Um estudo da terapia combinada de amivantamab e lazertinib versus osimertinib em câncer de pulmão de células não pequenas localmente avançado ou metastático (MARIPOSA)
2 de novembro de 2026 atualizado por: Janssen Research & Development, LLC
Um estudo randomizado de fase 3 da terapia combinada de amivantamab e lazertinib versus osimertinib versus lazertinib como tratamento de primeira linha em pacientes com câncer de pulmão de células não pequenas metastático ou localmente avançado com mutação de 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).
Visão geral do estudo
Status
Ativo, não recrutando
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1074
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bad Berka, Alemanha, 99437
- Zentralklinik Bad Berka GmbH
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Berlin, Alemanha, 14165
- Helios Klinikum Emil von Behring GmbH
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Cologne, Alemanha, 51109
- Kliniken der Stadt Koeln gGmbH
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Essen, Alemanha, 45147
- Universitaetsklinikum Essen
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Gauting, Alemanha, 82131
- Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
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Halle, Alemanha, 06120
- Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
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Heidelberg, Alemanha, 69126
- Thoraxklinik am Universitatsklinikum Heidelberg
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Heilbronn, Alemanha, 74072
- Onkologische Schwerpunktpraxis
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Leipzig, Alemanha, 04357
- POIS Leipzig GbR
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Oldenburg, Alemanha, 26121
- Pius-Hospital Oldenburg
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Stuttgart, Alemanha, 70376
- Robert-Bosch-Krankenhaus - Klinik Schillerhoehe
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Buenos Aires, Argentina, C1428ANZ
- Instituto Alexander Fleming
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Buenos Aires, Argentina, C1426AGE
- Centro Oncológico Korben
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Córdoba, Argentina, X5016KEH
- Hospital Privado Centro Medico de Cordoba
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La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral (Cori)
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Viedma, Argentina, R8500ACE
- Clínica Viedma
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Bedford Park, Austrália, 5042
- Flinders Medical Centre
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Heidelberg, Austrália, 3084
- Austin Hospital
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Malvern, Austrália, 3144
- Cabrini Medical Centre
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Murdoch, Austrália, 6150
- St John of God Hospital Murdoch
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Nedlands, Austrália, 6009
- Sir Charles Gairdner Hospital
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Westmead, Austrália, 2145
- Westmead Hospital
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Wollongong, Austrália, 2500
- Southern Medical Day Care Centre
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Woolloongabba, Austrália, 4102
- Princess Alexandra Hospital
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Barretos, Brasil, 14784-400
- Fundacao Pio XII
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Belo Horizonte, Brasil, 30110-022
- Cetus Oncologia
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Florianópolis, Brasil, 88020-210
- Ynova Pesquisa Clinica
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Ijuí, Brasil, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Natal, Brasil, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Pelotas, Brasil, 96020 080
- UPCO Unidade de Pesquisa Clinica em Oncologia
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Porto Alegre, Brasil, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Brasil, 90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Rio de Janeiro, Brasil, 22 250 905
- Oncoclinicas Rio de Janeiro S A
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Rio de Janeiro, Brasil, 20231 050
- Ministerio da Saude Instituto Nacional do Cancer
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Rio de Janeiro, Brasil, 22281 100
- IDOR - Regional Rio de Janeiro
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Sorocaba, Brasil, 18030-075
- IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
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São Paulo, Brasil, 04014-002
- Núcleo de Pesquisa São Camilo
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São Paulo, Brasil, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brasil, 01246 000
- Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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Vitória, Brasil, 29308-014
- Hospital Evangélico de Cachoeiro de Itapemirim
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Brussels, Bélgica, 1200
- Cliniques Universitaires Saint Luc
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Charleroi, Bélgica, 6060
- Grand Hopital De Charleroi Site Les Viviers
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Leuven, Bélgica, 3000
- UZ Leuven
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Ottignies, Bélgica, 1340
- Clinique Saint Pierre
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Roeselare, Bélgica, 8800
- Algemeen Ziekenhuis Delta
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Ontario
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Brampton, Ontario, Canadá, L6R 3J7
- William Osler Health System
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Hamilton, Ontario, Canadá, L8V 5C2
- Juravinski Cancer Centre
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Ottawa, Ontario, Canadá, K1H 8L6
- The Ottawa Hospital Cancer Centre
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Quebec
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Montreal, Quebec, Canadá, H4A 3J1
- McGill University Health Centre
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Beijing, China, 100853
- Chinese PLA General Hospital
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Beijing, China, 100050
- Beijing Friendship Hospital Capital Medical University
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Beijing, China, 100142
- Beijing Cancer Hospital Respiratory Medicine Department II
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Beijing, China, 100142
- Beijing Cancer Hospital Respiratory Medicine Department I
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Beijing, China, 101149
- Beijing Chest hospital, Capital medical university
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Changchun, China, 130000
- Jilin cancer hospital
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Changsha, China, 410013
- Hunan Cancer hospital Thoracic Medicine Department II
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Changsha, China, 410013
- Hunan Cancer hospital Thoracic Medicine Department I
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Changzhou, China, 213003
- The First People's Hospital Of Changzhou
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Chengdu, China, 610041
- Sichuan Cancer Hospital
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Chengdu, China, 610041
- West China Hospital Sichuan University
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Chongqing, China, 400038
- Southwest Hospital
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Guangzhou, China, 510080
- The First Affiliated Hospital Sun Yat sen University
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Guangzhou, China, 510120
- Sun Yat-Sen Memorial Hospital Sun Yat-sen University
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Hangzhou, China, 310022
- Zhejiang Cancer Hospital
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Hangzhou, China, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Hangzhou, China, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hangzhou, China, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Harbin, China, 150000
- Harbin medical university cancer hospital
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Huizhou, China, 516001
- Huizhou Municipal Central Hospital
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Linhai, China, 317000
- Taizhou Hospital of Zhejiang Province
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Nantong, China, 226300
- Nantong Tumor Hospital
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Shanghai, China, 200030
- Shanghai Chest Hospital
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Shanghai, China, 200123
- Shanghai East Hospital
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Shanghai, China, 200025
- Ruijin Hospital Shanghai Jiao Tong University
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Shenyang, China, 110004
- Shengjing Hospital Of China Medical University
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Tianjin, China, 300052
- Tianjin Medical University General Hospital
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Wenzhou, China, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, China, 430030
- TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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Xi'an, China, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Yantai, China, 264000
- Yantai Yuhuangding Hospital
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Zhengzhou, China, 450008
- Henan Cancer Hospital
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Ürümqi, China, 830000
- Cancer Hospital of Xinjiang Medical University
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Busan, Coréia do Sul, 48108
- Inje University Haeundae Paik Hospital
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Cheongju-si, Coréia do Sul, 28644
- Chungbuk National University Hospital
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Seongnam-si, Coréia do Sul, 13620
- Seoul National University Bundang Hospital
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Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Coréia do Sul, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Seoul, Coréia do Sul, 03181
- Kangbuk Samsung Hospital
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Seoul, Coréia do Sul, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Seoul, Coréia do Sul, 8308
- Korea University Guro Hospital
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A Coruña, Espanha, 15006
- Hosp Univ A Coruna
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Badalona, Espanha, 08916
- Inst. Cat. D'Oncologia-Badalona
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Barcelona, Espanha, 08025
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Espanha, 08028
- Hosp. Univ. Quiron Dexeus
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Barcelona, Espanha, 08035
- Hosp Univ Vall D Hebron
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Burgos, Espanha, 09003
- Hosp. Univ. de Burgos
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Girona, Espanha, 17007
- Institut Català D'Oncologia Girona
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Madrid, Espanha, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Espanha, 28046
- Hosp. Univ. La Paz
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Madrid, Espanha, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Majadahonda, Espanha, 28222
- Hosp. Univ. Pta. de Hierro Majadahonda
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Málaga, Espanha, 29011
- Hosp Regional Univ de Malaga
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Pamplona, Espanha, 31008
- Clinica Univ. de Navarra
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Seville, Espanha, 41013
- Hosp. Virgen Del Rocio
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Valencia, Espanha, 46014
- Hosp. Gral. Univ. Valencia
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Zaragoza, Espanha, 50009
- Hosp. Clinico Univ. Lozano Blesa
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Arizona
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Goodyear, Arizona, Estados Unidos, 85395
- Arizona Oncology Associates, PC - HAL
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Yuma, Arizona, Estados Unidos, 85364
- Yuma Regional Medical Center
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California
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Long Beach, California, Estados Unidos, 90813
- City of Hope Long Beach Elm
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Orange, California, Estados Unidos, 92868
- University of California Irvine
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Colorado
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Lone Tree, Colorado, Estados Unidos, 80124
- Rocky Mountain Cancer Centers
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Florida
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Jacksonville, Florida, Estados Unidos, 32256
- Cancer Specialists of North Florida
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Georgia
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Athens, Georgia, Estados Unidos, 30607
- University Cancer And Blood Center LLC
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
- East Jefferson General Hospital
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Maryland
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Columbia, Maryland, Estados Unidos, 21044
- Maryland Oncology Hematology, PA
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital
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Minnesota
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Edina, Minnesota, Estados Unidos, 55435
- Minnesota Oncology Hematology P A
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School Of Medicine
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New Jersey
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East Brunswick, New Jersey, Estados Unidos, 08816
- Astera Cancer Care
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- Willamette Valley Cancer Institute and Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Research Institute
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Texas
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Austin, Texas, Estados Unidos, 78745
- Texas Oncology P A
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Houston, Texas, Estados Unidos, 77030
- Oncology Consultants Texas
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Virginia Cancer Specialists
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Bordeaux, França, 33000
- Institut Bergonie
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Bron, França, 69500
- Hospices Civils de Lyon HCL
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La Tronche, França, 38700
- CHU de Grenoble Hopital Albert Michallon
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Lille, França, 59000
- Institute Coeur Poumon
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Limoges, França, 87000
- CHU de Limoges
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Marseille, França, 13915
- Hopital Nord
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Paris, França, 75005
- Institut Curie
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Paris, França, 75970
- Hopital Tenon
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Pessac, França, 33604
- CHU Bordeaux
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Sain-Herblain, França, 44800
- CHU Nantes
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Saint-Mandé, França, 94163
- HIA Begin
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Tours, França, 37000
- CHU Bretonneau
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Villejuif, França, 94805
- Institut Gustave Roussy
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's-Hertogenbosch, Holanda, 5223 GZ
- Jeroen Bosch Ziekenhuis
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Arnhem, Holanda, 6815 AD
- Rijnstate Ziekenhuis
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Harderwijk, Holanda, 3844 DG
- Ziekenhuis St Jansdal
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Nijmegen, Holanda, 6525AG
- UMC Radboud
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Budapest, Hungria, H-1529
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
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Farkasgyepü, Hungria, 8582
- Veszprém Megyei Tudőgyógyintézet
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Gyöngyös, Hungria, 3233
- Mátrai Gyógyintézet-Bronchológia
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Szombathely, Hungria, 9700
- Markusovszky Egyetemi Oktatokorhaz
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Székesfehérvár, Hungria, 8000
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
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Törökbálint, Hungria, 2045
- Tudogyogyintezet Torokbalint
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Haifa, Israel, 3109601
- Rambam Health Corporation
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Jerusalem, Israel, 9112001
- Hadassah Medical Center
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Kfar Saba, Israel, 44281
- Meir Medical Center
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Petah Tikva, Israel, 49100
- Rabin Medical Center
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Ramat Gan, Israel, 5262100
- Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Avellino, Itália, 83100
- Ospedale San Giuseppe Moscati di Avellino
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Catania, Itália, 95123
- Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
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Meldola, Itália, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Itália, 20141
- Istituto Europeo di Oncologia
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Milan, Itália, 20132
- IRCCS Ospedale San Raffaele
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Milan, Itália, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Itália, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Monza, Itália, 20052
- San Gerardo Hospital
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Naples, Itália, 80100
- Ospedale Monaldi
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Orbassano, Itália, 10043
- Aou San Luigi Gonzaga
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Ravenna, Itália, 48121
- Ospedale S. Maria Delle Croci
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Roma, Itália, 00168
- Irccs Gemelli
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Rozzano, Itália, 20089
- Istituto Clinico Humanitas
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Bunkyō City, Japão, 113 8431
- Juntendo University Hospital
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Chūōku, Japão, 104 0045
- National Cancer Center Hospital
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Fukuoka, Japão, 810-8563
- National Hospital Organization Kyushu Medical Center
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Himeji, Japão, 670-8520
- National Hospital Organization Himeji Medical Center
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Hirakata, Japão, 573 1191
- Kansai Medical University Hospital
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Kanazawa, Japão, 920 8641
- Kanazawa University Hospital
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Kashiwa, Japão, 277 8577
- National Cancer Center Hospital East
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Kurume, Japão, 830-0011
- Kurume University Hospital
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Matsusaka, Japão, 515-8544
- Matsusaka Municipal Hospital
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Niigata, Japão, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japão, 700 8558
- Okayama University Hospital
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Osaka Sayama Shi, Japão, 589 8511
- Kindai University Hospital
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Shibukawa, Japão, 377-0280
- National Hospital Organization Shibukawa Medical Center
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Tokyo, Japão, 135 8550
- The Cancer Institute Hospital of JFCR
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Tokyo, Japão, 152 8902
- National Hospital Organization Tokyo Medical Center
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Toon-shi, Japão, 791-0295
- Ehime University Hospital
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Toyonaka-shi, Japão, 560-8552
- National Hospital Organization Osaka Toneyama Medical Center
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Wakayama, Japão, 641 8510
- Wakayama Medical University Hospital
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Yamaguchi, Japão, 740-8510
- National Hospital Organization Iwakuni Clinical Center
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Yamaguchi, Japão, 755-0241
- National Hospital Organization Yamaguchi Ube Medical Center
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George Town, Malásia, 10990
- Hospital Pulau Pinang
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Johor Bahru, Malásia, 81100
- Hospital Sultan Ismail
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Kuala Lumpur, Malásia, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Malásia, 59100
- University Malaya Medical Centre
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Kuantan, Malásia, 25100
- Hospital Tengku Ampuan Afzan
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Petaling Jaya, Malásia, 46050
- Beacon Hospital Sdn Bhd
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Guadalajara, México, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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León, México, 37000
- CIMOVA, Morals Vargas Centro de Investigación SC
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Mexico City, México, 14050
- Médica Sur
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Mexico City, México, 03100
- Mexico Centre for Clinical Research, S.A. de C.V.
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Monterrey, México, 64710
- i Can Oncology Center
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México, México, 14080
- Instituto Nacional de Cancerologia
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México, México, 03100
- Health Pharma Professional Research
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Naucalpan, México, 53100
- Oncologia Integral Satelite
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Bydgoszcz, Polônia, 85 796
- Centrum Onkologii im Prof F Lukaszczyka
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Gdansk, Polônia, 80 214
- Uniwersyteckie Centrum Kliniczne
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Gdynia, Polônia, 81 519
- Szpitale Pomorskie Sp z o o
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Olsztyn, Polônia, 10-357
- Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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Poznan, Polônia, 60-693
- Private Specialist Hospitals - MedPolonia
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Warsaw, Polônia, 02-781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Rio Piedras, Porto Rico, 00935
- Pan American Center for Oncology Trials LLC
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Lisbon, Portugal, 1769-001
- Uls Santa Maria - Hosp. Pulido Valente
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Porto, Portugal, 4200-072
- Instituto Portugues de Oncologia
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Porto, Portugal, 4099-001
- Uls Santo Antonio - Hosp. Santo Antonio
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Porto, Portugal, 4100 180
- Hosp. Cuf Porto
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Edinburgh, Reino Unido, EH4 2XU
- Edinburgh Cancer Centre Western General
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London, Reino Unido, NW1 2PG
- UCL Cancer Institute
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London, Reino Unido, SW3 6JJ
- The Royal Marsden NHS Trust
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London, Reino Unido, SW10 9NH
- Chelsea And Westminster Hospital
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Manchester, Reino Unido, M20 4BX
- Christie NHS Foundation Trust
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Nottingham, Reino Unido, NG5 1PB
- Nottingham University Hospitals NHS Trust
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Sutton, Reino Unido, SM2 5PT
- The Royal Marsden NHS Trust 1
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Irkutsk, Rússia, 664035
- Irkutsk Regional Oncology Dispensary
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Krasnoyarsk, Rússia, 660133
- Krasnoyarsk Regional Oncology Dispensary
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Kuzmolovsky, Rússia, 188663
- Leningrad Regional Oncology Dispensary
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Moscow, Rússia, 115533
- MCK
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Moscow, Rússia, 121205
- Moscow City Oncology Hospital No 62
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Nal'chik, Rússia, 360000
- City Clinical Hospital #1
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Nizhny Novgorod, Rússia, 603000
- Nizhny Novgorod Regional Oncological Dispensary
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Omsk, Rússia, 664013
- Omsk Clinical Oncology Dispensary
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Saint Petersburg, Rússia, 197758
- N.N. Petrov Research Institute Of Oncology
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Saint Petersburg, Rússia, 196006
- Oncology Medical Clinics AV Medical group
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Saint Petersburg, Rússia, 190121
- Current medical technologies
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Tambov, Rússia, 392013
- Tambov Regional Oncology Clinical Dispansary
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Tomsk, Rússia, 634050
- Tomsk Cancer Research Institute
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Ufa, Rússia, 450083
- Bashkir State Medical University
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Yaroslavl, Rússia, 150054
- Yaroslavl Regional Clinical Oncology Hospital
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Bangkok, Tailândia, 10700
- Siriraj Hospital
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Bangkok, Tailândia, 10400
- Phramongkutklao Hospital and Medical College
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Chiang Mai, Tailândia, 50200
- Chiang Mai University
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Songkhla, Tailândia, 90110
- Songklanagarind Hospital, Prince of Songkla University
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Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Kaohsiung City, Taiwan, 833
- Chang Gung Medical Foundation
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Kaohsiung City, Taiwan, 824
- E-DA Hospital
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New Taipei City, Taiwan, 23561
- Taipei Medical University Shuang Ho Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taichung, Taiwan, 402
- Chung Shan Medical University Hospital
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Adana, Turquia (Türkiye), 01060
- Adana City Hospital
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Adana, Turquia (Türkiye), 01250
- Başkent University Medical Faculty Adana Application and Research Center
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Ankara, Turquia (Türkiye), 6800
- Ankara Bilkent City Hospital
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Ankara, Turquia (Türkiye), 06560
- Gazi Hastanesi
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Edirne, Turquia (Türkiye), 22030
- Trakya University Medical Faculty
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Istanbul, Turquia (Türkiye), 34098
- Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
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Istanbul, Turquia (Türkiye), 34722
- T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
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Istanbul, Turquia (Türkiye), 34214
- Medipol Mega University Hospital
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Izmir, Turquia (Türkiye), 35575
- Medical Point
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Konya, Turquia (Türkiye), 42080
- Necmettin Erbakan University Meram Medical Faculty
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Dnipro, Ucrânia, 49102
- Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
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Kharkiv, Ucrânia, 61070
- Municipal non-profit enterprise 'Regional Center of Oncology'
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Kyiv, Ucrânia, 02091
- Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
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Kyiv, Ucrânia, 03022
- State Nonprofit Enterprise National Cancer Institute
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Uzhhorod, Ucrânia, 88000
- Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
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Hyderabad, Índia, 500034
- Basavatarakam Indo-American Hospital
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Kolkata, Índia, 700160
- Tata Medical Center
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Mumbai, Índia, 400012
- Tata Memorial Hospital
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Nashik, Índia, 422002
- HCG Manavta Cancer Centre
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Pune, Índia, 411013
- Noble Hospital Pvt Ltd
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
Outros nomes:
Participants will receive lazertinib tablets orally.
Outros nomes:
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Comparador Ativo: 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. |
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Experimental: 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.
Outros nomes:
Participants will receive matching placebo orally. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: 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)
|
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Objective Response Rate (ORR)
Prazo: 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
|
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Duration of Response (DOR)
Prazo: 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)
Prazo: 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
|
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Time to Symptomatic Progression (TTSP)
Prazo: 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
|
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Intracranial PFS
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
|
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Number of Participants With Physical Examination Abnormalities
Prazo: Approximately 60 months
|
Number of participants with physical examination abnormalities will be reported. |
Approximately 60 months
|
|
Serum Concentration of Amivantamab
Prazo: Approximately 60 months
|
Serum samples will be analyzed to determine concentrations of Amivantamab. |
Approximately 60 months
|
|
Plasma Concentration of Lazertinib
Prazo: Approximately 60 months
|
Plasma samples will be analyzed to determine concentrations of Lazertinib. |
Approximately 60 months
|
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Number of Participants With Anti-Amivantamab Antibodies
Prazo: Approximately 60 months
|
Number of participants with antibodies to amivantamab will be reported. |
Approximately 60 months
|
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Change From Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ)
Prazo: 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
|
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Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
30 de setembro de 2020
Conclusão Primária (Real)
11 de agosto de 2023
Conclusão do estudo (Estimado)
16 de fevereiro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
23 de julho de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de julho de 2020
Primeira postagem (Real)
27 de julho de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de novembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de novembro de 2026
Última verificação
1 de novembro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CR108856
- 2020-000743-31 (Número EudraCT)
- 73841937NSC3003 (Outro identificador: Janssen Research & Development, LLC)
- 2023-506576-27-00 (Identificador de registro: EUCT number)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .