,45659 [127]Universitaetsklinikum Regensburg,Regensburg,Germany,93053 [128]Queen Mary Hospital,Hong Kong,Hong Kong,999077 [129]Health Care Global Enterprises pvt Ltd,Bangalore,India,560027 [130]Artemis Hospital,Gurugram,India,122001 [131]Tata Medical Center,Kolkata,India,700160 [132]Tata Memorial Hospital,Mumbai,India,400012 [133]HCG Manavta Cancer Centre,Nasik,India,422002 [134]Rajiv Gandhi Cancer Institute and Research Centre,New Delh,India,110085 [135]Noble Hospital Pvt Ltd,Pune,India,411013 [136]Bhaktivedanta Hospital & Research Institute,Thane,India,411107 [137]Soroka University Medical Center,Beersheba,Israel,84101 [138]Rambam Health Corporation,Haifa,Israel,3109601 [139]Shaare Zedek Medical Center,Jerusalem,Israel,91031 [140]Meir Medical Center,Kfar Saba,Israel,44281 [141]Rabin Medical Center,Petah Tikva,Israel,49100 [142]Chaim Sheba Medical Center,Ramat Gan,Israel,5262100 [143]Tel-Aviv Sourasky Medical Center,Tel-Aviv,Israel,6423906 [144]CRO, IRCCS, Istituto Nazionale Tumori,Aviano,Italy,33081 [145]Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori,Meldola,Italy,47014 [146]Istituto Europeo di Oncologia,Milano,Italy,20141 [147]Ospedale S. Maria Delle Croci,Ravenna,Italy,48121 [148]Istituto Nazionale Tumori Regina Elena,Roma,Italy,00144 [149]Policlinico G.B.Rossi,Verona,Italy,37134 [150]National Hospital Organization Shibukawa Medical Center,Gunma,Japan,377-0280 [151]Kobe City Medical Center General Hospital,Hyogo,Japan,650-0047 [152]Hyogo Cancer Center,Hyogo,Japan,673-8558 [153]Kanagawa Cancer Center,Kanagawa,Japan,241-8515 [154]Kurume University Hospital,Kurume,Japan,830-0011 [155]National Hospital Organization Nagoya Medical Center,Nagoya-shi,Japan,460-0001 [156]Niigata Cancer Center Hospital,Niigata,Japan,951-8566 [157]Osaka International Cancer Institute,Osaka,Japan,541-8567 [158]Shizuoka Cancer Center,Shizuoka,Japan,411-8777 [159]Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital,Tokyo,Japan,113-8677 [160]The Cancer Institute Hospital of JFCR,Tokyo,Japan,135-8550 [161]Ehime University Hospital,Toon-shi,Japan,791-0295 [162]Wakayama Medical University Hospital,Wakayama,Japan,641-8510 [163]National Hospital Organization Iwakuni Clinical Center,Yamaguchi,Japan,740-8510 [164]National Hospital Organization Yamaguchi Ube Medical Center,Yamaguchi,Japan,755-0241 [165]National Cancer Center,Gyeonggi-do,Korea, Republic of,10408 [166]CHA Bundang Medical Center, CHA University,Gyeonggi-do,Korea, Republic of,13496 [167]Seoul National University Bundang Hospital,Gyeonggi-do,Korea, Republic of,13620 [168]GyeongSang National University Hospital,Gyeongsangnam-do,Korea, Republic of,52727 [169]Korea University Anam Hospital,Seoul,Korea, Republic of,02841 [170]Severance Hospital, Yonsei University Health System,Seoul,Korea, Republic of,03722 [171]Asan Medical Center,Seoul,Korea, Republic of,05505 [172]Samsung Medical Center,Seoul,Korea, Republic of,06351 [173]The Catholic University of Korea, Seoul St. Mary''s Hospital,Seoul,Korea, Republic of,06591 [174]University Malaya Medical Centre,Kuala Lumpur,Malaysia [175]Hospital Tengku Ampuan Afzan,Kuantan,Malaysia,25100 [176]Beacon Hospital Sdn. Bhd.,Petaling Jaya,Malaysia,46050 [177]Subang Jaya Medical Centre,Subang Jaya,Malaysia,47500 [178]Mount Miriam Cancer Hospital,Tanjung Bungah,Malaysia,11200 [179]Hospital Civil de Guadalajara Fray Antonio Alcalde,Guadalajara,Mexico,44280 [180]CIMOVA, Morals Vargas Centro de Investigación SC,Leon,Mexico,37000 [181]Health Pharma Professional Research,Mexico,Mexico,03100 [182]Instituto Nacional de Cancerologia,Mexico,Mexico,14080 [183]Oncologia Integral Satelite,Naucalpan,Mexico,53100 [184]VUMC Amsterdam,Amsterdam,Netherlands,1081 HV [185]Ziekenhuis St Jansdal,Harderwijk,Netherlands,3844 DG [186]Erasmus MC,Rotterdam,Netherlands,3015 GD [187]Centrum Onkologii im. Prof. F. Lukaszczyka,Bydgoszcz,Poland,85-796 [188]Uniwersyteckie Centrum Kliniczne,Gdansk,Poland,80-952 [189]Szpitale Pomorskie Sp. Z o.o.,Gdynia,Poland,81-519 [190]Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie,Olsztyn,Poland,10-357 [191]Wielkopolskie Centrum Pulmonologii I Torakochirurgii im. Eugenii I Janusza Zeylandow,Poznan,Poland,60-569 [192]Private Specialist Hospitals - MedPolonia,Poznan,Poland,60-693 [193]Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy,Warszawa,Poland,02-781 [194]Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente,Lisboa,Portugal,1769-001 [195]Hospital Beatriz Angelo,Loures,Portugal,2674-514 [196]Centro Hospitalar Universitario do Porto, EPE,Porto,Portugal,4099-001 [197]Instituto Portugues de Oncologia,Porto,Portugal,4200072 [198]Pan American Center for Oncology Trials LLC,Rio Piedras,Puerto Rico,00917 [199]City Clinical Hospital #1,Nalchik,Russian Federation,360000 [200]Llc, Eurocityclinic,Saint Petersburg,Russian Federation,197022 [201]Hosp. Univ. A Coruña,A Coruña,Spain,15006 [202]Hosp. de La Santa Creu I Sant Pau,Barcelona,Spain,08025 [203]Hosp. Univ. Quiron Dexeus,Barcelona,Spain,08028 [204]Hosp. Univ. Vall D Hebron,Barcelona,Spain,08035 [205]Hosp. 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I Politecni La Fe,Valencia,Spain,46026 [218]Sahlgrenska Universitetssjukhuset,Goteborg,Sweden,413 45 [219]Linkoping University Hospital,Linkoping,Sweden,581 85 [220]Skanes universitetssjukhus,Lund,Sweden,221 85 [221]Norrlands Universitetssjukhus,Umea,Sweden,901 85 [222]Akademiska Sjukhuset,Uppsala,Sweden,75181 [223]Changhua Christian Hospital,Changhua,Taiwan,500 [224]Kaohsiung Medical University Chung-Ho Memorial Hospital,Kaohsiung,Taiwan,807 [225]Taipei Medical University Shuang Ho Hospital,New Taipei City,Taiwan,23561 [226]Chung Shan Medical University Hospital,Taichung,Taiwan,402 [227]Taichung Veterans General Hospital,Taichung,Taiwan,40705 [228]National Cheng Kung University Hospital,Tainan,Taiwan,704 [229]National Taiwan University Hospital,Taipei,Taiwan,100 [230]Adana City Hospital,Adana,Turkey,01060 [231]Memorial Ankara Hastanesi,Ankara,Turkey,06520 [232]Gazi University Hospital,Ankara,Turkey,06560 [233]Ankara Bilkent City Hospital,Ankara,Turkey,06590 [234]Trakya University Medical Faculty,Edirne,Turkey,22030 [235]Istanbul University Cerrahpasa Medical Faculty,Istanbul,Turkey,34098 [236]Bakirkoy Training and Research Hospital,Istanbul,Turkey,34147 [237]Medipol Mega University Hospital,Istanbul,Turkey,34214 [238]Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi,Istanbul,Turkey,34722 [239]Izmir Medical Park Hospital,Izmir,Turkey,35575 [240]Velindre Hospital,Cardiff,United Kingdom,CF14 2TL [241]Edinburgh Cancer Centre Western General,Edinburgh,United Kingdom,EH4 2XU [242]UCL Cancer Institute,London,United Kingdom,NW1 2PG [243]Guy''s and St Thomas'' NHS Foundation Trust,London,United Kingdom,SE1 9RT [244]The Royal Marsden NHS Trust,London,United Kingdom,SW3 6JJ [245]The Christie Nhs Foundation Trust,Manchester,United Kingdom,M20 4BX

研究目的:
The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data.

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