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eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients

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研究单位: [1]Xcovery Holding Company, LLC [2]Moffitt Cancer Center Tampa, Florida, United States, 33612 [3]University Cancer & Blood Center Athens, Georgia, United States, 30607 [4]Kaiser Permanente Hawaii- Moanalua Medical Center Honolulu, Hawaii, United States, 96819 [5]Saint Alphonsus Regional Medical Center Boise, Idaho, United States, 83706 [6]Henry Ford Hospital Detroit, Michigan, United States, 48202 [7]Washington University School of Medicine Saint Louis, Missouri, United States, 63110 [8]North Shore Hematology-Oncology Associates, PC East Setauket, New York, United States, 11733 [9]Providence Portland Medical Center Portland, Oregon, United States, 97213 [10]Vanderbilt University Nashville, Tennessee, United States, 37240 [11]Inova Schar Cancer Institute Fairfax, Virginia, United States, 22031 [12]Providence Regional Cancer System Lacey, Washington, United States, 98503 [13]University of Wisconsin Clinical Science Center Madison, Wisconsin, United States, 53792 [14]CEMIC Buenos Aires, Argentina [15]Fundacion Favaloro Caba, Argentina [16]Centro de Investigacion Pergamino SA Pergamino, Argentina [17]Sanatorio Parque S.A. Rosario, Argentina [18]Border Medical Oncology Research Unit Albury, New South Wales, Australia, 2640 [19]Chris O'Brien Lifehouse Camperdown, New South Wales, Australia [20]Princess Alexandra Hospital Woolloongabba, Queensland, Australia [21]Chris O Brien Lifehouse Camperdown, Australia [22]Princess Alexandra Hospital Woolloongabba, Australia [23]UZ Brussel Brussels, Belgium, 1090 [24]CHU UCL Namur Yvoir, Belgium, 5530 [25]Instituto do Câncer do Estado de São Paulo São Paulo, SP, Brazil, 01246-000 [26]Hospital de Câncer de Barretos - Fundação Pio XII São Paulo, SP, Brazil, 14784-400 [27]Hospital Haroldo Juaçaba - Instituto do Cancêr do Ceará Fortaleza, Brazil, 60351-010 [28]Núcleo de Oncologia da Bahia - NOB Salvador, Brazil, 40170-110 [29]Fundacao do ABC Faculdade de Medicina do ABC Santo André, Brazil, 09060-650 [30]Hospital Paulistano São Paulo, Brazil, 01321 [31]Cross Cancer Institute Edmonton, Alberta, Canada, T6G 1Z2 [32]Infirmière recherche Clinique, IUCPQ Quebec City, Quebec, Canada, G1V 4G5 [33]Anhui Provincial Hospital Hefei, Anhui, China, 230001 [34]Beijing Chao Yang Hospital Beijing, Beijing, China, 100020 [35]Peking Union Medical College Hospital Beijing, Beijing, China, 100032 [36]Peking University Cancer Hospital Beijing, Beijing, China, 100142 [37]Beijing Chest Hospital,Capital Medical University Beijing, Beijing, China, 101149 [38]Fujian Provincial Cancer Hospital Fuzhou, Fujian, China, 350014 [39]Guangdong General Hospital Guangzhou, Guangdong, China, 510080 [40]Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 050011 [41]Union Hospital of Tongji Medical College of Huazhong Science and Techology University Wuhan, Hubei, China, 420104 [42]Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan, Hubei, China, 430030 [43]Hubei Cancer Hospital Wuhan, Hubei, China, 430079 [44]Hunan Cancer Hospital Changsha, Hunan, China, 410006 [45]Nanjing General Hospital Nanjing, Jiangsu, China, 210002 [46]The Second Affiliated Hospital of Nanchang University Nanchang, Jiangxi, China, 330006 [47]The First Bethune Hospital of Jilin University Changchun, Jilin, China, 130000 [48]Jilin Cancer Hospital Changchun, Jilin, China, 130012 [49]The First Hospital of China Medical University Shenyang, Liaoning, China, 110001 [50]The Affiliated Hospital of Qingdao University Qingdao, Shandong, China, 266071 [51]Shanghai Chest Hospital Shanghai, Shanghai, China, 200030 [52]West China Hospital, Sichuan University Chengdu, Sichuan, China, 610041 [53]Tianjin Medical University General Hospital Mailing No.154 Anshan Avenue Heping District Tianjin, Tianjin, China, 300052 [54]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022 [55]Beijing Cancer Hospital Beijing, China, 100142 [56]Peking University Cancer Hospital Beijing, China, 100142 [57]Beijing Cancer Hospital Beijing, China [58]The First Affiliated Hospital, Zhejiang University Hangzhou, China [59]Zhejiang Cancer Hospital Hangzhou, China [60]Vítkovická Nemocnice , a.s. Ostrava-Vitkovice, Czechia, 70384 [61]Nemocnice Na Pleši s.r.o. Plesice, Czechia, 26204 [62]Krajská zdravotní, a.s., Masarykova nemocnice Usti nad Labem, Czechia, 40113 [63]Hopital Morvan CHRU de Brest Brest, France, 29200 [64]Centre GF Leclerc Dijon, France, 21000 [65]CHRU Lille Lille, France, 59000 [66]ICM Val d'Aurelle Montpellier, France, 34298 [67]Hôpital Saint-Louis Paris, France, 75010 [68]CHU de Rennes Hôpital Pontchaillou Rennes, France, 35033 [69]Institut de Cancérologie de l'Ouest (ICO) Saint Herblain, France, 44805 [70]Nouvel Hospital Civil de Stasbourg Strasbourg, France, 67091 [71]Klinik m. S. Infektiologie & Pneumologie Berlin, Germany, 13353 [72]Vivantes Klinikum Neukölln Berlin, Germany, D-12351 [73]Lungen Clinic Grosshansdorf Grosshansdorf, Germany, 22927 [74]Klinik Löwenstein gGmbH Med. Klinik II Onkologie Lowenstein, Germany, 74245 [75]Praxis Hämatologie und Onkologie Stolberg Stolberg, Germany, D-52222 [76]Queen Elizabeth Hospital Hong Kong, Hong Kong [77]The University of Hong Kong, Queen Mary Hospital Hong Kong, Hong Kong [78]The University of Hong Kong/Queen Mary Hospital Hong Kong, Hong Kong [79]Prince of Wales Hospital Sha Tin, Hong Kong [80]Soroka Medical Centre Be'er Sheva', Israel, 84101 [81]Rambam Health Care Campus/ Oncology Institute Haifa, Israel, 31096 [82]Hadassah Medical Center Jerusalem, Israel, 9112001 [83]Rabin Medical Center Institute of Oncology, Davidoff Center Petah Tiqva, Israel, 49100 [84]Chaim Sheba Medical Center Ramat Gan, Israel, 5262000 [85]Centro Riferimento Oncologico CRO Aviano Aviano, Italy, 33081 [86]Ospedale Mater Salutis Legnago, Italy, 37045 [87]IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola, Italy, 47014 [88]IEO Istituto Europeo di Oncologia Milano, Italy, 20141 [89]AOU Federico II, Oncologia Medica Napoli, Italy, 80131 [90]Centro Operativo Studi Clinici S.C.Oncologia Medica Perugia, Italy, 06132 [91]UOC Oncologia Medica Ravenna, Italy, 48121 [92]Istituto Clinico Humanitas IRCCS Rozzano, Italy, 20089 [93]Azienda Socio Sanitaria Territoriale (ASST) della Valtellina e dell'Alto Laria Sondrio, Italy, 20121 [94]Seoul National University Hospital Seoul, Korea, Republic of, 03080 [95]Asan Medical Center Seoul, Korea, Republic of, 05505 [96]VU Medical Center Amsterdam, Netherlands, 1007 MB [97]Maastricht University Medical Centre (MUMC) Maastricht, Netherlands, 6229HX [98]Clínica Ricardo Palma Lima, Peru [99]Medical University of Gdansk Gdańsk, Poland [100]Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Warsaw, Poland [101]Federal State Budgetary Scientific Institution Russian Oncological Scientific Center named after N.N. Blokhin Moscow, Russian Federation, 115478 [102]LLC "Vitamed" Moscow, Russian Federation, 121309 [103]State Budgetary Institution of Healthcare of the city of Moscow "MOSCOW CITY ONCOLOGY HOSPITAL # 62" Moscow, Russian Federation, 143423 [104]BHI of Omsk region "Clinical Oncology Dispensary" Omsk, Russian Federation [105]Pavlov First Medical University Saint Petersburg, Russian Federation, 197022 [106]FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" Saint Petersburg, Russian Federation [107]Clinica Universidad de Navarra Pamplona, Navarra, Spain, 31008 [108]Hospital Universitario Infanta Cristina Badajoz, Spain, 06080 [109]Hospital del Mar Barcelona, Spain, 08003 [110]Hospital de la Santa Creu i Sant Pau Barcelona, Spain, 08025 [111]Hospital Universitario Quirón Dexeus Barcelona, Spain, 08028 [112]Hospital Vall d'Hebrón Barcelona, Spain, 08035 [113]Hospital Parc Tauli' Barcelona, Spain, 08208 [114]ICO Girona - Hospital Doctor Josep Trueta Girona, Spain, 17007 [115]Hospital General Universitario Gregorio Marañon Madrid, Spain [116]Hospital Son Ltatzer Palma de Mallorca, Spain, 07198 [117]Trakya University Balkan Oncology Hospital Edirne, Turkey, 22030 [118]Istanbul University Cerrahpasa Medical Faculty Istanbul, Turkey, 34098 [119]Ege University Medical Faculty Izmir, Turkey, 35100 [120]Blackpool Victoria Hospital Blackwood, United Kingdom, FY3 8NR [121]Southmead Hospital Bristol, United Kingdom, BS10 5NB [122]Kings Mill hospital Nottingham, United Kingdom, NG17 4JL [123]The Clatterbridge Cancer Centre NHS Foundation Trust Wirral, United Kingdom, CH63 4JY [124]Mayo Clinic Phoenix, Arizona, United States, 85054

关键词: ALK-positive NSCLC

研究目的:
The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.

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