AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3MARIPOSANCT04487080

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 3 study testing Amivantamab, Osimertinib and Lazertinib in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 269 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Amivantamab, Osimertinib and Lazertinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,074 participants
Where
269 sitesin 28 countries
Study dates
30 Sep 2020to 16 Feb 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

269 sites in 28 countries.

269 sites in 28 countries

China34 sites

  • Beijing Friendship Hospital Capital Medical University

    Beijing, 100050

  • Beijing Cancer Hospital Respiratory Medicine Department II

    Beijing, 100142

  • Beijing Cancer Hospital Respiratory Medicine Department I

    Beijing, 100142

  • Chinese PLA General Hospital

    Beijing, 100853

  • Beijing Chest hospital, Capital medical university

    Beijing, 101149

  • Jilin cancer hospital

    Changchun, 130000

  • Hunan Cancer hospital Thoracic Medicine Department II

    Changsha, 410013

  • Hunan Cancer hospital Thoracic Medicine Department I

    Changsha, 410013

  • The First People's Hospital Of Changzhou

    Changzhou, 213003

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Southwest Hospital

    Chongqing, 400038

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

  • Sun Yat-Sen Memorial Hospital Sun Yat-sen University

    Guangzhou, 510120

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310009

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, 310009

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, 310016

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin medical university cancer hospital

    Harbin, 150000

  • Huizhou Municipal Central Hospital

    Huizhou, 516001

  • Taizhou Hospital of Zhejiang Province

    Linhai, 317000

  • Nantong Tumor Hospital

    Nantong, 226300

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai East Hospital

    Shanghai, 200123

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Cancer Hospital of Xinjiang Medical University

    Ürümqi, 830000

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

  • TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

    Wuhan, 430030

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

  • Yantai Yuhuangding Hospital

    Yantai, 264000

  • Henan Cancer Hospital

    Zhengzhou, 450008

Other trials in China

United States20 sites

  • University Cancer And Blood Center LLC

    Athens, Georgia, 30607

  • Texas Oncology P A

    Austin, Texas, 78745

  • Maryland Oncology Hematology, PA

    Columbia, Maryland, 21044

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Minnesota Oncology Hematology P A

    Edina, Minnesota, 55435

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Arizona Oncology Associates, PC - HAL

    Goodyear, Arizona, 85395

  • Oncology Consultants Texas

    Houston, Texas, 77030

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • City of Hope Long Beach Elm

    Long Beach, California, 90813

  • East Jefferson General Hospital

    Metairie, Louisiana, 70006

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • University of California Irvine

    Orange, California, 92868

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

Japan20 sites

  • Juntendo University Hospital

    Bunkyō City, 113 8431

  • National Cancer Center Hospital

    Chūōku, 104 0045

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • National Hospital Organization Himeji Medical Center

    Himeji, 670-8520

  • Kansai Medical University Hospital

    Hirakata, 573 1191

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

  • Kurume University Hospital

    Kurume, 830-0011

  • Matsusaka Municipal Hospital

    Matsusaka, 515-8544

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Okayama University Hospital

    Okayama, 700 8558

  • Kindai University Hospital

    Osaka Sayama Shi, 589 8511

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa, 377-0280

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

  • National Hospital Organization Tokyo Medical Center

    Tokyo, 152 8902

  • Ehime University Hospital

    Toon-shi, 791-0295

  • National Hospital Organization Osaka Toneyama Medical Center

    Toyonaka-shi, 560-8552

  • Wakayama Medical University Hospital

    Wakayama, 641 8510

  • National Hospital Organization Iwakuni Clinical Center

    Yamaguchi, 740-8510

  • National Hospital Organization Yamaguchi Ube Medical Center

    Yamaguchi, 755-0241

Other trials in Japan

Brazil16 sites

  • Fundacao Pio XII

    Barretos, 14784-400

  • Cetus Oncologia

    Belo Horizonte, 30110-022

  • Ynova Pesquisa Clinica

    Florianópolis, 88020-210

  • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

    Ijuí, 98700-000

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000

  • UPCO Unidade de Pesquisa Clinica em Oncologia

    Pelotas, 96020 080

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90020-090

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20231 050

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22 250 905

  • IDOR - Regional Rio de Janeiro

    Rio de Janeiro, 22281 100

  • Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246 000

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002

  • IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

    Sorocaba, 18030-075

  • Hospital Evangélico de Cachoeiro de Itapemirim

    Vitória, 29308-014

Other trials in Brazil

Spain16 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Inst. Cat. D'Oncologia-Badalona

    Badalona, 08916

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Univ. de Burgos

    Burgos, 09003

  • Institut Català D'Oncologia Girona

    Girona, 17007

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222

  • Hosp Regional Univ de Malaga

    Málaga, 29011

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

  • Hosp. Clinico Univ. Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Russia15 sites

  • Irkutsk Regional Oncology Dispensary

    Irkutsk, 664035

  • Krasnoyarsk Regional Oncology Dispensary

    Krasnoyarsk, 660133

  • Leningrad Regional Oncology Dispensary

    Kuzmolovsky, 188663

  • MCK

    Moscow, 115533

  • Moscow City Oncology Hospital No 62

    Moscow, 121205

  • City Clinical Hospital #1

    Nal'chik, 360000

  • Nizhny Novgorod Regional Oncological Dispensary

    Nizhny Novgorod, 603000

  • Omsk Clinical Oncology Dispensary

    Omsk, 664013

  • Current medical technologies

    Saint Petersburg, 190121

  • Oncology Medical Clinics AV Medical group

    Saint Petersburg, 196006

  • N.N. Petrov Research Institute Of Oncology

    Saint Petersburg, 197758

  • Tambov Regional Oncology Clinical Dispansary

    Tambov, 392013

  • Tomsk Cancer Research Institute

    Tomsk, 634050

  • Bashkir State Medical University

    Ufa, 450083

  • Yaroslavl Regional Clinical Oncology Hospital

    Yaroslavl, 150054

Other trials in Russia

France13 sites

  • Institut Bergonie

    Bordeaux, 33000

  • Hospices Civils de Lyon HCL

    Bron, 69500

  • CHU de Grenoble Hopital Albert Michallon

    La Tronche, 38700

  • Institute Coeur Poumon

    Lille, 59000

  • CHU de Limoges

    Limoges, 87000

  • Hopital Nord

    Marseille, 13915

  • Institut Curie

    Paris, 75005

  • Hopital Tenon

    Paris, 75970

  • CHU Bordeaux

    Pessac, 33604

  • CHU Nantes

    Sain-Herblain, 44800

  • HIA Begin

    Saint-Mandé, 94163

  • CHU Bretonneau

    Tours, 37000

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy13 sites

  • Ospedale San Giuseppe Moscati di Avellino

    Avellino, 83100

  • Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

    Catania, 95123

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, 47014

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Europeo di Oncologia

    Milan, 20141

  • San Gerardo Hospital

    Monza, 20052

  • Ospedale Monaldi

    Naples, 80100

  • Aou San Luigi Gonzaga

    Orbassano, 10043

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

  • Irccs Gemelli

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

Germany11 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99437

  • Helios Klinikum Emil von Behring GmbH

    Berlin, 14165

  • Kliniken der Stadt Koeln gGmbH

    Cologne, 51109

  • Universitaetsklinikum Essen

    Essen, 45147

  • Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

    Gauting, 82131

  • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

    Halle, 06120

  • Thoraxklinik am Universitatsklinikum Heidelberg

    Heidelberg, 69126

  • Onkologische Schwerpunktpraxis

    Heilbronn, 74072

  • POIS Leipzig GbR

    Leipzig, 04357

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

  • Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

    Stuttgart, 70376

Other trials in Germany

Turkey (Türkiye)10 sites

  • Adana City Hospital

    Adana, 01060

  • Başkent University Medical Faculty Adana Application and Research Center

    Adana, 01250

  • Gazi Hastanesi

    Ankara, 06560

  • Ankara Bilkent City Hospital

    Ankara, 6800

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

    Istanbul, 34098

  • Medipol Mega University Hospital

    Istanbul, 34214

  • T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

    Istanbul, 34722

  • Medical Point

    Izmir, 35575

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

Other trials in Turkey (Türkiye)

South Korea9 sites

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Mary s Hospital

    Seoul, 06591

  • Korea University Guro Hospital

    Seoul, 8308

Other trials in South Korea

Australia8 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Austin Hospital

    Heidelberg, 3084

  • Cabrini Medical Centre

    Malvern, 3144

  • St John of God Hospital Murdoch

    Murdoch, 6150

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Westmead Hospital

    Westmead, 2145

  • Southern Medical Day Care Centre

    Wollongong, 2500

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Mexico8 sites

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280

  • CIMOVA, Morals Vargas Centro de Investigación SC

    León, 37000

  • Health Pharma Professional Research

    México, 03100

  • Instituto Nacional de Cancerologia

    México, 14080

  • Mexico Centre for Clinical Research, S.A. de C.V.

    Mexico City, 03100

  • Médica Sur

    Mexico City, 14050

  • i Can Oncology Center

    Monterrey, 64710

  • Oncologia Integral Satelite

    Naucalpan, 53100

Other trials in Mexico

Taiwan8 sites

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • E-DA Hospital

    Kaohsiung City, 824

  • Chang Gung Medical Foundation

    Kaohsiung City, 833

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • Chung Shan Medical University Hospital

    Taichung, 402

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

United Kingdom7 sites

  • Edinburgh Cancer Centre Western General

    Edinburgh, EH4 2XU

  • UCL Cancer Institute

    London, NW1 2PG

  • Chelsea And Westminster Hospital

    London, SW10 9NH

  • The Royal Marsden NHS Trust

    London, SW3 6JJ

  • Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • The Royal Marsden NHS Trust 1

    Sutton, SM2 5PT

Other trials in United Kingdom

Hungary6 sites

  • Orszagos Koranyi Tbc es Pulmonologiai Intezet

    Budapest, H-1529

  • Veszprém Megyei Tudőgyógyintézet

    Farkasgyepü, 8582

  • Mátrai Gyógyintézet-Bronchológia

    Gyöngyös, 3233

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

    Székesfehérvár, 8000

  • Markusovszky Egyetemi Oktatokorhaz

    Szombathely, 9700

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

Other trials in Hungary

Israel6 sites

  • Rambam Health Corporation

    Haifa, 3109601

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Malaysia6 sites

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Sultan Ismail

    Johor Bahru, 81100

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Beacon Hospital Sdn Bhd

    Petaling Jaya, 46050

Other trials in Malaysia

Poland6 sites

  • Centrum Onkologii im Prof F Lukaszczyka

    Bydgoszcz, 85 796

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 214

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81 519

  • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

    Olsztyn, 10-357

  • Private Specialist Hospitals - MedPolonia

    Poznan, 60-693

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Argentina5 sites

  • Centro Oncológico Korben

    Buenos Aires, C1426AGE

  • Instituto Alexander Fleming

    Buenos Aires, C1428ANZ

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Centro Oncologico Riojano Integral (Cori)

    La Rioja, F5300COE

  • Clínica Viedma

    Viedma, R8500ACE

Other trials in Argentina

Belgium5 sites

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Grand Hopital De Charleroi Site Les Viviers

    Charleroi, 6060

  • UZ Leuven

    Leuven, 3000

  • Clinique Saint Pierre

    Ottignies, 1340

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

Other trials in Belgium

India5 sites

  • Basavatarakam Indo-American Hospital

    Hyderabad, 500034

  • Tata Medical Center

    Kolkata, 700160

  • Tata Memorial Hospital

    Mumbai, 400012

  • HCG Manavta Cancer Centre

    Nashik, 422002

  • Noble Hospital Pvt Ltd

    Pune, 411013

Other trials in India

Ukraine5 sites

  • Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

    Dnipro, 49102

  • Municipal non-profit enterprise 'Regional Center of Oncology'

    Kharkiv, 61070

  • Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

    Kyiv, 02091

  • State Nonprofit Enterprise National Cancer Institute

    Kyiv, 03022

  • Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

    Uzhhorod, 88000

Other trials in Ukraine

Canada4 sites

  • William Osler Health System

    Brampton, Ontario, L6R 3J7

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Netherlands4 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Rijnstate Ziekenhuis

    Arnhem, 6815 AD

  • Ziekenhuis St Jansdal

    Harderwijk, 3844 DG

  • UMC Radboud

    Nijmegen, 6525AG

Other trials in Netherlands

Portugal4 sites

  • Uls Santa Maria - Hosp. Pulido Valente

    Lisbon, 1769-001

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4099-001

  • Hosp. Cuf Porto

    Porto, 4100 180

  • Instituto Portugues de Oncologia

    Porto, 4200-072

Other trials in Portugal

Thailand4 sites

  • Phramongkutklao Hospital and Medical College

    Bangkok, 10400

  • Siriraj Hospital

    Bangkok, 10700

  • Chiang Mai University

    Chiang Mai, 50200

  • Songklanagarind Hospital, Prince of Songkla University

    Songkhla, 90110

Other trials in Thailand

Puerto Rico1 site

  • Pan American Center for Oncology Trials LLC

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

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.

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).

Being tested
Amivantamab, Osimertinib, Lazertinib, Placebo
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmivantamabDrug

    Also called JNJ-61186372

    Participants will receive amivantamab intravenously.

  • OsimertinibDrug

    Participants will receive osimertinib capsules orally.

  • LazertinibDrug

    Also called JNJ-73841937 and YH-25448

    Participants will receive lazertinib tablets orally.

  • PlaceboDrug

    Participants will receive matching placebo orally.

Study groups in NCT04487080
Study groupRoleWhat they receive
Treatment Arm A (Open-label): Amivantamab and LazertinibExperimentalParticipants 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.
Receives: Drug: Amivantamab; Drug: Lazertinib
Treatment Arm B (Double-blind): Osimertinib+Placebo LazertinibActive comparatorParticipants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80*3) orally once daily.
Receives: Drug: Osimertinib; Drug: Placebo
Treatment Arm C (Double-blind): Lazertinib+Placebo OsimertinibExperimentalParticipants will receive lazertinib 240 mg (80*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.
Receives: Drug: Lazertinib; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)

    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.

    Measured: From randomization to either disease progression or death whichever occurs first (up to 32.8 months)

Secondary outcomes (15)

  1. Overall Survival (OS)

    Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

    Measured: Approximately 60 months (time from the date of randomization until the date of death due to any cause)

  2. Objective Response Rate (ORR)

    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.

    Measured: Approximately 32.8 months

  3. Duration of Response (DOR)

    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.

    Measured: Approximately 32.8 months

  4. Progression-Free Survival After First Subsequent Therapy (PFS2)

    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.

    Measured: Approximately 60 months

  5. Time to Symptomatic Progression (TTSP)

    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.

    Measured: Approximately 60 months

  6. Intracranial PFS

    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.

    Measured: Approximately 60 months

  7. Incidence and Severity of Adverse Events (AEs)

    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.

    Measured: Approximately 60 months

  8. Number of Participants With Clinical Laboratory Abnormalities

    Number of participants with clinical laboratory abnormalities (serum chemistry, hematology, blood coagulation, and urine samples) will be reported.

    Measured: Approximately 60 months

  9. Number of Participants With Vital Signs Abnormalities

    Number of participants with vital signs abnormalities (temperature, heart rate, respiratory rate, oxygen saturation, blood pressure) will be reported.

    Measured: Approximately 60 months

  10. Number of Participants With Physical Examination Abnormalities

    Number of participants with physical examination abnormalities will be reported.

    Measured: Approximately 60 months

  11. Serum Concentration of Amivantamab

    Serum samples will be analyzed to determine concentrations of Amivantamab.

    Measured: Approximately 60 months

  12. Plasma Concentration of Lazertinib

    Plasma samples will be analyzed to determine concentrations of Lazertinib.

    Measured: Approximately 60 months

  13. Number of Participants With Anti-Amivantamab Antibodies

    Number of participants with antibodies to amivantamab will be reported.

    Measured: Approximately 60 months

  14. Change From Baseline in Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NCSLC-SAQ)

    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.

    Measured: Baseline up to approximately 60 months

  15. Change From Baseline in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

    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.

    Measured: Baseline up to approximately 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2020
  2. Study start30 Sep 2020
  3. Primary completion11 Aug 2023
  4. Study completion16 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,074 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04487080
Sponsor's protocol ID
CR108856
Other IDs
73841937NSC3003, 2020-000743-31, 2023-506576-27-00, 2023
Acronym
MARIPOSA
Status last verified
Nov 2026
First submitted
23 Jul 2020
Last updated
4 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 40923797

  • 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.

    PubMed 40617394

  • 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.

    PubMed 38924756

  • 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.

    PubMed 34911336

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Amivantamab, Osimertinib and Lazertinib in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 269 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 269 sites in China, United States, Japan, Brazil, Spain and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR) (time frame: From randomization to either disease progression or death whichever occurs first (up to 32.8 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04487080, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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