AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 3MARIPOSA-2NCT04988295

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

A Phase 3 study testing Lazertinib, Amivantamab and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 249 sites in 29 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 adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor… 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?
Lazertinib, Amivantamab and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
776 participants
Where
249 sitesin 29 countries
Study dates
17 Nov 2021to 3 Jul 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 at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated
  • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation
  • A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease
  • Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia [any grade], Grade <= 2 peripheral neuropathy, or Grade <= 2 hypothyroidism stable on hormone replacement)
  • A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
  • Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8)

Who cannot join

  • Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
  • Participant with symptomatic or progressive brain metastases
  • Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
  • Participant has known small cell transformation
  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
  • Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines

Trial locations and contacts

249 sites in 29 countries.

249 sites in 29 countries

China33 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Peking University People's Hospital

    Beijing, 100044

  • Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II

    Beijing, 100142

  • Beijing Cancer Hospital

    Beijing, 100142

  • Chinese PLA General Hospital

    Beijing, 100853

  • Beijing Chest hospital, Capital medical university

    Beijing, 101199

  • Hunan Cancer hospital 1

    Changsha, 410013

  • Hunan Cancer hospital

    Changsha, 410013

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital Sichuan University

    Chengdu, 610041

  • Chongqing University Cancer Hospital

    Chongqing, 400000

  • Southwest Hospital

    Chongqing, 400038

  • Daping Hospital Army Characteristic Medical Center

    Chongqing, 400042

  • 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

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, 637503

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Shanghai East Hospital

    Shanghai, 310000

  • Shenzhen university General Hospital

    Shenzhen, 518055

  • Cancer Hospital Chinese Academy of Medical Sciences

    Shenzhen, 518116

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Weifang People's Hospital

    Weifang, 261000

  • 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 States28 sites

  • University Cancer And Blood Center LLC

    Athens, Georgia, 30607

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Virginia

    Charlottesville, Virginia, 22908

  • TriHealth Network

    Cincinnati, Ohio, 45220

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907

  • Texas Oncology-Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology Baylor Charles A Sammons Cancer Center

    Dallas, Texas, 75246

  • City of Hope

    Duarte, California, 91010

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

    Fort Lauderdale, Florida, 33308

  • Nebraska Cancer Specialists

    Grand Island, Nebraska, 68803

  • Texas Oncology

    Grapevine, Texas, 76051

  • Alliance Cancer Specialists

    Horsham, Pennsylvania, 19044

  • Oncology Consultants Texas

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Texas Oncology - Northeast

    Longview, Texas, 75601

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • Southern Cancer Center, PC

    Mobile, Alabama, 36608

  • University of California Irvine

    Orange, California, 92868

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • NorthWest Medical Specialties, PLLC

    Puyallup, Washington, 98373

  • Arizona Oncology Associates

    Tucson, Arizona, 85711

  • Compass Oncology

    Vancouver, Washington, 98684

  • Blue Ridge Cancer Care

    Wytheville, Virginia, 24382

Other trials in United States

Brazil21 sites

  • Cetus Oncologia

    Belo Horizonte, 30110-017

  • CIONC Centro Integrado de Oncologia de Curitiba

    Curitiba, 80810 050

  • Ynova Pesquisa Clinica

    Florianópolis, 88020-210

  • Fundacao Sao Francisco Xavier

    Ipatinga, 35162 189

  • UPCO Unidade de Pesquisa Clinica em Oncologia

    Pelotas, 96020 080

  • Associacao Hospitalar Moinhos de Vento

    Porto Alegre, 90035-001

  • Hospital Ernesto Dornelles

    Porto Alegre, 90160-093

  • Oncoclinicas Rio de Janeiro S A

    Rio de Janeiro, 22250-905

  • Instituto D Or de Pesquisa e Ensino IDOR

    Rio de Janeiro, 22281 100

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001

  • Nucleo de Oncologia da Bahia

    Salvador, 40170 110

  • IDOR - Regional Bahia

    Salvador, 41253-190

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060 650

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, 01323 900

  • Hospital Paulistano

    São Paulo, 01323-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01327 001

  • IDOR - Regional Sao Paulo

    São Paulo, 01401 002

  • Hospital Nove de Julho

    São Paulo, 01409902

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900

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

    Sorocaba, 18030-005

  • COT - Centro Oncologico do Triangulo S.A

    Uberlândia, 38408-150

Other trials in Brazil

Spain17 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp. Univ. Quiron Dexeus

    Barcelona, 08028

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Majadahonda, 28222

  • Hosp Regional Univ de Malaga

    Málaga, 29010

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

Other trials in Spain

Japan15 sites

  • National Hospital Organization Shibukawa Medical Center

    Gunma, 377-0280

  • Hyogo Cancer Center

    Hyōgo, 673-8558

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

  • Kurume University Hospital

    Kurume, 830-0011

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka International Cancer Institute

    Osaka, 541 8567

  • Shizuoka Cancer Center

    Shizuoka, 411 8777

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    Tokyo, 113 8677

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550

  • Ehime University Hospital

    Toon-shi, 791-0295

  • 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

France13 sites

  • Institut Sainte Catherine

    Avignon, 84918

  • Hospices Civils de Lyon HCL

    Bron, 69500

  • CHU de Grenoble Hopital Albert Michallon

    La Tronche, 38700

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • CHR Hôpital Calmette

    Lille, 59000

  • Hopital Nord

    Marseille, 13915

  • CHU de Montpellier - Arnaud de Villeneuve

    Montpellier, 34295

  • Institut Curie

    Paris, 75005

  • CHU Bordeaux

    Pessac, 33604

  • CHRU Hopital de Pontchaillou

    Rennes, 35033

  • CHU Nantes

    Sain-Herblain, 44800

  • Nouvel Hopital Civil - CHU Strasbourg

    Strasbourg, 67091

  • CHU Bretonneau

    Tours, 37000

Other trials in France

Turkey (Türkiye)10 sites

  • Adana City Hospital

    Adana, 01060

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Gazi University Hospital

    Ankara, 06560

  • Ankara Bilkent City Hospital

    Ankara, 06800

  • Trakya University Medical Faculty

    Edirne, 22030

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Bakirkoy Training and Research Hospital

    Istanbul, 34147

  • Medipol Mega University Hospital

    Istanbul, 34214

  • Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

  • Medical Point

    Izmir, 35575

Other trials in Turkey (Türkiye)

Germany9 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Asklepios Klinikum Harburg

    Hamburg, 21075

  • Thoraxklinik am Universitatsklinikum Heidelberg

    Heidelberg, 69126

  • Onkologische Schwerpunktpraxis

    Heilbronn, 74072

  • POIS Sachsen GmbH iG

    Leipzig, 04357

  • Bethanien Krankenhaus

    Moers, 47441

  • Klinikum der Universitaet Muenchen

    München, 80336

  • Oncologianova GmbH

    Recklinghausen, 45659

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

South Korea9 sites

  • National Cancer Center

    Gyeonggi-do, 10408

  • CHA Bundang Medical Center, CHA University

    Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • GyeongSang National University Hospital

    Gyeongsangnam-do, 52727

  • Korea University Anam Hospital

    Seoul, 02841

  • 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

Other trials in South Korea

Argentina8 sites

  • CINME Centro de Investigaciones Metabolicas

    Caba, C1027AAP

  • IADT Instituto Argentino de Diagnostico y Tratamiento

    CABA, C1122

  • Centro Medico Fleischer

    CABA, C1414

  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

    CABA, C1431FWO

  • Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

    Córdoba, 5000

  • Hospital Privado Universitario De Cordoba

    Córdoba, X5016KEH

  • Hospital Privado de la Comunidad

    Mar del Plata, B7602CBM

  • Clínica Viedma

    Viedma, R8500ACE

Other trials in Argentina

India8 sites

  • Health Care Global Enterprises pvt Ltd

    Bangalore, 560027

  • Artemis Hospital

    Gurugram, 122001

  • Tata Medical Center

    Kolkata, 700160

  • Tata Memorial Hospital

    Mumbai, 400012

  • HCG Manavta Cancer Centre

    Nashik, 422002

  • Rajiv Gandhi Cancer Institute and Research Centre

    New Delhi, 110085

  • Noble Hospital Pvt Ltd

    Pune, 411013

  • Bhaktivedanta Hospital & Research Institute

    Thane, 411107

Other trials in India

Belgium7 sites

  • Grand Hopital De Charleroi Site Les Viviers

    Charleroi, 6060

  • UZA

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • UZ Leuven

    Leuven, 3000

  • CHU Sart-Tilman

    Liège, 4000

  • Clinique Saint Pierre

    Ottignies, 1340

Other trials in Belgium

Israel7 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Health Corporation

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • 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

Italy7 sites

  • CRO IRCCS Istituto Nazionale Tumori

    Aviano, 33081

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

    Meldola, 47014

  • Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliero-Universitaria Di Parma

    Parma, 43126

  • Ospedale S. Maria Delle Croci

    Ravenna, 48121

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

  • Policlinico G.B.Rossi

    Verona, 37134

Other trials in Italy

Poland7 sites

  • Centrum Onkologii im Prof F Lukaszczyka

    Bydgoszcz, 85 796

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80 952

  • Szpitale Pomorskie Sp z o o

    Gdynia, 81 519

  • Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

    Olsztyn, 10-357

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow

    Poznan, 60 569

  • Private Specialist Hospitals - MedPolonia

    Poznan, 60-693

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung Ho Memorial Hospital

    Kaohsiung City, 807

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • Chung Shan Medical University Hospital

    Taichung, 40201

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

United Kingdom6 sites

  • Velindre Hospital

    Cardiff, CF14 2TL

  • Edinburgh Cancer Centre Western General

    Edinburgh, EH4 2XU

  • University College Hospital

    London, NW1 2PG

  • Guys and St Thomas NHS Foundation Trust

    London, SE1 9RT

  • The Royal Marsden NHS Trust

    London, SW3 6JJ

  • The Christie Nhs Foundation Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Malaysia5 sites

  • University Malaya Medical Centre

    Kuala Lumpur

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Beacon Hospital Sdn Bhd

    Petaling Jaya, 46050

  • Subang Jaya Medical Centre

    Subang Jaya, 47500

  • Mount Miriam Cancer Hospital

    Tanjung Bungah, 11200

Other trials in Malaysia

Mexico5 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

  • Oncologia Integral Satelite

    Naucalpan, 53100

Other trials in Mexico

Sweden5 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Linkoping University Hospital

    Linköping, 581 85

  • Skanes universitetssjukhus

    Lund, 221 85

  • Norrlands Universitetssjukhus

    Umeå, 901 85

  • Akademiska Sjukhuset

    Uppsala, 75181

Other trials in Sweden

Bulgaria4 sites

  • Multifunctional Hospital for Active Treatment 'Serdika'

    Sofia, 1303

  • Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

    Sofia, 1407

  • Specialized Hospital for Active Treatment in Oncology

    Sofia, 1756

  • UMHAT Sofia Med

    Sofia, 1797

Other trials in Bulgaria

Portugal4 sites

  • Uls Santa Maria - Hosp. Pulido Valente

    Lisbon, 1769-001

  • Uls Loures Odivelas - Hosp. Loures

    Loures, 2674 514

  • Uls Santo Antonio - Hosp. Santo Antonio

    Porto, 4099-001

  • Instituto Portugues de Oncologia

    Porto, 4200072

Other trials in Portugal

Canada3 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Czechia3 sites

  • Fakultni nemocnice Olomouc - I.P.Pavlova 6

    Olomouc, 775 20

  • Vitkovicka nemocnice a.s.

    Ostrava- Vitkovice, 70300

  • Fakultni nemocnice Plzen

    Pilsen, 30599

Other trials in Czechia

Netherlands3 sites

  • VUMC Amsterdam

    Amsterdam, 1081 HV

  • Ziekenhuis St Jansdal

    Harderwijk, 3844 DG

  • Erasmus MC

    Rotterdam, 3015 GD

Other trials in Netherlands

Russia2 sites

  • City Clinical Hospital #1

    Nal'chik, 360000

  • Llc, Eurocityclinic

    Saint Petersburg, 197022

Other trials in Russia

Denmark1 site

  • Rigshospitalet

    Copenhagen, DK 2100

Other trials in Denmark

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong, 999077

Other trials in Hong Kong

Puerto Rico1 site

  • Pan American Center for Oncology Trials LLC

    Rio Piedras, 00917

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.

Being tested
Lazertinib, Amivantamab, Pemetrexed, Carboplatin
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.

  • LazertinibDrug

    Also called JNJ-73841937, YH-25448

    Lazertinib will be administered orally.

  • AmivantamabDrug

    Also called JNJ-61186372

    Amivantamab will be administered as an IV infusion.

  • PemetrexedDrug

    Pemetrexed will be administered as an IV infusion.

  • CarboplatinDrug

    Carboplatin will be administered as an IV infusion.

Study groups in NCT04988295
Study groupRoleWhat they receive
Arm A: LACP/ACP-LExperimentalLACP dosing (study start until 6 November 2022): Participants will receive Lazertinib orally along with Amivantamab, Pemetrexed, and Carboplatin as IV infusion starting on Cycle 1 Day 1 for 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression. ACP-L dosing (from 7 November 2022 until study completion): Participants will receive Amivantamab, Pemetrexed, and Carboplatin starting on Cycle 1 Day 1 for 4 cycles. Lazertinib in ACP-L will start on Cycle 5 Day 1 or sooner if carboplatin is discontinued before cycle 4 (each cycle consists of 21 days). Beginning with Cycle 5 Day 1, participants will receive Amivantamab, Pemetrexed and Lazertinib as maintenance until disease progression.
Receives: Drug: Lazertinib; Drug: Amivantamab; Drug: Pemetrexed; Drug: Carboplatin
Arm B: CP (Carboplatin and Pemetrexed)Active comparatorParticipants will receive Pemetrexed in combination with Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Pemetrexed as maintenance until disease progression.
Receives: Drug: Pemetrexed; Drug: Carboplatin
Arm C: ACP (Amivantamab, Carboplatin and Pemetrexed)ExperimentalParticipants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.
Receives: Drug: Amivantamab; Drug: Pemetrexed; Drug: Carboplatin
Arm A2 (Extension Cohort): ACP-LExperimentalParticipants will receive Amivantamab, Pemetrexed and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days), Lazertinib will start on C5D1 or sooner if carboplatin is discontinued earlier). After 4 cycles, participants will receive Pemetrexed, Amivantamab, Lazertinib as maintenance until disease progression.
Receives: Drug: Lazertinib; Drug: Amivantamab; Drug: Pemetrexed; Drug: Carboplatin
Arm C2 (Extension Cohort): ACPExperimentalParticipants will receive Amivantamab, Pemetrexed, and Carboplatin as IV infusion for up to 4 cycles (each cycle consists of 21 days). After 4 cycles, participants will receive Amivantamab and Pemetrexed as maintenance until disease progression.
Receives: Drug: Amivantamab; Drug: Pemetrexed; Drug: Carboplatin

What is being measured

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

  1. Main Study: 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 is defined as the time from randomization until the date of objective disease progression or death, whichever came first, as assessed by BICR according to RECIST version 1.1. Progressed disease: Sum of diameters increased by greater than or equal to (>=)20 percent (%) and >=5 millimeter (mm) from nadir (including baseline if it was smallest sum).

    Measured: From randomization to either disease progression or death, whichever occurred first (up to 1 year 7 months)

  2. Main Study + Extension Cohort: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    Follow-up for the extension cohort is still ongoing and thus results from the analysis that includes the extension cohort will be reported up on study completion.

    Measured: up to 4 years 10 months

  3. Main Study + Extension Cohort: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review

    Measured: Up to 4 years 10 months

Secondary outcomes (16)

  1. Main Study+ Extension Cohort: Objective Response Rate as Assessed by Blinded Independent Central Review

    Measured: Up to 4 years 10 months

  2. Main Study+ Extension Cohort: Overall Survival

    Measured: Up to 4 years 10 months

  3. Main Study+ Extension Cohort: Duration of Response as Assessed by Blinded Independent Central Review

    Measured: Up to 4 years 10 months

  4. Main Study+ Extension Cohort: Time to Subsequent Therapy

    Measured: Up to 4 years 10 months

  5. Main Study+ Extension Cohort: Progression-free Survival (PFS) After First Subsequent Therapy (PFS2)

    Measured: Up to 4 years 10 months

  6. Main Study+ Extension Cohort: Time to Symptomatic Progression

    Measured: Up to 4 years 10 months

  7. Main Study+ Extension Cohort: Intracranial Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review

    Measured: Up to 4 years 10 months

  8. Main Study: Number of Participants With Adverse Events (AEs)

    Measured: Up to 4 years 10 months

  9. Main Study+ Extension Cohort: Number of Participants With Adverse Events (AEs) by Severity

    Measured: Up to 4 years 10 months

  10. Main Study+ Extension Cohort: Number of Participants With Clinical Laboratory Abnormalities

    Measured: Up to 4 years 10 months

  11. Main Study+ Extension Cohort: Serum Concentration of Amivantamab

    Measured: Up to 4 years 10 months

  12. Main Study+ Extension Cohort: Plasma Concentration of Lazertinib

    Measured: Up to 4 years 10 months

  13. Main Study + Extension Cohort: Number of Participants With Serum Anti-amivantamab Antibodies

    Measured: Up to 4 years 10 months

  14. Main Study+ Extension Cohort: Change From Baseline With Non-Small Cell Lung Cancer - Symptom Assessment Questionnaire (NSCLC-SAQ)

    Measured: Up to 4 years 10 months

  15. Main Study+ Extension Cohort: Change From Baseline With European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

    Measured: Up to 4 years 10 months

  16. Main Study+ Extension Cohort: Change From Baseline With Patient-Reported Outcomes Measurement Information System -Physical Function (PROMIS-PF)

    Measured: Up to 4 years 10 months

Timeline

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

  1. First posted3 Aug 2021
  2. Study start17 Nov 2021
  3. Primary completion10 Jul 2023
  4. Study completion3 Jul 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
None (open label)
Enrolment
776 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04988295
Sponsor's protocol ID
CR109061
Other IDs
61186372NSC3002, 2021-001825-33, 2023-506518-33-00, 2023
Acronym
MARIPOSA-2
Status last verified
Nov 2026
First submitted
30 Jul 2021
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 the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/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
Expanded access
Available

Publications

  • Shih JY, Wang J, Wang Y, Wang J, Lee SH, Azuma K, Takahashi T, Tan JL, Lin CC, Ganguly S, Lee VH, Turna ZH, Sharma R, Kim YJ, Chu PL, Shah S, Diorio B, Cho BC. Amivantamab plus chemotherapy vs. chemotherapy in participants with EGFR-mutant advanced non-small cell lung cancer after progression on osimertinib: a MARIPOSA-2 analysis of the Asian subgroup. Transl Lung Cancer Res. 2026 Sep 30;15(9):284. doi: 10.21037/tlcr-2026-0202. Epub 2026 Sep 24.

    PubMed 42870814

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lazertinib, Amivantamab and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 249 sites in 29 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 7 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 249 sites in China, United States, Brazil, Spain, Japan and 24 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 16 Apr 2025). 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?

Main Study: 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 occurred first (up to 1 year 7 months)). The study lists 3 primary outcomes in all. 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 NCT04988295, which also lists 1 linked publication.

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; AzTrials last refreshed its copy on 7 Nov 2026.

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