Studie kombinované terapie amivantamabem a lazertinibem versus osimertinib u lokálně pokročilého nebo metastatického nemalobuněčného karcinomu plic (MARIPOSA)
2. listopadu 2026 aktualizováno: Janssen Research & Development, LLC
Randomizovaná studie fáze 3 kombinované terapie amivantamabem a lazertinibem versus osimertinib versus lazertinib jako léčba první linie u pacientů s EGFR-mutovaným lokálně pokročilým nebo metastatickým nemalobuněčným karcinomem plic.
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).
Přehled studie
Postavení
Aktivní, ne nábor
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
1074
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Buenos Aires, Argentina, C1428ANZ
- Instituto Alexander Fleming
-
Buenos Aires, Argentina, C1426AGE
- Centro Oncológico Korben
-
Córdoba, Argentina, X5016KEH
- Hospital Privado Centro Medico de Cordoba
-
La Rioja, Argentina, F5300COE
- Centro Oncologico Riojano Integral (Cori)
-
Viedma, Argentina, R8500ACE
- Clínica Viedma
-
-
-
-
-
Bedford Park, Austrálie, 5042
- Flinders Medical Centre
-
Heidelberg, Austrálie, 3084
- Austin Hospital
-
Malvern, Austrálie, 3144
- Cabrini Medical Centre
-
Murdoch, Austrálie, 6150
- St John of God Hospital Murdoch
-
Nedlands, Austrálie, 6009
- Sir Charles Gairdner Hospital
-
Westmead, Austrálie, 2145
- Westmead Hospital
-
Wollongong, Austrálie, 2500
- Southern Medical Day Care Centre
-
Woolloongabba, Austrálie, 4102
- Princess Alexandra Hospital
-
-
-
-
-
Brussels, Belgie, 1200
- Cliniques Universitaires Saint Luc
-
Charleroi, Belgie, 6060
- Grand Hopital De Charleroi Site Les Viviers
-
Leuven, Belgie, 3000
- UZ Leuven
-
Ottignies, Belgie, 1340
- Clinique Saint Pierre
-
Roeselare, Belgie, 8800
- Algemeen Ziekenhuis Delta
-
-
-
-
-
Barretos, Brazílie, 14784-400
- Fundacao Pio XII
-
Belo Horizonte, Brazílie, 30110-022
- Cetus Oncologia
-
Florianópolis, Brazílie, 88020-210
- Ynova Pesquisa Clinica
-
Ijuí, Brazílie, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
-
Natal, Brazílie, 59062 000
- Liga Norte Riograndense Contra O Cancer
-
Pelotas, Brazílie, 96020 080
- UPCO Unidade de Pesquisa Clinica em Oncologia
-
Porto Alegre, Brazílie, 90020-090
- Irmandade Santa Casa de Misericordia de Porto Alegre
-
Porto Alegre, Brazílie, 90610-000
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
-
Rio de Janeiro, Brazílie, 22 250 905
- Oncoclinicas Rio de Janeiro S A
-
Rio de Janeiro, Brazílie, 20231 050
- Ministerio da Saude Instituto Nacional do Cancer
-
Rio de Janeiro, Brazílie, 22281 100
- IDOR - Regional Rio de Janeiro
-
Sorocaba, Brazílie, 18030-075
- IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
-
São Paulo, Brazílie, 04014-002
- Núcleo de Pesquisa São Camilo
-
São Paulo, Brazílie, 01509 900
- Fundacao Antonio Prudente A C Camargo Cancer Center
-
São Paulo, Brazílie, 01246 000
- Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
-
Vitória, Brazílie, 29308-014
- Hospital Evangélico de Cachoeiro de Itapemirim
-
-
-
-
-
Bordeaux, Francie, 33000
- Institut Bergonie
-
Bron, Francie, 69500
- Hospices Civils de Lyon HCL
-
La Tronche, Francie, 38700
- CHU de Grenoble Hopital Albert Michallon
-
Lille, Francie, 59000
- Institute Coeur Poumon
-
Limoges, Francie, 87000
- CHU de Limoges
-
Marseille, Francie, 13915
- Hopital Nord
-
Paris, Francie, 75005
- Institut Curie
-
Paris, Francie, 75970
- Hopital Tenon
-
Pessac, Francie, 33604
- CHU Bordeaux
-
Sain-Herblain, Francie, 44800
- CHU Nantes
-
Saint-Mandé, Francie, 94163
- HIA Begin
-
Tours, Francie, 37000
- CHU Bretonneau
-
Villejuif, Francie, 94805
- Institut Gustave Roussy
-
-
-
-
-
's-Hertogenbosch, Holandsko, 5223 GZ
- Jeroen Bosch Ziekenhuis
-
Arnhem, Holandsko, 6815 AD
- Rijnstate Ziekenhuis
-
Harderwijk, Holandsko, 3844 DG
- Ziekenhuis St Jansdal
-
Nijmegen, Holandsko, 6525AG
- UMC Radboud
-
-
-
-
-
Hyderabad, Indie, 500034
- Basavatarakam Indo-American Hospital
-
Kolkata, Indie, 700160
- Tata Medical Center
-
Mumbai, Indie, 400012
- Tata Memorial Hospital
-
Nashik, Indie, 422002
- HCG Manavta Cancer Centre
-
Pune, Indie, 411013
- Noble Hospital Pvt Ltd
-
-
-
-
-
Avellino, Itálie, 83100
- Ospedale San Giuseppe Moscati di Avellino
-
Catania, Itálie, 95123
- Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
-
Meldola, Itálie, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
-
Milan, Itálie, 20141
- Istituto Europeo di Oncologia
-
Milan, Itálie, 20132
- IRCCS Ospedale San Raffaele
-
Milan, Itálie, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
-
Milan, Itálie, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
-
Monza, Itálie, 20052
- San Gerardo Hospital
-
Naples, Itálie, 80100
- Ospedale Monaldi
-
Orbassano, Itálie, 10043
- Aou San Luigi Gonzaga
-
Ravenna, Itálie, 48121
- Ospedale S. Maria Delle Croci
-
Roma, Itálie, 00168
- Irccs Gemelli
-
Rozzano, Itálie, 20089
- Istituto Clinico Humanitas
-
-
-
-
-
Haifa, Izrael, 3109601
- Rambam Health Corporation
-
Jerusalem, Izrael, 9112001
- Hadassah Medical Center
-
Kfar Saba, Izrael, 44281
- Meir Medical Center
-
Petah Tikva, Izrael, 49100
- Rabin Medical Center
-
Ramat Gan, Izrael, 5262100
- Chaim Sheba Medical Center
-
Tel Aviv, Izrael, 6423906
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Bunkyō City, Japonsko, 113 8431
- Juntendo University Hospital
-
Chūōku, Japonsko, 104 0045
- National Cancer Center Hospital
-
Fukuoka, Japonsko, 810-8563
- National Hospital Organization Kyushu Medical Center
-
Himeji, Japonsko, 670-8520
- National Hospital Organization Himeji Medical Center
-
Hirakata, Japonsko, 573 1191
- Kansai Medical University Hospital
-
Kanazawa, Japonsko, 920 8641
- Kanazawa University Hospital
-
Kashiwa, Japonsko, 277 8577
- National Cancer Center Hospital East
-
Kurume, Japonsko, 830-0011
- Kurume University Hospital
-
Matsusaka, Japonsko, 515-8544
- Matsusaka Municipal Hospital
-
Niigata, Japonsko, 951-8566
- Niigata Cancer Center Hospital
-
Okayama, Japonsko, 700 8558
- Okayama University Hospital
-
Osaka Sayama Shi, Japonsko, 589 8511
- Kindai University Hospital
-
Shibukawa, Japonsko, 377-0280
- National Hospital Organization Shibukawa Medical Center
-
Tokyo, Japonsko, 135 8550
- The Cancer Institute Hospital of JFCR
-
Tokyo, Japonsko, 152 8902
- National Hospital Organization Tokyo Medical Center
-
Toon-shi, Japonsko, 791-0295
- Ehime University Hospital
-
Toyonaka-shi, Japonsko, 560-8552
- National Hospital Organization Osaka Toneyama Medical Center
-
Wakayama, Japonsko, 641 8510
- Wakayama Medical University Hospital
-
Yamaguchi, Japonsko, 740-8510
- National Hospital Organization Iwakuni Clinical Center
-
Yamaguchi, Japonsko, 755-0241
- National Hospital Organization Yamaguchi Ube Medical Center
-
-
-
-
-
Busan, Jižní Korea, 48108
- Inje University Haeundae Paik Hospital
-
Cheongju-si, Jižní Korea, 28644
- Chungbuk National University Hospital
-
Seongnam-si, Jižní Korea, 13620
- Seoul National University Bundang Hospital
-
Seoul, Jižní Korea, 05505
- Asan Medical Center
-
Seoul, Jižní Korea, 03722
- Severance Hospital Yonsei University Health System
-
Seoul, Jižní Korea, 06351
- Samsung Medical Center
-
Seoul, Jižní Korea, 03181
- Kangbuk Samsung Hospital
-
Seoul, Jižní Korea, 06591
- The Catholic University of Korea Seoul St Mary s Hospital
-
Seoul, Jižní Korea, 8308
- Korea University Guro Hospital
-
-
-
-
Ontario
-
Brampton, Ontario, Kanada, L6R 3J7
- William Osler Health System
-
Hamilton, Ontario, Kanada, L8V 5C2
- Juravinski Cancer Centre
-
Ottawa, Ontario, Kanada, K1H 8L6
- The Ottawa Hospital Cancer Centre
-
-
Quebec
-
Montreal, Quebec, Kanada, H4A 3J1
- McGill University Health Centre
-
-
-
-
-
George Town, Malajsie, 10990
- Hospital Pulau Pinang
-
Johor Bahru, Malajsie, 81100
- Hospital Sultan Ismail
-
Kuala Lumpur, Malajsie, 50586
- Hospital Kuala Lumpur
-
Kuala Lumpur, Malajsie, 59100
- University Malaya Medical Centre
-
Kuantan, Malajsie, 25100
- Hospital Tengku Ampuan Afzan
-
Petaling Jaya, Malajsie, 46050
- Beacon Hospital Sdn Bhd
-
-
-
-
-
Budapest, Maďarsko, H-1529
- Orszagos Koranyi Tbc es Pulmonologiai Intezet
-
Farkasgyepü, Maďarsko, 8582
- Veszprém Megyei Tudőgyógyintézet
-
Gyöngyös, Maďarsko, 3233
- Mátrai Gyógyintézet-Bronchológia
-
Szombathely, Maďarsko, 9700
- Markusovszky Egyetemi Oktatokorhaz
-
Székesfehérvár, Maďarsko, 8000
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
-
Törökbálint, Maďarsko, 2045
- Tudogyogyintezet Torokbalint
-
-
-
-
-
Guadalajara, Mexiko, 44280
- Hospital Civil de Guadalajara Fray Antonio Alcalde
-
León, Mexiko, 37000
- CIMOVA, Morals Vargas Centro de Investigación SC
-
Mexico City, Mexiko, 14050
- Médica Sur
-
Mexico City, Mexiko, 03100
- Mexico Centre for Clinical Research, S.A. de C.V.
-
Monterrey, Mexiko, 64710
- i Can Oncology Center
-
México, Mexiko, 14080
- Instituto Nacional de Cancerologia
-
México, Mexiko, 03100
- Health Pharma Professional Research
-
Naucalpan, Mexiko, 53100
- Oncologia Integral Satelite
-
-
-
-
-
Bad Berka, Německo, 99437
- Zentralklinik Bad Berka GmbH
-
Berlin, Německo, 14165
- Helios Klinikum Emil von Behring GmbH
-
Cologne, Německo, 51109
- Kliniken der Stadt Koeln gGmbH
-
Essen, Německo, 45147
- Universitaetsklinikum Essen
-
Gauting, Německo, 82131
- Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
-
Halle, Německo, 06120
- Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
-
Heidelberg, Německo, 69126
- Thoraxklinik am Universitatsklinikum Heidelberg
-
Heilbronn, Německo, 74072
- Onkologische Schwerpunktpraxis
-
Leipzig, Německo, 04357
- POIS Leipzig GbR
-
Oldenburg, Německo, 26121
- Pius-Hospital Oldenburg
-
Stuttgart, Německo, 70376
- Robert-Bosch-Krankenhaus - Klinik Schillerhoehe
-
-
-
-
-
Bydgoszcz, Polsko, 85 796
- Centrum Onkologii im Prof F Lukaszczyka
-
Gdansk, Polsko, 80 214
- Uniwersyteckie Centrum Kliniczne
-
Gdynia, Polsko, 81 519
- Szpitale Pomorskie Sp z o o
-
Olsztyn, Polsko, 10-357
- Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
-
Poznan, Polsko, 60-693
- Private Specialist Hospitals - MedPolonia
-
Warsaw, Polsko, 02-781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
-
-
-
-
-
Rio Piedras, Portoriko, 00935
- Pan American Center for Oncology Trials LLC
-
-
-
-
-
Lisbon, Portugalsko, 1769-001
- Uls Santa Maria - Hosp. Pulido Valente
-
Porto, Portugalsko, 4200-072
- Instituto Portugues de Oncologia
-
Porto, Portugalsko, 4099-001
- Uls Santo Antonio - Hosp. Santo Antonio
-
Porto, Portugalsko, 4100 180
- Hosp. Cuf Porto
-
-
-
-
-
Irkutsk, Rusko, 664035
- Irkutsk Regional Oncology Dispensary
-
Krasnoyarsk, Rusko, 660133
- Krasnoyarsk Regional Oncology Dispensary
-
Kuzmolovsky, Rusko, 188663
- Leningrad Regional Oncology Dispensary
-
Moscow, Rusko, 115533
- MCK
-
Moscow, Rusko, 121205
- Moscow City Oncology Hospital No 62
-
Nal'chik, Rusko, 360000
- City Clinical Hospital #1
-
Nizhny Novgorod, Rusko, 603000
- Nizhny Novgorod Regional Oncological Dispensary
-
Omsk, Rusko, 664013
- Omsk Clinical Oncology Dispensary
-
Saint Petersburg, Rusko, 197758
- N.N. Petrov Research Institute Of Oncology
-
Saint Petersburg, Rusko, 196006
- Oncology Medical Clinics AV Medical group
-
Saint Petersburg, Rusko, 190121
- Current medical technologies
-
Tambov, Rusko, 392013
- Tambov Regional Oncology Clinical Dispansary
-
Tomsk, Rusko, 634050
- Tomsk Cancer Research Institute
-
Ufa, Rusko, 450083
- Bashkir State Medical University
-
Yaroslavl, Rusko, 150054
- Yaroslavl Regional Clinical Oncology Hospital
-
-
-
-
-
Edinburgh, Spojené království, EH4 2XU
- Edinburgh Cancer Centre Western General
-
London, Spojené království, NW1 2PG
- UCL Cancer Institute
-
London, Spojené království, SW3 6JJ
- The Royal Marsden NHS Trust
-
London, Spojené království, SW10 9NH
- Chelsea And Westminster Hospital
-
Manchester, Spojené království, M20 4BX
- Christie NHS Foundation Trust
-
Nottingham, Spojené království, NG5 1PB
- Nottingham University Hospitals NHS Trust
-
Sutton, Spojené království, SM2 5PT
- The Royal Marsden NHS Trust 1
-
-
-
-
Arizona
-
Goodyear, Arizona, Spojené státy, 85395
- Arizona Oncology Associates, PC - HAL
-
Yuma, Arizona, Spojené státy, 85364
- Yuma Regional Medical Center
-
-
California
-
Long Beach, California, Spojené státy, 90813
- City of Hope Long Beach Elm
-
Orange, California, Spojené státy, 92868
- University of California Irvine
-
-
Colorado
-
Lone Tree, Colorado, Spojené státy, 80124
- Rocky Mountain Cancer Centers
-
-
Florida
-
Jacksonville, Florida, Spojené státy, 32256
- Cancer Specialists of North Florida
-
-
Georgia
-
Athens, Georgia, Spojené státy, 30607
- University Cancer And Blood Center LLC
-
-
Louisiana
-
Metairie, Louisiana, Spojené státy, 70006
- East Jefferson General Hospital
-
-
Maryland
-
Columbia, Maryland, Spojené státy, 21044
- Maryland Oncology Hematology, PA
-
-
Michigan
-
Detroit, Michigan, Spojené státy, 48202
- Henry Ford Hospital
-
-
Minnesota
-
Edina, Minnesota, Spojené státy, 55435
- Minnesota Oncology Hematology P A
-
Rochester, Minnesota, Spojené státy, 55905
- Mayo Clinic
-
-
Missouri
-
St Louis, Missouri, Spojené státy, 63110
- Washington University School Of Medicine
-
-
New Jersey
-
East Brunswick, New Jersey, Spojené státy, 08816
- Astera Cancer Care
-
-
Oregon
-
Eugene, Oregon, Spojené státy, 97401
- Willamette Valley Cancer Institute and Research Center
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Spojené státy, 15232
- University of Pittsburgh Medical Center
-
-
Tennessee
-
Nashville, Tennessee, Spojené státy, 37203
- Sarah Cannon Research Institute
-
-
Texas
-
Austin, Texas, Spojené státy, 78745
- Texas Oncology P A
-
Houston, Texas, Spojené státy, 77030
- Oncology Consultants Texas
-
-
Virginia
-
Fairfax, Virginia, Spojené státy, 22031
- Virginia Cancer Specialists
-
-
-
-
-
Kaohsiung City, Tchaj-wan, 807
- Kaohsiung Medical University Chung Ho Memorial Hospital
-
Kaohsiung City, Tchaj-wan, 833
- Chang Gung Medical Foundation
-
Kaohsiung City, Tchaj-wan, 824
- E-DA Hospital
-
New Taipei City, Tchaj-wan, 23561
- Taipei Medical University Shuang Ho Hospital
-
Taichung, Tchaj-wan, 40447
- China Medical University Hospital
-
Taichung, Tchaj-wan, 402
- Chung Shan Medical University Hospital
-
Tainan, Tchaj-wan, 704
- National Cheng Kung University Hospital
-
Taipei, Tchaj-wan, 10002
- National Taiwan University Hospital
-
-
-
-
-
Bangkok, Thajsko, 10700
- Siriraj Hospital
-
Bangkok, Thajsko, 10400
- Phramongkutklao Hospital and Medical College
-
Chiang Mai, Thajsko, 50200
- Chiang Mai University
-
Songkhla, Thajsko, 90110
- Songklanagarind Hospital, Prince of Songkla University
-
-
-
-
-
Adana, Turecko (Türkiye), 01060
- Adana City Hospital
-
Adana, Turecko (Türkiye), 01250
- Başkent University Medical Faculty Adana Application and Research Center
-
Ankara, Turecko (Türkiye), 6800
- Ankara Bilkent City Hospital
-
Ankara, Turecko (Türkiye), 06560
- Gazi Hastanesi
-
Edirne, Turecko (Türkiye), 22030
- Trakya University Medical Faculty
-
Istanbul, Turecko (Türkiye), 34098
- Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
-
Istanbul, Turecko (Türkiye), 34722
- T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
-
Istanbul, Turecko (Türkiye), 34214
- Medipol Mega University Hospital
-
Izmir, Turecko (Türkiye), 35575
- Medical Point
-
Konya, Turecko (Türkiye), 42080
- Necmettin Erbakan University Meram Medical Faculty
-
-
-
-
-
Dnipro, Ukrajina, 49102
- Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
-
Kharkiv, Ukrajina, 61070
- Municipal non-profit enterprise 'Regional Center of Oncology'
-
Kyiv, Ukrajina, 02091
- Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
-
Kyiv, Ukrajina, 03022
- State Nonprofit Enterprise National Cancer Institute
-
Uzhhorod, Ukrajina, 88000
- Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
-
-
-
-
-
Beijing, Čína, 100853
- Chinese PLA General Hospital
-
Beijing, Čína, 100050
- Beijing Friendship Hospital Capital Medical University
-
Beijing, Čína, 100142
- Beijing Cancer Hospital Respiratory Medicine Department II
-
Beijing, Čína, 100142
- Beijing Cancer Hospital Respiratory Medicine Department I
-
Beijing, Čína, 101149
- Beijing Chest hospital, Capital medical university
-
Changchun, Čína, 130000
- Jilin cancer hospital
-
Changsha, Čína, 410013
- Hunan Cancer hospital Thoracic Medicine Department II
-
Changsha, Čína, 410013
- Hunan Cancer hospital Thoracic Medicine Department I
-
Changzhou, Čína, 213003
- The First People's Hospital Of Changzhou
-
Chengdu, Čína, 610041
- Sichuan Cancer Hospital
-
Chengdu, Čína, 610041
- West China Hospital Sichuan University
-
Chongqing, Čína, 400038
- Southwest Hospital
-
Guangzhou, Čína, 510080
- The First Affiliated Hospital Sun Yat sen University
-
Guangzhou, Čína, 510120
- Sun Yat-Sen Memorial Hospital Sun Yat-sen University
-
Hangzhou, Čína, 310022
- Zhejiang Cancer Hospital
-
Hangzhou, Čína, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
Hangzhou, Čína, 310009
- The Second Affiliated Hospital of Zhejiang University College of Medicine
-
Hangzhou, Čína, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
-
Harbin, Čína, 150000
- Harbin medical university cancer hospital
-
Huizhou, Čína, 516001
- Huizhou Municipal Central Hospital
-
Linhai, Čína, 317000
- Taizhou Hospital of Zhejiang Province
-
Nantong, Čína, 226300
- Nantong Tumor Hospital
-
Shanghai, Čína, 200030
- Shanghai Chest Hospital
-
Shanghai, Čína, 200032
- Fudan University Shanghai Cancer Center
-
Shanghai, Čína, 200123
- Shanghai East Hospital
-
Shanghai, Čína, 200025
- Ruijin Hospital Shanghai Jiao Tong University
-
Shenyang, Čína, 110004
- Shengjing Hospital Of China Medical University
-
Tianjin, Čína, 300052
- Tianjin Medical University General Hospital
-
Wenzhou, Čína, 325000
- The First Affiliated Hospital of Wenzhou Medical University
-
Wuhan, Čína, 430030
- TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
-
Xi'an, Čína, 710061
- The First Affiliated Hospital of Xian Jiaotong University
-
Yantai, Čína, 264000
- Yantai Yuhuangding Hospital
-
Zhengzhou, Čína, 450008
- Henan Cancer Hospital
-
Ürümqi, Čína, 830000
- Cancer Hospital of Xinjiang Medical University
-
-
-
-
-
A Coruña, Španělsko, 15006
- Hosp Univ A Coruna
-
Badalona, Španělsko, 08916
- Inst. Cat. D'Oncologia-Badalona
-
Barcelona, Španělsko, 08025
- Hosp. de La Santa Creu I Sant Pau
-
Barcelona, Španělsko, 08028
- Hosp. Univ. Quiron Dexeus
-
Barcelona, Španělsko, 08035
- Hosp Univ Vall D Hebron
-
Burgos, Španělsko, 09003
- Hosp. Univ. de Burgos
-
Girona, Španělsko, 17007
- Institut Català D'Oncologia Girona
-
Madrid, Španělsko, 28041
- Hosp. Univ. 12 de Octubre
-
Madrid, Španělsko, 28046
- Hosp. Univ. La Paz
-
Madrid, Španělsko, 28007
- Hosp. Gral. Univ. Gregorio Maranon
-
Majadahonda, Španělsko, 28222
- Hosp. Univ. Pta. de Hierro Majadahonda
-
Málaga, Španělsko, 29011
- Hosp Regional Univ de Malaga
-
Pamplona, Španělsko, 31008
- Clinica Univ. de Navarra
-
Seville, Španělsko, 41013
- Hosp. Virgen Del Rocio
-
Valencia, Španělsko, 46014
- Hosp. Gral. Univ. Valencia
-
Zaragoza, Španělsko, 50009
- Hosp. Clinico Univ. Lozano Blesa
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
Participants will receive lazertinib tablets orally.
Ostatní jména:
|
|
Aktivní komparátor: 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. |
|
Experimentální: 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.
Ostatní jména:
Participants will receive matching placebo orally. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival (OS)
Časové okno: Approximately 60 months (time from the date of randomization until the date of death due to any cause)
|
Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause. |
Approximately 60 months (time from the date of randomization until the date of death due to any cause)
|
|
Objective Response Rate (ORR)
Časové okno: Approximately 32.8 months
|
ORR is defined as the percentage of participants who achieve either a complete response (CR) or partial response (PR) as defined by BICR using RECIST v1.1 criteria. |
Approximately 32.8 months
|
|
Duration of Response (DOR)
Časové okno: 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)
Časové okno: Approximately 60 months
|
The PFS2 is defined as the time from randomization until the date of second objective disease progression, after initiation of subsequent anticancer therapy, based on investigator assessment (after that used for PFS) or death, whichever comes first. |
Approximately 60 months
|
|
Time to Symptomatic Progression (TTSP)
Časové okno: Approximately 60 months
|
TTSP is defined as the time from randomization to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in anticancer treatment and/or clinical intervention to manage symptoms. |
Approximately 60 months
|
|
Intracranial PFS
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: Approximately 60 months
|
Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported. |
Approximately 60 months
|
|
Number of Participants With Physical Examination Abnormalities
Časové okno: Approximately 60 months
|
Number of participants with physical examination abnormalities will be reported. |
Approximately 60 months
|
|
Serum Concentration of Amivantamab
Časové okno: Approximately 60 months
|
Serum samples will be analyzed to determine concentrations of Amivantamab. |
Approximately 60 months
|
|
Plasma Concentration of Lazertinib
Časové okno: Approximately 60 months
|
Plasma samples will be analyzed to determine concentrations of Lazertinib. |
Approximately 60 months
|
|
Number of Participants With Anti-Amivantamab Antibodies
Časové okno: Approximately 60 months
|
Number of participants with antibodies to amivantamab will be reported. |
Approximately 60 months
|
|
Change From Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ)
Časové okno: Baseline up to approximately 60 months
|
The NSCLC-SAQ contains 7 items that assess cough, pain, dyspnea, fatigue, and poor appetite over a 7-day recall period. Each multi-item scale and individual item will be summarized using count and percent by visit. |
Baseline up to approximately 60 months
|
|
Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
30. září 2020
Primární dokončení (Aktuální)
11. srpna 2023
Dokončení studie (Odhadovaný)
16. února 2028
Termíny zápisu do studia
První předloženo
23. července 2020
První předloženo, které splnilo kritéria kontroly kvality
23. července 2020
První zveřejněno (Aktuální)
27. července 2020
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. listopadu 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. listopadu 2026
Naposledy ověřeno
1. listopadu 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CR108856
- 2020-000743-31 (Číslo EudraCT)
- 73841937NSC3003 (Jiný identifikátor: Janssen Research & Development, LLC)
- 2023-506576-27-00 (Identifikátor registru: EUCT number)
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .