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

NCT04487080 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 4 other identifiers: CR10885673841937NSC30032020-000743-312023-506576-27-00
• Study Type: interventional
• Target: 1,074
• Locations: 28 countries
• Sites: 269

Brief 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).

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (15)

• Overall Survival (OS)

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

• Objective Response Rate (ORR)

  Approximately 32.8 months

• Duration of Response (DOR)

  Approximately 32.8 months

• Progression-Free Survival After First Subsequent Therapy (PFS2)

  Approximately 60 months

• Time to Symptomatic Progression (TTSP)

  Approximately 60 months

Study Arms (3)

Treatment Arm A (Open-label): Amivantamab and Lazertinib

EXPERIMENTAL

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.

Drug: Amivantamab; Drug: Lazertinib

Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib

ACTIVE COMPARATOR

Participants will receive osimertinib 80 mg orally once daily plus matching placebo of lazertinib 240 mg (80\*3) orally once daily.

Drug: Osimertinib; Drug: Placebo

Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib

EXPERIMENTAL

Participants will receive lazertinib 240 mg (80\*3) orally once daily plus matching placebo of osimertinib 80 mg orally once daily.

Drug: Lazertinib; Drug: Placebo

Interventions

Amivantamab DRUG

Participants will receive amivantamab intravenously.

Also known as: JNJ-61186372

Treatment Arm A (Open-label): Amivantamab and Lazertinib

Osimertinib DRUG

Participants will receive osimertinib capsules orally.

Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib

Lazertinib DRUG

Participants will receive lazertinib tablets orally.

Also known as: JNJ-73841937 and YH-25448

Treatment Arm A (Open-label): Amivantamab and Lazertinib; Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib

Placebo DRUG

Participants will receive matching placebo orally.

Treatment Arm B (Double-blind): Osimertinib+Placebo Lazertinib; Treatment Arm C (Double-blind): Lazertinib+Placebo Osimertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (269)

Arizona Oncology Associates, PC - HAL

Goodyear, Arizona, 85395, United States

Location

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

City of Hope Long Beach Elm

Long Beach, California, 90813, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Rocky Mountain Cancer Centers

Lone Tree, Colorado, 80124, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

Location

University Cancer And Blood Center LLC

Athens, Georgia, 30607, United States

Location

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

Location

Maryland Oncology Hematology, PA

Columbia, Maryland, 21044, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Minnesota Oncology Hematology P A

Edina, Minnesota, 55435, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

Location

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, 97401, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Texas Oncology P A

Austin, Texas, 78745, United States

Location

Oncology Consultants Texas

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Centro Oncológico Korben

Buenos Aires, C1426AGE, Argentina

Location

Instituto Alexander Fleming

Buenos Aires, C1428ANZ, Argentina

Location

Hospital Privado Centro Medico de Cordoba

Córdoba, X5016KEH, Argentina

Location

Centro Oncologico Riojano Integral (Cori)

La Rioja, F5300COE, Argentina

Location

Clínica Viedma

Viedma, R8500ACE, Argentina

Location

Flinders Medical Centre

Bedford Park, 5042, Australia

Location

Austin Hospital

Heidelberg, 3084, Australia

Location

Cabrini Medical Centre

Malvern, 3144, Australia

Location

St John of God Hospital Murdoch

Murdoch, 6150, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, 6009, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

Southern Medical Day Care Centre

Wollongong, 2500, Australia

Location

Princess Alexandra Hospital

Woolloongabba, 4102, Australia

Location

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

Grand Hopital De Charleroi Site Les Viviers

Charleroi, 6060, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Clinique Saint Pierre

Ottignies, 1340, Belgium

Location

Algemeen Ziekenhuis Delta

Roeselare, 8800, Belgium

Location

Fundacao Pio XII

Barretos, 14784-400, Brazil

Location

Cetus Oncologia

Belo Horizonte, 30110-022, Brazil

Location

Ynova Pesquisa Clinica

Florianópolis, 88020-210, Brazil

Location

Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

Ijuí, 98700-000, Brazil

Location

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000, Brazil

Location

UPCO Unidade de Pesquisa Clinica em Oncologia

Pelotas, 96020 080, Brazil

Location

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90020-090, Brazil

Location

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, 90610-000, Brazil

Location

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, 20231 050, Brazil

Location

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, 22 250 905, Brazil

Location

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, 22281 100, Brazil

Location

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

São Paulo, 01246 000, Brazil

Location

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, 01509 900, Brazil

Location

Núcleo de Pesquisa São Camilo

São Paulo, 04014-002, Brazil

Location

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Sorocaba, 18030-075, Brazil

Location

Hospital Evangélico de Cachoeiro de Itapemirim

Vitória, 29308-014, Brazil

Location

William Osler Health System

Brampton, Ontario, L6R 3J7, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Beijing Friendship Hospital Capital Medical University

Beijing, 100050, China

Location

Beijing Cancer Hospital Respiratory Medicine Department II

Beijing, 100142, China

Location

Beijing Cancer Hospital Respiratory Medicine Department I

Beijing, 100142, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

Beijing Chest hospital, Capital medical university

Beijing, 101149, China

Location

Jilin cancer hospital

Changchun, 130000, China

Location

Hunan Cancer hospital Thoracic Medicine Department II

Changsha, 410013, China

Location

Hunan Cancer hospital Thoracic Medicine Department I

Changsha, 410013, China

Location

The First People's Hospital Of Changzhou

Changzhou, 213003, China

Location

Sichuan Cancer Hospital

Chengdu, 610041, China

Location

West China Hospital Sichuan University

Chengdu, 610041, China

Location

Southwest Hospital

Chongqing, 400038, China

Location

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510080, China

Location

Sun Yat-Sen Memorial Hospital Sun Yat-sen University

Guangzhou, 510120, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, 310009, China

Location

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, 310009, China

Location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Harbin medical university cancer hospital

Harbin, 150000, China

Location

Huizhou Municipal Central Hospital

Huizhou, 516001, China

Location

Taizhou Hospital of Zhejiang Province

Linhai, 317000, China

Location

Nantong Tumor Hospital

Nantong, 226300, China

Location

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025, China

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Shanghai East Hospital

Shanghai, 200123, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110022, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Cancer Hospital of Xinjiang Medical University

Ürümqi, 830000, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China

Location

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

Wuhan, 430030, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061, China

Location

Yantai Yuhuangding Hospital

Yantai, 264000, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

Institut Bergonie

Bordeaux, 33000, France

Location

Hospices Civils de Lyon HCL

Bron, 69500, France

Location

CHU de Grenoble Hopital Albert Michallon

La Tronche, 38700, France

Location

Institute Coeur Poumon

Lille, 59000, France

Location

CHU de Limoges

Limoges, 87000, France

Location

Hopital Nord

Marseille, 13915, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital Tenon

Paris, 75970, France

Location

CHU Bordeaux

Pessac, 33604, France

Location

CHU Nantes

Sain-Herblain, 44800, France

Location

HIA Begin

Saint-Mandé, 94163, France

Location

CHU Bretonneau

Tours, 37000, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Zentralklinik Bad Berka GmbH

Bad Berka, 99437, Germany

Location

Helios Klinikum Emil von Behring GmbH

Berlin, 14165, Germany

Location

Kliniken der Stadt Koeln gGmbH

Cologne, 51109, Germany

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

Gauting, 82131, Germany

Location

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, 06120, Germany

Location

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Onkologische Schwerpunktpraxis

Heilbronn, 74072, Germany

Location

POIS Leipzig GbR

Leipzig, 04357, Germany

Location

Pius-Hospital Oldenburg

Oldenburg, 26121, Germany

Location

Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

Stuttgart, 70376, Germany

Location

Orszagos Koranyi Tbc es Pulmonologiai Intezet

Budapest, H-1529, Hungary

Location

Veszprém Megyei Tudőgyógyintézet

Farkasgyepü, 8582, Hungary

Location

Mátrai Gyógyintézet-Bronchológia

Gyöngyös, 3233, Hungary

Location

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, 8000, Hungary

Location

Markusovszky Egyetemi Oktatokorhaz

Szombathely, 9700, Hungary

Location

Tudogyogyintezet Torokbalint

Törökbálint, 2045, Hungary

Location

Basavatarakam Indo-American Hospital

Hyderabad, 500034, India

Location

Tata Medical Center

Kolkata, 700160, India

Location

Tata Memorial Hospital

Mumbai, 400012, India

Location

HCG Manavta Cancer Centre

Nashik, 422002, India

Location

Noble Hospital Pvt Ltd

Pune, 411013, India

Location

Rambam Health Corporation

Haifa, 3109601, Israel

Location

Hadassah Medical Center

Jerusalem, 9112001, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5262100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Ospedale San Giuseppe Moscati di Avellino

Avellino, 83100, Italy

Location

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

Catania, 95123, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

San Gerardo Hospital

Monza, 20052, Italy

Location

Ospedale Monaldi

Naples, 80100, Italy

Location

Aou San Luigi Gonzaga

Orbassano, 10043, Italy

Location

Ospedale S. Maria Delle Croci

Ravenna, 48121, Italy

Location

Irccs Gemelli

Roma, 00168, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Juntendo University Hospital

Bunkyō City, 113 8431, Japan

Location

National Cancer Center Hospital

Chūōku, 104 0045, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

Location

National Hospital Organization Himeji Medical Center

Himeji, 670-8520, Japan

Location

Kansai Medical University Hospital

Hirakata, 573 1191, Japan

Location

Kanazawa University Hospital

Kanazawa, 920 8641, Japan

Location

National Cancer Center Hospital East

Kashiwa, 277 8577, Japan

Location

Kurume University Hospital

Kurume, 830-0011, Japan

Location

Matsusaka Municipal Hospital

Matsusaka, 515-8544, Japan

Location

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

Location

Okayama University Hospital

Okayama, 700 8558, Japan

Location

Kindai University Hospital

Osaka Sayama Shi, 589 8511, Japan

Location

National Hospital Organization Shibukawa Medical Center

Shibukawa, 377-0280, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550, Japan

Location

National Hospital Organization Tokyo Medical Center

Tokyo, 152 8902, Japan

Location

Ehime University Hospital

Toon-shi, 791-0295, Japan

Location

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-shi, 560-8552, Japan

Location

Wakayama Medical University Hospital

Wakayama, 641 8510, Japan

Location

National Hospital Organization Iwakuni Clinical Center

Yamaguchi, 740-8510, Japan

Location

National Hospital Organization Yamaguchi Ube Medical Center

Yamaguchi, 755-0241, Japan

Location

Hospital Pulau Pinang

George Town, 10990, Malaysia

Location

Hospital Sultan Ismail

Johor Bahru, 81100, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

Location

Beacon Hospital Sdn Bhd

Petaling Jaya, 46050, Malaysia

Location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, 44280, Mexico

Location

CIMOVA, Morals Vargas Centro de Investigación SC

León, 37000, Mexico

Location

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

Mexico City, 03100, Mexico

Location

Médica Sur

Mexico City, 14050, Mexico

Location

Health Pharma Professional Research

México, 03100, Mexico

Location

Instituto Nacional de Cancerologia

México, 14080, Mexico

Location

i Can Oncology Center

Monterrey, 64710, Mexico

Location

Oncologia Integral Satelite

Naucalpan, 53100, Mexico

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Rijnstate Ziekenhuis

Arnhem, 6815 AD, Netherlands

Location

Ziekenhuis St Jansdal

Harderwijk, 3844 DG, Netherlands

Location

UMC Radboud

Nijmegen, 6525AG, Netherlands

Location

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, 85 796, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 214, Poland

Location

Szpitale Pomorskie Sp z o o

Gdynia, 81 519, Poland

Location

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, 10-357, Poland

Location

Private Specialist Hospitals - MedPolonia

Poznan, 60-693, Poland

Location

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

Uls Santa Maria - Hosp. Pulido Valente

Lisbon, 1769-001, Portugal

Location

Uls Santo Antonio - Hosp. Santo Antonio

Porto, 4099-001, Portugal

Location

Hosp. Cuf Porto

Porto, 4100 180, Portugal

Location

Instituto Portugues de Oncologia

Porto, 4200-072, Portugal

Location

Pan American Center for Oncology Trials LLC

Rio Piedras, 00935, Puerto Rico

Location

Irkutsk Regional Oncology Dispensary

Irkutsk, 664035, Russia

Location

Moscow City Oncology Hospital № 62

Krasnogorsk, 143423, Russia

Location

Krasnoyarsk Regional Oncology Dispensary

Krasnoyarsk, 660133, Russia

Location

Leningrad Regional Oncology Dispensary

Kuzmolovsky, 188663, Russia

Location

MCK

Moscow, 115533, Russia

Location

City Clinical Hospital #1

Nal'chik, 360000, Russia

Location

Nizhny Novgorod Regional Oncological Dispensary

Nizhny Novgorod, 603000, Russia

Location

Omsk Clinical Oncology Dispensary

Omsk, 664013, Russia

Location

Current medical technologies

Saint Petersburg, 190121, Russia

Location

Oncology Medical Clinics AV Medical group

Saint Petersburg, 196006, Russia

Location

N.N. Petrov Research Institute Of Oncology

Saint Petersburg, 197758, Russia

Location

Tambov Regional Oncology Clinical Dispansary

Tambov, 392013, Russia

Location

Tomsk Cancer Research Institute

Tomsk, 634050, Russia

Location

Bashkir State Medical University

Ufa, 450083, Russia

Location

Yaroslavl Regional Clinical Oncology Hospital

Yaroslavl, 150054, Russia

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, 28644, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591, South Korea

Location

Korea University Guro Hospital

Seoul, 8308, South Korea

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Inst. Cat. D'Oncologia-Badalona

Badalona, 08916, Spain

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hosp. Univ. Quiron Dexeus

Barcelona, 08028, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp. Univ. de Burgos

Burgos, 09003, Spain

Location

Institut Català D'Oncologia Girona

Girona, 17007, Spain

Location

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. La Paz

Madrid, 28046, Spain

Location

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, 28222, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29011, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

Hosp. Gral. Univ. Valencia

Valencia, 46014, Spain

Location

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, 50009, Spain

Location

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

E-DA Hospital

Kaohsiung City, 824, Taiwan

Location

Chang Gung Medical Foundation

Kaohsiung City, 833, Taiwan

Location

Taipei Medical University Shuang Ho Hospital

New Taipei City, 23561, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Phramongkutklao Hospital and Medical College

Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Chiang Mai University

Chiang Mai, 50200, Thailand

Location

Songklanagarind Hospital, Prince of Songkla University

Songkhla, 90110, Thailand

Location

Adana City Hospital

Adana, 01060, Turkey (Türkiye)

Location

Başkent University Medical Faculty Adana Application and Research Center

Adana, 01250, Turkey (Türkiye)

Location

Gazi Hastanesi

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital

Ankara, 6800, Turkey (Türkiye)

Location

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

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

Istanbul, 34098, Turkey (Türkiye)

Location

Medipol Mega University Hospital

Istanbul, 34214, Turkey (Türkiye)

Location

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

Istanbul, 34722, Turkey (Türkiye)

Location

Medical Point

Izmir, 35575, Turkey (Türkiye)

Location

Necmettin Erbakan University Meram Medical Faculty

Konya, 42080, Turkey (Türkiye)

Location

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

Dnipro, 49102, Ukraine

Location

Municipal non-profit enterprise 'Regional Center of Oncology'

Kharkiv, 61070, Ukraine

Location

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

Kyiv, 02091, Ukraine

Location

State Nonprofit Enterprise National Cancer Institute

Kyiv, 03022, Ukraine

Location

Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

Uzhhorod, 88000, Ukraine

Location

Edinburgh Cancer Centre Western General

Edinburgh, EH4 2XU, United Kingdom

Location

UCL Cancer Institute

London, NW1 2PG, United Kingdom

Location

Chelsea And Westminster Hospital

London, SW10 9NH, United Kingdom

Location

The Royal Marsden NHS Trust

London, SW3 6JJ, United Kingdom

Location

Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

The Royal Marsden NHS Trust 1

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 40923797 DERIVED

• 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.

  PMID: 38924756 DERIVED

• 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.

  PMID: 34911336 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

amivantamab; osimertinib; lazertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Global Medical Head Onc
• Organization: Janssen Research & Development

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only Arm B and C will be masked to all (Double-blind).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 27, 2020
• Study Start: September 30, 2020
• Primary Completion: August 11, 2023
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 22, 2026
• Results First Posted: October 9, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

PT (4); PL (6); AR (5); CN (34); PR (1); RU (15); NL (4); BR (16); JP (20); KR (9); IN (5); CA (4); HU (6); DE (11); BE (5); GB (7); FR (13); UA (5); US (20); TW (8); MY (6); ES (16); IT (13); AU (8); ME (8); IL (6); TU (10); TH (4)