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A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: Janssen Research & Development, LLC
Summary
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).
Official title: A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib Versus Lazertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1074
Start Date
2020-09-30
Completion Date
2027-06-29
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Amivantamab
Participants will receive amivantamab intravenously.
Osimertinib
Participants will receive osimertinib capsules orally.
Lazertinib
Participants will receive lazertinib tablets orally.
Placebo
Participants will receive matching placebo orally.
Locations (267)
Arizona Oncology Associates, PC - HAL
Goodyear, Arizona, United States
Yuma Regional Medical Center
Yuma, Arizona, United States
City of Hope Long Beach Elm
Long Beach, California, United States
University of California Irvine
Orange, California, United States
Rocky Mountain Cancer Centers
Lone Tree, Colorado, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
University Cancer And Blood Center LLC
Athens, Georgia, United States
East Jefferson General Hospital
Metairie, Louisiana, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minnesota Oncology Hematology P A
Edina, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Astera Cancer Care
East Brunswick, New Jersey, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology P A
Austin, Texas, United States
Oncology Consultants Texas
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Centro Oncológico Korben
Buenos Aires, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, Argentina
Centro Oncologico Riojano Integral (Cori)
La Rioja, Argentina
Clínica Viedma
Viedma, Argentina
Flinders Medical Centre
Bedford Park, Australia
Austin Hospital
Heidelberg, Australia
Cabrini Medical Centre
Malvern, Australia
St John of God Hospital Murdoch
Murdoch, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Westmead Hospital
Westmead, Australia
Southern Medical Day Care Centre
Wollongong, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Cliniques Universitaires Saint Luc
Brussels, Belgium
Grand Hopital De Charleroi Site Les Viviers
Charleroi, Belgium
UZ Leuven
Leuven, Belgium
Clinique Saint Pierre
Ottignies, Belgium
Algemeen Ziekenhuis Delta
Roeselare, Belgium
Fundacao Pio XII
Barretos, Brazil
Cetus Oncologia
Belo Horizonte, Brazil
Ynova Pesquisa Clinica
Florianópolis, Brazil
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
Ijuí, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, Brazil
UPCO Unidade de Pesquisa Clinica em Oncologia
Pelotas, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, Brazil
Ministerio da Saude Instituto Nacional do Cancer
Rio de Janeiro, Brazil
Oncoclinicas Rio de Janeiro S A
Rio de Janeiro, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
Rio de Janeiro, Brazil
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, Brazil
Núcleo de Pesquisa São Camilo
São Paulo, Brazil
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
Sorocaba, Brazil
Hospital Evangélico de Cachoeiro de Itapemirim
Vitória, Brazil
William Osler Health System
Brampton, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Beijing Friendship Hospital Capital Medical University
Beijing, China
Beijing Cancer Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
Beijing Chest hospital, Capital medical university
Beijing, China
Jilin cancer hospital
Changchun, China
Hunan Cancer hospital
Changsha, China
The First People's Hospital Of Changzhou
Changzhou, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital Sichuan University
Chengdu, China
Southwest Hospital
Chongqing, China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, China
Sun Yat-Sen Memorial Hospital Sun Yat-sen University
Guangzhou, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin medical university cancer hospital
Harbin, China
Huizhou Municipal Central Hospital
Huizhou, China
Taizhou Hospital of Zhejiang Province
Linhai, China
Nantong Tumor Hospital
Nantong, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanghai East Hospital
Shanghai, China
Shengjing Hospital Of China Medical University
Shenyang, China
Tianjin Medical University General Hospital
Tianjin, China
Cancer Hospital of Xinjiang Medical University
Ürümqi, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
Wuhan, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, China
Yantai Yuhuangding Hospital
Yantai, China
Henan Cancer Hospital
Zhengzhou, China
Institut Bergonie
Bordeaux, France
Hospices Civils de Lyon HCL
Bron, France
CHU de Grenoble Hopital Albert Michallon
La Tronche, France
Institute Coeur Poumon
Lille, France
CHU de Limoges
Limoges, France
Hopital Nord
Marseille, France
Institut Curie
Paris, France
Hopital Tenon
Paris, France
CHU Bordeaux
Pessac, France
CHU Nantes
Sain-Herblain, France
HIA Begin
Saint-Mandé, France
CHU Bretonneau
Tours, France
Institut Gustave Roussy
Villejuif, France
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Helios Klinikum Emil von Behring GmbH
Berlin, Germany
Kliniken der Stadt Koeln gGmbH
Cologne, Germany
Universitaetsklinikum Essen
Essen, Germany
Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting
Gauting, Germany
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, Germany
Thoraxklinik am Universitatsklinikum Heidelberg
Heidelberg, Germany
Onkologische Schwerpunktpraxis
Heilbronn, Germany
POIS Leipzig GbR
Leipzig, Germany
Pius-Hospital Oldenburg
Oldenburg, Germany
Robert-Bosch-Krankenhaus - Klinik Schillerhoehe
Stuttgart, Germany
Orszagos Koranyi Tbc es Pulmonologiai Intezet
Budapest, Hungary
Veszprém Megyei Tudőgyógyintézet
Farkasgyepü, Hungary
Mátrai Gyógyintézet-Bronchológia
Gyöngyös, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
Székesfehérvár, Hungary
Markusovszky Egyetemi Oktatokorhaz
Szombathely, Hungary
Tudogyogyintezet Torokbalint
Törökbálint, Hungary
Basavatarakam Indo-American Hospital
Hyderabad, India
Tata Medical Center
Kolkata, India
Tata Memorial Hospital
Mumbai, India
HCG Manavta Cancer Centre
Nashik, India
Noble Hospital Pvt Ltd
Pune, India
Rambam Health Corporation
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Ospedale San Giuseppe Moscati di Avellino
Avellino, Italy
Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico
Catania, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
San Gerardo Hospital
Monza, Italy
Ospedale Monaldi
Naples, Italy
Aou San Luigi Gonzaga
Orbassano, Italy
Ospedale S. Maria Delle Croci
Ravenna, Italy
Irccs Gemelli
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Juntendo University Hospital
Bunkyō City, Japan
National Cancer Center Hospital
Chūōku, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
National Hospital Organization Himeji Medical Center
Himeji, Japan
Kansai Medical University Hospital
Hirakata, Japan
Kanazawa University Hospital
Kanazawa, Japan
National Cancer Center Hospital East
Kashiwa, Japan
Kurume University Hospital
Kurume, Japan
Matsusaka Municipal Hospital
Matsusaka, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Okayama University Hospital
Okayama, Japan
Kindai University Hospital
Osaka Sayama Shi, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
National Hospital Organization Tokyo Medical Center
Tokyo, Japan
Ehime University Hospital
Toon-shi, Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka-shi, Japan
Wakayama Medical University Hospital
Wakayama, Japan
National Hospital Organization Iwakuni Clinical Center
Yamaguchi, Japan
National Hospital Organization Yamaguchi Ube Medical Center
Yamaguchi, Japan
Hospital Pulau Pinang
George Town, Malaysia
Hospital Sultan Ismail
Johor Bahru, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia
Beacon Hospital Sdn Bhd
Petaling Jaya, Malaysia
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Mexico
CIMOVA, Morals Vargas Centro de Investigación SC
León, Mexico
Mexico Centre for Clinical Research, S.A. de C.V.
Mexico City, Mexico
Médica Sur
Mexico City, Mexico
Health Pharma Professional Research
México, Mexico
Instituto Nacional de Cancerologia
México, Mexico
i Can Oncology Center
Monterrey, Mexico
Oncologia Integral Satelite
Naucalpan, Mexico
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Rijnstate Ziekenhuis
Arnhem, Netherlands
Ziekenhuis St Jansdal
Harderwijk, Netherlands
UMC Radboud
Nijmegen, Netherlands
Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland
Szpitale Pomorskie Sp z o o
Gdynia, Poland
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, Poland
Private Specialist Hospitals - MedPolonia
Poznan, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, Poland
Uls Santa Maria - Hosp. Pulido Valente
Lisbon, Portugal
Uls Santo Antonio - Hosp. Santo Antonio
Porto, Portugal
Hosp. Cuf Porto
Porto, Portugal
Instituto Portugues de Oncologia
Porto, Portugal
Pan American Center for Oncology Trials LLC
Rio Piedras, Puerto Rico
Irkutsk Regional Oncology Dispensary
Irkutsk, Russia
Moscow City Oncology Hospital № 62
Krasnogorsk, Russia
Krasnoyarsk Regional Oncology Dispensary
Krasnoyarsk, Russia
Leningrad Regional Oncology Dispensary
Kuzmolovsky, Russia
MCK
Moscow, Russia
City Clinical Hospital #1
Nal'chik, Russia
Nizhny Novgorod Regional Oncological Dispensary
Nizhny Novgorod, Russia
Omsk Clinical Oncology Dispensary
Omsk, Russia
Current medical technologies
Saint Petersburg, Russia
Oncology Medical Clinics AV Medical group
Saint Petersburg, Russia
N.N. Petrov Research Institute Of Oncology
Saint Petersburg, Russia
Tambov Regional Oncology Clinical Dispansary
Tambov, Russia
Tomsk Cancer Research Institute
Tomsk, Russia
Bashkir State Medical University
Ufa, Russia
Yaroslavl Regional Clinical Oncology Hospital
Yaroslavl, Russia
Inje University Haeundae Paik Hospital
Busan, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Severance Hospital Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Hosp Univ A Coruna
A Coruña, Spain
Inst. Cat. D'Oncologia-Badalona
Badalona, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain
Hosp. Univ. Quiron Dexeus
Barcelona, Spain
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. Univ. de Burgos
Burgos, Spain
Institut Català D'Oncologia Girona
Girona, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, Spain
Hosp. Univ. 12 de Octubre
Madrid, Spain
Hosp. Univ. La Paz
Madrid, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, Spain
Hosp Regional Univ de Malaga
Málaga, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp. Virgen Del Rocio
Seville, Spain
Hosp. Gral. Univ. Valencia
Valencia, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, Taiwan
E-DA Hospital
Kaohsiung City, Taiwan
Chang Gung Medical Foundation
Kaohsiung City, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Phramongkutklao Hospital and Medical College
Bangkok, Thailand
Siriraj Hospital
Bangkok, Thailand
Chiang Mai University
Chiang Mai, Thailand
Songklanagarind Hospital, Prince of Songkla University
Songkhla, Thailand
Adana City Hospital
Adana, Turkey (Türkiye)
Başkent University Medical Faculty Adana Application and Research Center
Adana, Turkey (Türkiye)
Gazi University Hospital
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Trakya University Medical Faculty
Edirne, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
Istanbul, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, Turkey (Türkiye)
T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi
Istanbul, Turkey (Türkiye)
Medical Point
Izmir, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye)
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
Dnipro, Ukraine
Municipal non-profit enterprise 'Regional Center of Oncology'
Kharkiv, Ukraine
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
Kyiv, Ukraine
National Cancer Institute
Kyiv, Ukraine
Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal
Uzhhorod, Ukraine
Edinburgh Cancer Centre Western General
Edinburgh, United Kingdom
UCL Cancer Institute
London, United Kingdom
Chelsea And Westminster Hospital
London, United Kingdom
The Royal Marsden NHS Trust
London, United Kingdom
Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
The Royal Marsden NHS Trust
Sutton, United Kingdom