Badanie terapii skojarzonej amiwantamabem i lazertynibem w porównaniu z ozymertynibem w miejscowo zaawansowanym lub przerzutowym niedrobnokomórkowym raku płuca (MARIPOSA)
2 listopada 2026 zaktualizowane przez: Janssen Research & Development, LLC
Randomizowane badanie III fazy porównujące terapię skojarzoną amiwantamabem i lazertynibem w porównaniu z ozymertynibem w porównaniu z lazertynibem jako leczenie pierwszego rzutu u pacjentów z miejscowo zaawansowanym lub przerzutowym niedrobnokomórkowym rakiem płuca z mutacją 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).
Przegląd badań
Status
Aktywny, nie rekrutujący
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1074
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Buenos Aires, Argentyna, C1428ANZ
- Instituto Alexander Fleming
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Buenos Aires, Argentyna, C1426AGE
- Centro Oncológico Korben
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Córdoba, Argentyna, X5016KEH
- Hospital Privado Centro Medico de Cordoba
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La Rioja, Argentyna, F5300COE
- Centro Oncologico Riojano Integral (Cori)
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Viedma, Argentyna, R8500ACE
- Clínica Viedma
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Bedford Park, Australia, 5042
- Flinders Medical Centre
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Heidelberg, Australia, 3084
- Austin Hospital
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Malvern, Australia, 3144
- Cabrini Medical Centre
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Murdoch, Australia, 6150
- St John of God Hospital Murdoch
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Nedlands, Australia, 6009
- Sir Charles Gairdner Hospital
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Westmead, Australia, 2145
- Westmead Hospital
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Wollongong, Australia, 2500
- Southern Medical Day Care Centre
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Woolloongabba, Australia, 4102
- Princess Alexandra Hospital
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Brussels, Belgia, 1200
- Cliniques Universitaires Saint Luc
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Charleroi, Belgia, 6060
- Grand Hopital De Charleroi Site Les Viviers
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Leuven, Belgia, 3000
- UZ Leuven
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Ottignies, Belgia, 1340
- Clinique Saint Pierre
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Roeselare, Belgia, 8800
- Algemeen Ziekenhuis Delta
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Barretos, Brazylia, 14784-400
- Fundacao Pio XII
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Belo Horizonte, Brazylia, 30110-022
- Cetus Oncologia
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Florianópolis, Brazylia, 88020-210
- Ynova Pesquisa Clinica
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Ijuí, Brazylia, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Natal, Brazylia, 59062 000
- Liga Norte Riograndense Contra O Cancer
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Pelotas, Brazylia, 96020 080
- UPCO Unidade de Pesquisa Clinica em Oncologia
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Porto Alegre, Brazylia, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto Alegre, Brazylia, 90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Rio de Janeiro, Brazylia, 22 250 905
- Oncoclinicas Rio de Janeiro S A
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Rio de Janeiro, Brazylia, 20231 050
- Ministerio da Saude Instituto Nacional do Cancer
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Rio de Janeiro, Brazylia, 22281 100
- IDOR - Regional Rio de Janeiro
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Sorocaba, Brazylia, 18030-075
- IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
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São Paulo, Brazylia, 04014-002
- Núcleo de Pesquisa São Camilo
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São Paulo, Brazylia, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
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São Paulo, Brazylia, 01246 000
- Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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Vitória, Brazylia, 29308-014
- Hospital Evangélico de Cachoeiro de Itapemirim
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Beijing, Chiny, 100853
- Chinese PLA General Hospital
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Beijing, Chiny, 100050
- Beijing Friendship Hospital Capital Medical University
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Beijing, Chiny, 100142
- Beijing Cancer Hospital Respiratory Medicine Department II
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Beijing, Chiny, 100142
- Beijing Cancer Hospital Respiratory Medicine Department I
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Beijing, Chiny, 101149
- Beijing Chest hospital, Capital medical university
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Changchun, Chiny, 130000
- Jilin cancer hospital
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Changsha, Chiny, 410013
- Hunan Cancer hospital Thoracic Medicine Department II
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Changsha, Chiny, 410013
- Hunan Cancer hospital Thoracic Medicine Department I
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Changzhou, Chiny, 213003
- The First People's Hospital Of Changzhou
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Chengdu, Chiny, 610041
- Sichuan Cancer Hospital
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Chengdu, Chiny, 610041
- West China Hospital Sichuan University
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Chongqing, Chiny, 400038
- Southwest Hospital
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Guangzhou, Chiny, 510080
- The First Affiliated Hospital Sun Yat sen University
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Guangzhou, Chiny, 510120
- Sun Yat-Sen Memorial Hospital Sun Yat-sen University
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Hangzhou, Chiny, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Chiny, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Hangzhou, Chiny, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Hangzhou, Chiny, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Harbin, Chiny, 150000
- Harbin medical university cancer hospital
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Huizhou, Chiny, 516001
- Huizhou Municipal Central Hospital
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Linhai, Chiny, 317000
- Taizhou Hospital of Zhejiang Province
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Nantong, Chiny, 226300
- Nantong Tumor Hospital
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Shanghai, Chiny, 200030
- Shanghai Chest Hospital
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Shanghai, Chiny, 200032
- Fudan University Shanghai Cancer Center
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Shanghai, Chiny, 200123
- Shanghai East Hospital
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Shanghai, Chiny, 200025
- Ruijin Hospital Shanghai Jiao Tong University
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Shenyang, Chiny, 110004
- Shengjing Hospital Of China Medical University
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Tianjin, Chiny, 300052
- Tianjin Medical University General Hospital
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Wenzhou, Chiny, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Chiny, 430030
- TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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Xi'an, Chiny, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Yantai, Chiny, 264000
- Yantai Yuhuangding Hospital
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Zhengzhou, Chiny, 450008
- Henan Cancer Hospital
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Ürümqi, Chiny, 830000
- Cancer Hospital of Xinjiang Medical University
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Bordeaux, Francja, 33000
- Institut Bergonie
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Bron, Francja, 69500
- Hospices Civils de Lyon HCL
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La Tronche, Francja, 38700
- CHU de Grenoble Hopital Albert Michallon
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Lille, Francja, 59000
- Institute Coeur Poumon
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Limoges, Francja, 87000
- CHU de Limoges
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Marseille, Francja, 13915
- Hopital Nord
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Paris, Francja, 75005
- Institut Curie
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Paris, Francja, 75970
- Hopital Tenon
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Pessac, Francja, 33604
- CHU Bordeaux
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Sain-Herblain, Francja, 44800
- CHU Nantes
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Saint-Mandé, Francja, 94163
- HIA Begin
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Tours, Francja, 37000
- CHU Bretonneau
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Villejuif, Francja, 94805
- Institut Gustave Roussy
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A Coruña, Hiszpania, 15006
- Hosp Univ A Coruna
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Badalona, Hiszpania, 08916
- Inst. Cat. D'Oncologia-Badalona
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Barcelona, Hiszpania, 08025
- Hosp. de La Santa Creu I Sant Pau
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Barcelona, Hiszpania, 08028
- Hosp. Univ. Quiron Dexeus
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Barcelona, Hiszpania, 08035
- Hosp Univ Vall D Hebron
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Burgos, Hiszpania, 09003
- Hosp. Univ. de Burgos
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Girona, Hiszpania, 17007
- Institut Català D'Oncologia Girona
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Madrid, Hiszpania, 28041
- Hosp. Univ. 12 de Octubre
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Madrid, Hiszpania, 28046
- Hosp. Univ. La Paz
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Madrid, Hiszpania, 28007
- Hosp. Gral. Univ. Gregorio Maranon
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Majadahonda, Hiszpania, 28222
- Hosp. Univ. Pta. de Hierro Majadahonda
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Málaga, Hiszpania, 29011
- Hosp Regional Univ de Malaga
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Pamplona, Hiszpania, 31008
- Clinica Univ. de Navarra
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Seville, Hiszpania, 41013
- Hosp. Virgen Del Rocio
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Valencia, Hiszpania, 46014
- Hosp. Gral. Univ. Valencia
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Zaragoza, Hiszpania, 50009
- Hosp. Clinico Univ. Lozano Blesa
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's-Hertogenbosch, Holandia, 5223 GZ
- Jeroen Bosch Ziekenhuis
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Arnhem, Holandia, 6815 AD
- Rijnstate Ziekenhuis
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Harderwijk, Holandia, 3844 DG
- Ziekenhuis St Jansdal
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Nijmegen, Holandia, 6525AG
- UMC Radboud
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Hyderabad, Indie, 500034
- Basavatarakam Indo-American Hospital
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Kolkata, Indie, 700160
- Tata Medical Center
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Mumbai, Indie, 400012
- Tata Memorial Hospital
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Nashik, Indie, 422002
- HCG Manavta Cancer Centre
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Pune, Indie, 411013
- Noble Hospital Pvt Ltd
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Haifa, Izrael, 3109601
- Rambam Health Corporation
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Jerusalem, Izrael, 9112001
- Hadassah Medical Center
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Kfar Saba, Izrael, 44281
- Meir Medical Center
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Petah Tikva, Izrael, 49100
- Rabin Medical Center
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Ramat Gan, Izrael, 5262100
- Chaim Sheba Medical Center
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Tel Aviv, Izrael, 6423906
- Tel Aviv Sourasky Medical Center
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Bunkyō City, Japonia, 113 8431
- Juntendo University Hospital
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Chūōku, Japonia, 104 0045
- National Cancer Center Hospital
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Fukuoka, Japonia, 810-8563
- National Hospital Organization Kyushu Medical Center
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Himeji, Japonia, 670-8520
- National Hospital Organization Himeji Medical Center
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Hirakata, Japonia, 573 1191
- Kansai Medical University Hospital
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Kanazawa, Japonia, 920 8641
- Kanazawa University Hospital
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Kashiwa, Japonia, 277 8577
- National Cancer Center Hospital East
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Kurume, Japonia, 830-0011
- Kurume University Hospital
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Matsusaka, Japonia, 515-8544
- Matsusaka Municipal Hospital
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Niigata, Japonia, 951-8566
- Niigata Cancer Center Hospital
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Okayama, Japonia, 700 8558
- Okayama University Hospital
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Osaka Sayama Shi, Japonia, 589 8511
- Kindai University Hospital
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Shibukawa, Japonia, 377-0280
- National Hospital Organization Shibukawa Medical Center
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Tokyo, Japonia, 135 8550
- The Cancer Institute Hospital of JFCR
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Tokyo, Japonia, 152 8902
- National Hospital Organization Tokyo Medical Center
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Toon-shi, Japonia, 791-0295
- Ehime University Hospital
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Toyonaka-shi, Japonia, 560-8552
- National Hospital Organization Osaka Toneyama Medical Center
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Wakayama, Japonia, 641 8510
- Wakayama Medical University Hospital
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Yamaguchi, Japonia, 740-8510
- National Hospital Organization Iwakuni Clinical Center
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Yamaguchi, Japonia, 755-0241
- National Hospital Organization Yamaguchi Ube Medical Center
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Ontario
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Brampton, Ontario, Kanada, L6R 3J7
- William Osler Health System
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Hamilton, Ontario, Kanada, L8V 5C2
- Juravinski Cancer Centre
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Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital Cancer Centre
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Quebec
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Montreal, Quebec, Kanada, H4A 3J1
- McGill University Health Centre
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Busan, Korea Południowa, 48108
- Inje University Haeundae Paik Hospital
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Cheongju-si, Korea Południowa, 28644
- Chungbuk National University Hospital
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Seongnam-si, Korea Południowa, 13620
- Seoul National University Bundang Hospital
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Seoul, Korea Południowa, 05505
- Asan Medical Center
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Seoul, Korea Południowa, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Korea Południowa, 06351
- Samsung Medical Center
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Seoul, Korea Południowa, 03181
- Kangbuk Samsung Hospital
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Seoul, Korea Południowa, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
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Seoul, Korea Południowa, 8308
- Korea University Guro Hospital
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George Town, Malezja, 10990
- Hospital Pulau Pinang
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Johor Bahru, Malezja, 81100
- Hospital Sultan Ismail
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Kuala Lumpur, Malezja, 50586
- Hospital Kuala Lumpur
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Kuala Lumpur, Malezja, 59100
- University Malaya Medical Centre
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Kuantan, Malezja, 25100
- Hospital Tengku Ampuan Afzan
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Petaling Jaya, Malezja, 46050
- Beacon Hospital Sdn Bhd
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Guadalajara, Meksyk, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
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León, Meksyk, 37000
- CIMOVA, Morals Vargas Centro de Investigación SC
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Mexico City, Meksyk, 14050
- Médica Sur
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Mexico City, Meksyk, 03100
- Mexico Centre for Clinical Research, S.A. de C.V.
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Monterrey, Meksyk, 64710
- i Can Oncology Center
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México, Meksyk, 14080
- Instituto Nacional de Cancerologia
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México, Meksyk, 03100
- Health Pharma Professional Research
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Naucalpan, Meksyk, 53100
- Oncologia Integral Satelite
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Bad Berka, Niemcy, 99437
- Zentralklinik Bad Berka GmbH
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Berlin, Niemcy, 14165
- Helios Klinikum Emil von Behring GmbH
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Cologne, Niemcy, 51109
- Kliniken der Stadt Koeln gGmbH
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Essen, Niemcy, 45147
- Universitaetsklinikum Essen
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Gauting, Niemcy, 82131
- Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
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Halle, Niemcy, 06120
- Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
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Heidelberg, Niemcy, 69126
- Thoraxklinik am Universitatsklinikum Heidelberg
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Heilbronn, Niemcy, 74072
- Onkologische Schwerpunktpraxis
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Leipzig, Niemcy, 04357
- POIS Leipzig GbR
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Oldenburg, Niemcy, 26121
- Pius-Hospital Oldenburg
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Stuttgart, Niemcy, 70376
- Robert-Bosch-Krankenhaus - Klinik Schillerhoehe
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Bydgoszcz, Polska, 85 796
- Centrum Onkologii im Prof F Lukaszczyka
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Gdansk, Polska, 80 214
- Uniwersyteckie Centrum Kliniczne
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Gdynia, Polska, 81 519
- Szpitale Pomorskie Sp z o o
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Olsztyn, Polska, 10-357
- Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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Poznan, Polska, 60-693
- Private Specialist Hospitals - MedPolonia
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Warsaw, Polska, 02-781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Rio Piedras, Portoryko, 00935
- Pan American Center for Oncology Trials LLC
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Lisbon, Portugalia, 1769-001
- Uls Santa Maria - Hosp. Pulido Valente
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Porto, Portugalia, 4200-072
- Instituto Portugues de Oncologia
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Porto, Portugalia, 4099-001
- Uls Santo Antonio - Hosp. Santo Antonio
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Porto, Portugalia, 4100 180
- Hosp. Cuf Porto
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Irkutsk, Rosja, 664035
- Irkutsk Regional Oncology Dispensary
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Krasnoyarsk, Rosja, 660133
- Krasnoyarsk Regional Oncology Dispensary
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Kuzmolovsky, Rosja, 188663
- Leningrad Regional Oncology Dispensary
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Moscow, Rosja, 115533
- MCK
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Moscow, Rosja, 121205
- Moscow City Oncology Hospital No 62
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Nal'chik, Rosja, 360000
- City Clinical Hospital #1
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Nizhny Novgorod, Rosja, 603000
- Nizhny Novgorod Regional Oncological Dispensary
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Omsk, Rosja, 664013
- Omsk Clinical Oncology Dispensary
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Saint Petersburg, Rosja, 197758
- N.N. Petrov Research Institute Of Oncology
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Saint Petersburg, Rosja, 196006
- Oncology Medical Clinics AV Medical group
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Saint Petersburg, Rosja, 190121
- Current medical technologies
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Tambov, Rosja, 392013
- Tambov Regional Oncology Clinical Dispansary
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Tomsk, Rosja, 634050
- Tomsk Cancer Research Institute
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Ufa, Rosja, 450083
- Bashkir State Medical University
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Yaroslavl, Rosja, 150054
- Yaroslavl Regional Clinical Oncology Hospital
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Arizona
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Goodyear, Arizona, Stany Zjednoczone, 85395
- Arizona Oncology Associates, PC - HAL
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Yuma, Arizona, Stany Zjednoczone, 85364
- Yuma Regional Medical Center
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California
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Long Beach, California, Stany Zjednoczone, 90813
- City of Hope Long Beach Elm
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Orange, California, Stany Zjednoczone, 92868
- University of California Irvine
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Colorado
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Rocky Mountain Cancer Centers
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Florida
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Jacksonville, Florida, Stany Zjednoczone, 32256
- Cancer Specialists of North Florida
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Georgia
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Athens, Georgia, Stany Zjednoczone, 30607
- University Cancer And Blood Center LLC
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Louisiana
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Metairie, Louisiana, Stany Zjednoczone, 70006
- East Jefferson General Hospital
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Maryland
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Columbia, Maryland, Stany Zjednoczone, 21044
- Maryland Oncology Hematology, PA
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48202
- Henry Ford Hospital
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Minnesota
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Edina, Minnesota, Stany Zjednoczone, 55435
- Minnesota Oncology Hematology P A
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Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic
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Missouri
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St Louis, Missouri, Stany Zjednoczone, 63110
- Washington University School Of Medicine
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New Jersey
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East Brunswick, New Jersey, Stany Zjednoczone, 08816
- Astera Cancer Care
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Oregon
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Eugene, Oregon, Stany Zjednoczone, 97401
- Willamette Valley Cancer Institute and Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15232
- University of Pittsburgh Medical Center
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37203
- Sarah Cannon Research Institute
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Texas
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Austin, Texas, Stany Zjednoczone, 78745
- Texas Oncology P A
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Houston, Texas, Stany Zjednoczone, 77030
- Oncology Consultants Texas
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Virginia
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Fairfax, Virginia, Stany Zjednoczone, 22031
- Virginia Cancer Specialists
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Bangkok, Tajlandia, 10700
- Siriraj Hospital
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Bangkok, Tajlandia, 10400
- Phramongkutklao Hospital and Medical College
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Chiang Mai, Tajlandia, 50200
- Chiang Mai University
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Songkhla, Tajlandia, 90110
- Songklanagarind Hospital, Prince of Songkla University
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Kaohsiung City, Tajwan, 807
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Kaohsiung City, Tajwan, 833
- Chang Gung Medical Foundation
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Kaohsiung City, Tajwan, 824
- E-DA Hospital
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New Taipei City, Tajwan, 23561
- Taipei Medical University Shuang Ho Hospital
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Taichung, Tajwan, 40447
- China Medical University Hospital
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Taichung, Tajwan, 402
- Chung Shan Medical University Hospital
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Tainan, Tajwan, 704
- National Cheng Kung University Hospital
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Taipei, Tajwan, 10002
- National Taiwan University Hospital
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Adana, Turcja (Türkiye), 01060
- Adana City Hospital
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Adana, Turcja (Türkiye), 01250
- Başkent University Medical Faculty Adana Application and Research Center
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Ankara, Turcja (Türkiye), 6800
- Ankara Bilkent City Hospital
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Ankara, Turcja (Türkiye), 06560
- Gazi Hastanesi
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Edirne, Turcja (Türkiye), 22030
- Trakya University Medical Faculty
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Istanbul, Turcja (Türkiye), 34098
- Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
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Istanbul, Turcja (Türkiye), 34722
- T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
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Istanbul, Turcja (Türkiye), 34214
- Medipol Mega University Hospital
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Izmir, Turcja (Türkiye), 35575
- Medical Point
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Konya, Turcja (Türkiye), 42080
- Necmettin Erbakan University Meram Medical Faculty
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Dnipro, Ukraina, 49102
- Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
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Kharkiv, Ukraina, 61070
- Municipal non-profit enterprise 'Regional Center of Oncology'
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Kyiv, Ukraina, 02091
- Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
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Kyiv, Ukraina, 03022
- State Nonprofit Enterprise National Cancer Institute
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Uzhhorod, Ukraina, 88000
- Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
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Budapest, Węgry, H-1529
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
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Farkasgyepü, Węgry, 8582
- Veszprém Megyei Tudőgyógyintézet
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Gyöngyös, Węgry, 3233
- Mátrai Gyógyintézet-Bronchológia
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Szombathely, Węgry, 9700
- Markusovszky Egyetemi Oktatokorhaz
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Székesfehérvár, Węgry, 8000
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
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Törökbálint, Węgry, 2045
- Tudogyogyintezet Torokbalint
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Avellino, Włochy, 83100
- Ospedale San Giuseppe Moscati di Avellino
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Catania, Włochy, 95123
- Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
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Meldola, Włochy, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Włochy, 20141
- Istituto Europeo di Oncologia
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Milan, Włochy, 20132
- IRCCS Ospedale San Raffaele
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Milan, Włochy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Włochy, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Monza, Włochy, 20052
- San Gerardo Hospital
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Naples, Włochy, 80100
- Ospedale Monaldi
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Orbassano, Włochy, 10043
- Aou San Luigi Gonzaga
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Ravenna, Włochy, 48121
- Ospedale S. Maria Delle Croci
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Roma, Włochy, 00168
- Irccs Gemelli
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Rozzano, Włochy, 20089
- Istituto Clinico Humanitas
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Edinburgh, Zjednoczone Królestwo, EH4 2XU
- Edinburgh Cancer Centre Western General
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London, Zjednoczone Królestwo, NW1 2PG
- UCL Cancer Institute
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London, Zjednoczone Królestwo, SW3 6JJ
- The Royal Marsden NHS Trust
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London, Zjednoczone Królestwo, SW10 9NH
- Chelsea And Westminster Hospital
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Manchester, Zjednoczone Królestwo, M20 4BX
- Christie NHS Foundation Trust
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Nottingham, Zjednoczone Królestwo, NG5 1PB
- Nottingham University Hospitals NHS Trust
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Sutton, Zjednoczone Królestwo, SM2 5PT
- The Royal Marsden NHS Trust 1
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
Inne nazwy:
Participants will receive lazertinib tablets orally.
Inne nazwy:
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Aktywny komparator: 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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Eksperymentalny: 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.
Inne nazwy:
Participants will receive matching placebo orally. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Ramy czasowe: From randomization to either disease progression or death whichever occurs first (up to 32.8 months)
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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)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Overall Survival (OS)
Ramy czasowe: Approximately 60 months (time from the date of randomization until the date of death due to any cause)
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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)
Ramy czasowe: Approximately 32.8 months
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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)
Ramy czasowe: Approximately 32.8 months
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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
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Progression-Free Survival After First Subsequent Therapy (PFS2)
Ramy czasowe: Approximately 60 months
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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)
Ramy czasowe: Approximately 60 months
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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
Ramy czasowe: Approximately 60 months
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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
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Incidence and Severity of Adverse Events (AEs)
Ramy czasowe: Approximately 60 months
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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
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Number of Participants With Clinical Laboratory Abnormalities
Ramy czasowe: Approximately 60 months
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Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported. |
Approximately 60 months
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Number of Participants With Vital Signs Abnormalities
Ramy czasowe: Approximately 60 months
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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
Ramy czasowe: Approximately 60 months
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Number of participants with physical examination abnormalities will be reported. |
Approximately 60 months
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Serum Concentration of Amivantamab
Ramy czasowe: Approximately 60 months
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Serum samples will be analyzed to determine concentrations of Amivantamab. |
Approximately 60 months
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Plasma Concentration of Lazertinib
Ramy czasowe: Approximately 60 months
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Plasma samples will be analyzed to determine concentrations of Lazertinib. |
Approximately 60 months
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Number of Participants With Anti-Amivantamab Antibodies
Ramy czasowe: Approximately 60 months
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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)
Ramy czasowe: Baseline up to approximately 60 months
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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)
Ramy czasowe: Baseline up to approximately 60 months
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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
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
30 września 2020
Zakończenie podstawowe (Rzeczywisty)
11 sierpnia 2023
Ukończenie studiów (Szacowany)
16 lutego 2028
Daty rejestracji na studia
Pierwszy przesłany
23 lipca 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 lipca 2020
Pierwszy wysłany (Rzeczywisty)
27 lipca 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 listopada 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
2 listopada 2026
Ostatnia weryfikacja
1 listopada 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CR108856
- 2020-000743-31 (Numer EudraCT)
- 73841937NSC3003 (Inny identyfikator: Janssen Research & Development, LLC)
- 2023-506576-27-00 (Identyfikator rejestru: EUCT number)
- 2023 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .