Исследование комбинированной терапии амивантамабом и лазертинибом по сравнению с осимертинибом при местнораспространенном или метастатическом немелкоклеточном раке легкого (MARIPOSA)
2 ноября 2026 г. обновлено: Janssen Research & Development, LLC
Фаза 3, рандомизированное исследование комбинированной терапии амивантамабом и лазертинибом по сравнению с осимертинибом по сравнению с лазертинибом в качестве терапии первой линии у пациентов с местнораспространенным или метастатическим немелкоклеточным раком легкого с мутацией EGFR.
The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Обзор исследования
Статус
Активный, не рекрутирующий
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
1074
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Bedford Park, Австралия, 5042
- Flinders Medical Centre
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Heidelberg, Австралия, 3084
- Austin Hospital
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Malvern, Австралия, 3144
- Cabrini Medical Centre
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Murdoch, Австралия, 6150
- St John of God Hospital Murdoch
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Nedlands, Австралия, 6009
- Sir Charles Gairdner Hospital
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Westmead, Австралия, 2145
- Westmead Hospital
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Wollongong, Австралия, 2500
- Southern Medical Day Care Centre
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Woolloongabba, Австралия, 4102
- Princess Alexandra Hospital
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Buenos Aires, Аргентина, C1428ANZ
- Instituto Alexander Fleming
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Buenos Aires, Аргентина, C1426AGE
- Centro Oncológico Korben
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Córdoba, Аргентина, X5016KEH
- Hospital Privado Centro Medico de Cordoba
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La Rioja, Аргентина, F5300COE
- Centro Oncologico Riojano Integral (Cori)
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Viedma, Аргентина, R8500ACE
- Clínica Viedma
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Brussels, Бельгия, 1200
- Cliniques Universitaires Saint Luc
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Charleroi, Бельгия, 6060
- Grand Hopital De Charleroi Site Les Viviers
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Leuven, Бельгия, 3000
- UZ Leuven
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Ottignies, Бельгия, 1340
- Clinique Saint Pierre
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Roeselare, Бельгия, 8800
- Algemeen Ziekenhuis Delta
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Barretos, Бразилия, 14784-400
- Fundacao Pio XII
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Belo Horizonte, Бразилия, 30110-022
- Cetus Oncologia
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Florianópolis, Бразилия, 88020-210
- Ynova Pesquisa Clinica
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Ijuí, Бразилия, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Natal, Бразилия, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Pelotas, Бразилия, 96020 080
- UPCO Unidade de Pesquisa Clinica em Oncologia
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Porto Alegre, Бразилия, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Бразилия, 90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Rio de Janeiro, Бразилия, 22 250 905
- Oncoclinicas Rio de Janeiro S A
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Rio de Janeiro, Бразилия, 20231 050
- Ministerio da Saude Instituto Nacional do Cancer
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Rio de Janeiro, Бразилия, 22281 100
- IDOR - Regional Rio de Janeiro
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Sorocaba, Бразилия, 18030-075
- IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
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São Paulo, Бразилия, 04014-002
- Núcleo de Pesquisa São Camilo
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São Paulo, Бразилия, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Бразилия, 01246 000
- Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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Vitória, Бразилия, 29308-014
- Hospital Evangélico de Cachoeiro de Itapemirim
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Budapest, Венгрия, H-1529
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
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Farkasgyepü, Венгрия, 8582
- Veszprém Megyei Tudőgyógyintézet
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Gyöngyös, Венгрия, 3233
- Mátrai Gyógyintézet-Bronchológia
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Szombathely, Венгрия, 9700
- Markusovszky Egyetemi Oktatokorhaz
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Székesfehérvár, Венгрия, 8000
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
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Törökbálint, Венгрия, 2045
- Tudogyogyintezet Torokbalint
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Bad Berka, Германия, 99437
- Zentralklinik Bad Berka GmbH
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Berlin, Германия, 14165
- Helios Klinikum Emil von Behring GmbH
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Cologne, Германия, 51109
- Kliniken der Stadt Koeln gGmbH
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Essen, Германия, 45147
- Universitaetsklinikum Essen
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Gauting, Германия, 82131
- Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
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Halle, Германия, 06120
- Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
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Heidelberg, Германия, 69126
- Thoraxklinik am Universitatsklinikum Heidelberg
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Heilbronn, Германия, 74072
- Onkologische Schwerpunktpraxis
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Leipzig, Германия, 04357
- POIS Leipzig GbR
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Oldenburg, Германия, 26121
- Pius-Hospital Oldenburg
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Stuttgart, Германия, 70376
- Robert-Bosch-Krankenhaus - Klinik Schillerhoehe
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Haifa, Израиль, 3109601
- Rambam Health Corporation
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Jerusalem, Израиль, 9112001
- Hadassah Medical Center
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Kfar Saba, Израиль, 44281
- Meir Medical Center
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Petah Tikva, Израиль, 49100
- Rabin Medical Center
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Ramat Gan, Израиль, 5262100
- Chaim Sheba Medical Center
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Tel Aviv, Израиль, 6423906
- Tel Aviv Sourasky Medical Center
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Hyderabad, Индия, 500034
- Basavatarakam Indo-American Hospital
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Kolkata, Индия, 700160
- Tata Medical Center
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Mumbai, Индия, 400012
- Tata Memorial Hospital
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Nashik, Индия, 422002
- HCG Manavta Cancer Centre
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Pune, Индия, 411013
- Noble Hospital Pvt Ltd
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A Coruña, Испания, 15006
- Hosp Univ A Coruna
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Badalona, Испания, 08916
- Inst. Cat. D'Oncologia-Badalona
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Barcelona, Испания, 08025
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Испания, 08028
- Hosp. Univ. Quiron Dexeus
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Barcelona, Испания, 08035
- Hosp Univ Vall D Hebron
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Burgos, Испания, 09003
- Hosp. Univ. de Burgos
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Girona, Испания, 17007
- Institut Català D'Oncologia Girona
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Madrid, Испания, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Испания, 28046
- Hosp. Univ. La Paz
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Madrid, Испания, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Majadahonda, Испания, 28222
- Hosp. Univ. Pta. de Hierro Majadahonda
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Málaga, Испания, 29011
- Hosp Regional Univ de Malaga
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Pamplona, Испания, 31008
- Clinica Univ. de Navarra
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Seville, Испания, 41013
- Hosp. Virgen Del Rocio
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Valencia, Испания, 46014
- Hosp. Gral. Univ. Valencia
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Zaragoza, Испания, 50009
- Hosp. Clinico Univ. Lozano Blesa
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Avellino, Италия, 83100
- Ospedale San Giuseppe Moscati di Avellino
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Catania, Италия, 95123
- Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
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Meldola, Италия, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Италия, 20141
- Istituto Europeo di Oncologia
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Milan, Италия, 20132
- IRCCS Ospedale San Raffaele
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Milan, Италия, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Италия, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Monza, Италия, 20052
- San Gerardo Hospital
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Naples, Италия, 80100
- Ospedale Monaldi
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Orbassano, Италия, 10043
- Aou San Luigi Gonzaga
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Ravenna, Италия, 48121
- Ospedale S. Maria Delle Croci
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Roma, Италия, 00168
- Irccs Gemelli
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Rozzano, Италия, 20089
- Istituto Clinico Humanitas
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Ontario
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Brampton, Ontario, Канада, L6R 3J7
- William Osler Health System
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Hamilton, Ontario, Канада, L8V 5C2
- Juravinski Cancer Centre
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Ottawa, Ontario, Канада, K1H 8L6
- The Ottawa Hospital Cancer Centre
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Quebec
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Montreal, Quebec, Канада, H4A 3J1
- McGill University Health Centre
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Beijing, Китай, 100853
- Chinese PLA General Hospital
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Beijing, Китай, 100050
- Beijing Friendship Hospital Capital Medical University
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Beijing, Китай, 100142
- Beijing Cancer Hospital Respiratory Medicine Department II
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Beijing, Китай, 100142
- Beijing Cancer Hospital Respiratory Medicine Department I
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Beijing, Китай, 101149
- Beijing Chest hospital, Capital medical university
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Changchun, Китай, 130000
- Jilin cancer hospital
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Changsha, Китай, 410013
- Hunan Cancer hospital Thoracic Medicine Department II
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Changsha, Китай, 410013
- Hunan Cancer hospital Thoracic Medicine Department I
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Changzhou, Китай, 213003
- The First People's Hospital Of Changzhou
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Chengdu, Китай, 610041
- Sichuan Cancer Hospital
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Chengdu, Китай, 610041
- West China Hospital Sichuan University
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Chongqing, Китай, 400038
- Southwest Hospital
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Guangzhou, Китай, 510080
- The First Affiliated Hospital Sun Yat sen University
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Guangzhou, Китай, 510120
- Sun Yat-Sen Memorial Hospital Sun Yat-sen University
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Hangzhou, Китай, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Китай, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Hangzhou, Китай, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hangzhou, Китай, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Harbin, Китай, 150000
- Harbin medical university cancer hospital
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Huizhou, Китай, 516001
- Huizhou Municipal Central Hospital
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Linhai, Китай, 317000
- Taizhou Hospital of Zhejiang Province
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Nantong, Китай, 226300
- Nantong Tumor Hospital
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Shanghai, Китай, 200030
- Shanghai Chest Hospital
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Shanghai, Китай, 200032
- Fudan University Shanghai Cancer Center
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Shanghai, Китай, 200123
- Shanghai East Hospital
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Shanghai, Китай, 200025
- Ruijin Hospital Shanghai Jiao Tong University
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Shenyang, Китай, 110004
- Shengjing Hospital Of China Medical University
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Tianjin, Китай, 300052
- Tianjin Medical University General Hospital
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Wenzhou, Китай, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Китай, 430030
- TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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Xi'an, Китай, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Yantai, Китай, 264000
- Yantai Yuhuangding Hospital
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Zhengzhou, Китай, 450008
- Henan Cancer Hospital
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Ürümqi, Китай, 830000
- Cancer Hospital of Xinjiang Medical University
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George Town, Малайзия, 10990
- Hospital Pulau Pinang
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Johor Bahru, Малайзия, 81100
- Hospital Sultan Ismail
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Kuala Lumpur, Малайзия, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Малайзия, 59100
- University Malaya Medical Centre
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Kuantan, Малайзия, 25100
- Hospital Tengku Ampuan Afzan
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Petaling Jaya, Малайзия, 46050
- Beacon Hospital Sdn Bhd
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Guadalajara, Мексика, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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León, Мексика, 37000
- CIMOVA, Morals Vargas Centro de Investigación SC
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Mexico City, Мексика, 14050
- Médica Sur
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Mexico City, Мексика, 03100
- Mexico Centre for Clinical Research, S.A. de C.V.
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Monterrey, Мексика, 64710
- i Can Oncology Center
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México, Мексика, 14080
- Instituto Nacional de Cancerologia
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México, Мексика, 03100
- Health Pharma Professional Research
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Naucalpan, Мексика, 53100
- Oncologia Integral Satelite
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's-Hertogenbosch, Нидерланды, 5223 GZ
- Jeroen Bosch Ziekenhuis
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Arnhem, Нидерланды, 6815 AD
- Rijnstate Ziekenhuis
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Harderwijk, Нидерланды, 3844 DG
- Ziekenhuis St Jansdal
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Nijmegen, Нидерланды, 6525AG
- UMC Radboud
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Bydgoszcz, Польша, 85 796
- Centrum Onkologii im Prof F Lukaszczyka
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Gdansk, Польша, 80 214
- Uniwersyteckie Centrum Kliniczne
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Gdynia, Польша, 81 519
- Szpitale Pomorskie Sp z o o
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Olsztyn, Польша, 10-357
- Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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Poznan, Польша, 60-693
- Private Specialist Hospitals - MedPolonia
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Warsaw, Польша, 02-781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Lisbon, Португалия, 1769-001
- Uls Santa Maria - Hosp. Pulido Valente
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Porto, Португалия, 4200-072
- Instituto Portugues de Oncologia
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Porto, Португалия, 4099-001
- Uls Santo Antonio - Hosp. Santo Antonio
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Porto, Португалия, 4100 180
- Hosp. Cuf Porto
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Rio Piedras, Пуэрто-Рико, 00935
- Pan American Center for Oncology Trials LLC
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Irkutsk, Россия, 664035
- Irkutsk Regional Oncology Dispensary
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Krasnoyarsk, Россия, 660133
- Krasnoyarsk Regional Oncology Dispensary
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Kuzmolovsky, Россия, 188663
- Leningrad Regional Oncology Dispensary
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Moscow, Россия, 115533
- MCK
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Moscow, Россия, 121205
- Moscow City Oncology Hospital No 62
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Nal'chik, Россия, 360000
- City Clinical Hospital #1
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Nizhny Novgorod, Россия, 603000
- Nizhny Novgorod Regional Oncological Dispensary
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Omsk, Россия, 664013
- Omsk Clinical Oncology Dispensary
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Saint Petersburg, Россия, 197758
- N.N. Petrov Research Institute Of Oncology
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Saint Petersburg, Россия, 196006
- Oncology Medical Clinics AV Medical group
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Saint Petersburg, Россия, 190121
- Current medical technologies
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Tambov, Россия, 392013
- Tambov Regional Oncology Clinical Dispansary
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Tomsk, Россия, 634050
- Tomsk Cancer Research Institute
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Ufa, Россия, 450083
- Bashkir State Medical University
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Yaroslavl, Россия, 150054
- Yaroslavl Regional Clinical Oncology Hospital
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Edinburgh, Соединенное Королевство, EH4 2XU
- Edinburgh Cancer Centre Western General
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London, Соединенное Королевство, NW1 2PG
- UCL Cancer Institute
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London, Соединенное Королевство, SW3 6JJ
- The Royal Marsden NHS Trust
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London, Соединенное Королевство, SW10 9NH
- Chelsea And Westminster Hospital
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Manchester, Соединенное Королевство, M20 4BX
- Christie NHS Foundation Trust
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Nottingham, Соединенное Королевство, NG5 1PB
- Nottingham University Hospitals NHS Trust
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Sutton, Соединенное Королевство, SM2 5PT
- The Royal Marsden NHS Trust 1
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Arizona
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Goodyear, Arizona, Соединенные Штаты, 85395
- Arizona Oncology Associates, PC - HAL
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Yuma, Arizona, Соединенные Штаты, 85364
- Yuma Regional Medical Center
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California
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Long Beach, California, Соединенные Штаты, 90813
- City of Hope Long Beach Elm
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Orange, California, Соединенные Штаты, 92868
- University of California Irvine
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Colorado
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Lone Tree, Colorado, Соединенные Штаты, 80124
- Rocky Mountain Cancer Centers
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Florida
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Jacksonville, Florida, Соединенные Штаты, 32256
- Cancer Specialists of North Florida
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Georgia
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Athens, Georgia, Соединенные Штаты, 30607
- University Cancer And Blood Center LLC
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Louisiana
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Metairie, Louisiana, Соединенные Штаты, 70006
- East Jefferson General Hospital
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Maryland
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Columbia, Maryland, Соединенные Штаты, 21044
- Maryland Oncology Hematology, PA
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Michigan
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Detroit, Michigan, Соединенные Штаты, 48202
- Henry Ford Hospital
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Minnesota
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Edina, Minnesota, Соединенные Штаты, 55435
- Minnesota Oncology Hematology P A
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Rochester, Minnesota, Соединенные Штаты, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Соединенные Штаты, 63110
- Washington University School Of Medicine
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New Jersey
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East Brunswick, New Jersey, Соединенные Штаты, 08816
- Astera Cancer Care
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Oregon
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Eugene, Oregon, Соединенные Штаты, 97401
- Willamette Valley Cancer Institute and Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Соединенные Штаты, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Соединенные Штаты, 37203
- Sarah Cannon Research Institute
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Texas
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Austin, Texas, Соединенные Штаты, 78745
- Texas Oncology P A
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Houston, Texas, Соединенные Штаты, 77030
- Oncology Consultants Texas
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Virginia
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Fairfax, Virginia, Соединенные Штаты, 22031
- Virginia Cancer Specialists
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Bangkok, Таиланд, 10700
- Siriraj Hospital
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Bangkok, Таиланд, 10400
- Phramongkutklao Hospital and Medical College
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Chiang Mai, Таиланд, 50200
- Chiang Mai University
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Songkhla, Таиланд, 90110
- Songklanagarind Hospital, Prince of Songkla University
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Kaohsiung City, Тайвань, 807
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Kaohsiung City, Тайвань, 833
- Chang Gung Medical Foundation
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Kaohsiung City, Тайвань, 824
- E-DA Hospital
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New Taipei City, Тайвань, 23561
- Taipei Medical University Shuang Ho Hospital
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Taichung, Тайвань, 40447
- China Medical University Hospital
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Taichung, Тайвань, 402
- Chung Shan Medical University Hospital
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Tainan, Тайвань, 704
- National Cheng Kung University Hospital
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Taipei, Тайвань, 10002
- National Taiwan University Hospital
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Adana, Турция (Туркие), 01060
- Adana City Hospital
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Adana, Турция (Туркие), 01250
- Başkent University Medical Faculty Adana Application and Research Center
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Ankara, Турция (Туркие), 6800
- Ankara Bilkent City Hospital
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Ankara, Турция (Туркие), 06560
- Gazi Hastanesi
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Edirne, Турция (Туркие), 22030
- Trakya University Medical Faculty
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Istanbul, Турция (Туркие), 34098
- Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
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Istanbul, Турция (Туркие), 34722
- T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
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Istanbul, Турция (Туркие), 34214
- Medipol Mega University Hospital
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Izmir, Турция (Туркие), 35575
- Medical Point
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Konya, Турция (Туркие), 42080
- Necmettin Erbakan University Meram Medical Faculty
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Dnipro, Украина, 49102
- Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
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Kharkiv, Украина, 61070
- Municipal non-profit enterprise 'Regional Center of Oncology'
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Kyiv, Украина, 02091
- Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
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Kyiv, Украина, 03022
- State Nonprofit Enterprise National Cancer Institute
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Uzhhorod, Украина, 88000
- Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
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Bordeaux, Франция, 33000
- Institut Bergonie
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Bron, Франция, 69500
- Hospices Civils de Lyon HCL
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La Tronche, Франция, 38700
- CHU de Grenoble Hopital Albert Michallon
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Lille, Франция, 59000
- Institute Coeur Poumon
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Limoges, Франция, 87000
- CHU de Limoges
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Marseille, Франция, 13915
- Hopital Nord
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Paris, Франция, 75005
- Institut Curie
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Paris, Франция, 75970
- Hopital Tenon
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Pessac, Франция, 33604
- CHU Bordeaux
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Sain-Herblain, Франция, 44800
- CHU Nantes
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Saint-Mandé, Франция, 94163
- HIA Begin
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Tours, Франция, 37000
- CHU Bretonneau
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Villejuif, Франция, 94805
- Institut Gustave Roussy
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Busan, Южная Корея, 48108
- Inje University Haeundae Paik Hospital
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Cheongju-si, Южная Корея, 28644
- Chungbuk National University Hospital
-
Seongnam-si, Южная Корея, 13620
- Seoul National University Bundang Hospital
-
Seoul, Южная Корея, 05505
- Asan Medical Center
-
Seoul, Южная Корея, 03722
- Severance Hospital Yonsei University Health System
-
Seoul, Южная Корея, 06351
- Samsung Medical Center
-
Seoul, Южная Корея, 03181
- Kangbuk Samsung Hospital
-
Seoul, Южная Корея, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
-
Seoul, Южная Корея, 8308
- Korea University Guro Hospital
-
-
-
-
-
Bunkyō City, Япония, 113 8431
- Juntendo University Hospital
-
Chūōku, Япония, 104 0045
- National Cancer Center Hospital
-
Fukuoka, Япония, 810-8563
- National Hospital Organization Kyushu Medical Center
-
Himeji, Япония, 670-8520
- National Hospital Organization Himeji Medical Center
-
Hirakata, Япония, 573 1191
- Kansai Medical University Hospital
-
Kanazawa, Япония, 920 8641
- Kanazawa University Hospital
-
Kashiwa, Япония, 277 8577
- National Cancer Center Hospital East
-
Kurume, Япония, 830-0011
- Kurume University Hospital
-
Matsusaka, Япония, 515-8544
- Matsusaka Municipal Hospital
-
Niigata, Япония, 951-8566
- Niigata Cancer Center Hospital
-
Okayama, Япония, 700 8558
- Okayama University Hospital
-
Osaka Sayama Shi, Япония, 589 8511
- Kindai University Hospital
-
Shibukawa, Япония, 377-0280
- National Hospital Organization Shibukawa Medical Center
-
Tokyo, Япония, 135 8550
- The Cancer Institute Hospital of JFCR
-
Tokyo, Япония, 152 8902
- National Hospital Organization Tokyo Medical Center
-
Toon-shi, Япония, 791-0295
- Ehime University Hospital
-
Toyonaka-shi, Япония, 560-8552
- National Hospital Organization Osaka Toneyama Medical Center
-
Wakayama, Япония, 641 8510
- Wakayama Medical University Hospital
-
Yamaguchi, Япония, 740-8510
- National Hospital Organization Iwakuni Clinical Center
-
Yamaguchi, Япония, 755-0241
- National Hospital Organization Yamaguchi Ube Medical Center
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation
- The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care
- Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis)
- Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level
- Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy
Exclusion Criteria:
- Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease)
- Participant has an active or past medical history of leptomeningeal disease
- Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent
- Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis
- Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib
- Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Treatment Arm A (Open-label): Amivantamab and Lazertinib
Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80*3) orally once daily. |
Participants will receive amivantamab intravenously.
Другие имена:
Participants will receive lazertinib tablets orally.
Другие имена:
|
|
Активный компаратор: Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib
Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80*3) orally once daily. |
Participants will receive osimertinib capsules orally. Participants will receive matching placebo orally. |
|
Экспериментальный: Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib
Participants will receive lazertinib 240 mg (80*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily. |
Participants will receive lazertinib tablets orally.
Другие имена:
Participants will receive matching placebo orally. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Временное ограничение: From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
|
PFS was defined as the time from randomization until the date of objective disease progression based on BICR using RECIST version 1.1 or death (by any cause) the absence of progression, whichever came first. Disease progression was defined using RECIST 1.1 as a 20 percent (%) increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 millimeters (mL). Participants who have not progressed or have not died at the time of analysis were censored at the time of the latest date of their last evaluable RECIST version 1.1 assessment. |
From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Survival (OS)
Временное ограничение: Approximately 60 months (time from the date of randomization until the date of death due to any cause)
|
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause. |
Approximately 60 months (time from the date of randomization until the date of death due to any cause)
|
|
Objective Response Rate (ORR)
Временное ограничение: Approximately 32.8 months
|
ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria. |
Approximately 32.8 months
|
|
Duration of Response (DOR)
Временное ограничение: Approximately 32.8 months
|
DOR is defined as the time from the date of first documented response (CR or PR) until the date of documented progression or death, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST v1.1 criteria. |
Approximately 32.8 months
|
|
Progression-Free Survival After First Subsequent Therapy (PFS2)
Временное ограничение: Approximately 60 months
|
The PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first. |
Approximately 60 months
|
|
Time to Symptomatic Progression (TTSP)
Временное ограничение: Approximately 60 months
|
TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms. |
Approximately 60 months
|
|
Intracranial PFS
Временное ограничение: Approximately 60 months
|
Intracranial PFS is defined as the time from randomization until the date of objective intracranial disease progression or death, whichever comes first, based on BICR using RECIST v1.1. |
Approximately 60 months
|
|
Incidence and Severity of Adverse Events (AEs)
Временное ограничение: Approximately 60 months
|
Incidence and severity of treatment emergent adverse events (TEAEs) will be reported. Any adverse event occurring at or after the initial administration of study treatment through the day of last dose plus 30 days, or until the start of subsequent anticancer therapy (if earlier), is considered to be treatment emergent. |
Approximately 60 months
|
|
Number of Participants With Clinical Laboratory Abnormalities
Временное ограничение: Approximately 60 months
|
Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported. |
Approximately 60 months
|
|
Number of Participants With Vital Signs Abnormalities
Временное ограничение: Approximately 60 months
|
Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported. |
Approximately 60 months
|
|
Number of Participants With Physical Examination Abnormalities
Временное ограничение: Approximately 60 months
|
Number of participants with physical examination abnormalities will be reported. |
Approximately 60 months
|
|
Serum Concentration of Amivantamab
Временное ограничение: Approximately 60 months
|
Serum samples will be analyzed to determine concentrations of Amivantamab. |
Approximately 60 months
|
|
Plasma Concentration of Lazertinib
Временное ограничение: Approximately 60 months
|
Plasma samples will be analyzed to determine concentrations of Lazertinib. |
Approximately 60 months
|
|
Number of Participants With Anti-Amivantamab Antibodies
Временное ограничение: Approximately 60 months
|
Number of participants with antibodies to amivantamab will be reported. |
Approximately 60 months
|
|
Change From Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ)
Временное ограничение: Baseline up to approximately 60 months
|
The NSCLC-SAQ contains 7 items that assess cough, pain, dyspnea, fatigue, and poor appetite over a 7-day recall period. Each multi-item scale and individual item will be summarized using count and percent by visit. |
Baseline up to approximately 60 months
|
|
Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Временное ограничение: Baseline up to approximately 60 months
|
EORTC-QLQ-C30 is a core 30-item questionnaire for evaluating the health-related quality of life (HRQoL) of participants participating in cancer clinical studies. |
Baseline up to approximately 60 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Cho BC, Felip E, Hayashi H, Thomas M, Lu S, Besse B, Sun T, Martinez M, Sethi SN, Shreeve SM, Spira AI. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small-cell lung cancer. Future Oncol. 2022 Feb;18(6):639-647. doi: 10.2217/fon-2021-0923. Epub 2021 Dec 16.
- Cho BC, Lu S, Felip E, Spira AI, Girard N, Lee JS, Lee SH, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Mourao Dias J, Besse B, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Yoshioka H, Yang JC, Thomas M, Nguyen D, Ou SI, Mukhedkar S, Prabhash K, D'Arcangelo M, Alatorre-Alexander J, Vazquez Limon JC, Alves S, Stroyakovskiy D, Peregudova M, Sendur MAN, Yazici O, Califano R, Gutierrez Calderon V, de Marinis F, Passaro A, Kim SW, Gadgeel SM, Xie J, Sun T, Martinez M, Ennis M, Fennema E, Daksh M, Millington D, Leconte I, Iwasawa R, Lorenzini P, Baig M, Shah S, Bauml JM, Shreeve SM, Sethi S, Knoblauch RE, Hayashi H; MARIPOSA Investigators. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024 Oct 24;391(16):1486-1498. doi: 10.1056/NEJMoa2403614. Epub 2024 Jun 26.
- Yang JC, Lu S, Hayashi H, Felip E, Spira AI, Girard N, Kim YJ, Lee SH, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Mourao Dias J, Besse B, Passaro A, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Yoshioka H, Thomas M, Nguyen D, Ou SI, Mukhedkar S, Prabhash K, D'Arcangelo M, Alatorre-Alexander J, Vazquez Limon JC, Alves S, Stroyakovskiy D, Peregudova M, Sendur MAN, Yazici O, Califano R, Gutierrez Calderon V, de Marinis F, Kim SW, Gadgeel SM, Owen S, Xie J, Sun T, Mehta J, Venkatasubramanian R, Ennis M, Fennema E, Daksh M, Roshak A, Man J, Knoblauch RE, Bauml JM, Baig M, Shah S, Sethi S, Cho BC; MARIPOSA Investigators. Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2025 Oct 30;393(17):1681-1693. doi: 10.1056/NEJMoa2503001. Epub 2025 Sep 7.
- Lee SH, Lu S, Hayashi H, Felip E, Spira AI, Girard N, Kim YJ, Ostapenko Y, Danchaivijitr P, Liu B, Alip A, Korbenfeld E, Dias JM, Lee KH, Xiong H, How SH, Cheng Y, Chang GC, Chih-Hsin Yang J, Besse B, Thomas M, Shah S, Baig M, Curtin JC, Zhang J, Xie J, Sun T, Sethi S, Wang M, Fennema E, Daksh M, Ennis M, Bauml JM, Cho BC. Lazertinib Versus Osimertinib in Previously Untreated EGFR-Mutant Advanced NSCLC: A Randomized, Double-Blind, Exploratory Analysis From MARIPOSA. J Thorac Oncol. 2025 Nov;20(11):1655-1668. doi: 10.1016/j.jtho.2025.06.030. Epub 2025 Jul 3.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
30 сентября 2020 г.
Первичное завершение (Действительный)
11 августа 2023 г.
Завершение исследования (Оцененный)
16 февраля 2028 г.
Даты регистрации исследования
Первый отправленный
23 июля 2020 г.
Впервые представлено, что соответствует критериям контроля качества
23 июля 2020 г.
Первый опубликованный (Действительный)
27 июля 2020 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
4 ноября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
2 ноября 2026 г.
Последняя проверка
1 ноября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CR108856
- 2020-000743-31 (Номер EudraCT)
- 73841937NSC3003 (Другой идентификатор: Janssen Research & Development, LLC)
- 2023-506576-27-00 (Идентификатор реестра: EUCT number)
- 2023 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .