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

NCT ID: NCT04487080

Last Updated: 2025-11-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1074 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2027-06-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Participants will receive amivantamab 1050 milligram (mg) intravenously (IV) for body weight less than (\<) 80 kilogram (kg) and 1400 mg for body weight greater than or equal to (\>=) 80 kg in 28-day cycles: once weekly in Cycle 1 (with a split dose on Days 1-2), and then every 2 weeks in subsequent cycles. Lazertinib will be administered 240 mg (80\*3) orally once daily.

Group Type: EXPERIMENTAL

Amivantamab

Intervention Type: DRUG

Participants will receive amivantamab intravenously.

Lazertinib

Intervention Type: DRUG

Participants will receive lazertinib tablets orally.

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

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

Group Type: ACTIVE_COMPARATOR

Osimertinib

Intervention Type: DRUG

Participants will receive osimertinib capsules orally.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo orally.

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

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

Group Type: EXPERIMENTAL

Lazertinib

Intervention Type: DRUG

Participants will receive lazertinib tablets orally.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo orally.

Interventions

Amivantamab

Participants will receive amivantamab intravenously.

Intervention Type: DRUG

Osimertinib

Participants will receive osimertinib capsules orally.

Intervention Type: DRUG

Lazertinib

Participants will receive lazertinib tablets orally.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo orally.

Intervention Type: DRUG

Other Intervention Names

JNJ-61186372; JNJ-73841937 and YH-25448

Eligibility Criteria

Inclusion Criteria

• Participant must have newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation
• The tumor harbors exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by an food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care
• Mandatory submission of unstained tissue from tumor (in a quantity sufficient to allow for central analysis of EGFR mutation status and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis)
• Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level
• Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy

Exclusion Criteria

• Participant has received any prior systemic treatment at any time for locally advanced Stage III or metastatic Stage IV disease (adjuvant or neoadjuvant therapy for Stage I or II disease is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease)
• Participant has an active or past medical history of leptomeningeal disease
• Participant with untreated spinal cord compression. A participant that has been definitively treated with surgery or radiation and has a stable neurological status for at least 2 weeks prior to randomization is eligible provided they are off corticosteroid treatment or receiving low-dose corticosteroid treatment less than or equal to (<=) 10 milligrams per day (mg/day) prednisone or equivalent
• Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis
• Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib
• Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Arizona Oncology Associates, PC - HAL

Goodyear, Arizona, United States

Yuma Regional Medical Center

Yuma, Arizona, United States

City of Hope Long Beach Elm

Long Beach, California, United States

University of California Irvine

Orange, California, United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

Cancer Specialists of North Florida

Jacksonville, Florida, United States

University Cancer And Blood Center LLC

Athens, Georgia, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

Maryland Oncology Hematology, PA

Columbia, Maryland, United States

Henry Ford Hospital

Detroit, Michigan, United States

Minnesota Oncology Hematology P A

Edina, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Texas Oncology P A

Austin, Texas, United States

Oncology Consultants Texas

Houston, Texas, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Centro Oncológico Korben

Buenos Aires, , Argentina

Instituto Alexander Fleming

Buenos Aires, , Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, , Argentina

Centro Oncologico Riojano Integral (Cori)

La Rioja, , Argentina

Clínica Viedma

Viedma, , Argentina

Flinders Medical Centre

Bedford Park, , Australia

Austin Hospital

Heidelberg, , Australia

Cabrini Medical Centre

Malvern, , Australia

St John of God Hospital Murdoch

Murdoch, , Australia

Sir Charles Gairdner Hospital

Nedlands, , Australia

Westmead Hospital

Westmead, , Australia

Southern Medical Day Care Centre

Wollongong, , Australia

Princess Alexandra Hospital

Woolloongabba, , Australia

Cliniques Universitaires Saint Luc

Brussels, , Belgium

Grand Hopital De Charleroi Site Les Viviers

Charleroi, , Belgium

UZ Leuven

Leuven, , Belgium

Clinique Saint Pierre

Ottignies, , Belgium

Algemeen Ziekenhuis Delta

Roeselare, , Belgium

Fundacao Pio XII

Barretos, , Brazil

Cetus Oncologia

Belo Horizonte, , Brazil

Ynova Pesquisa Clinica

Florianópolis, , Brazil

Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

Ijuí, , Brazil

Liga Norte Riograndense Contra O Cancer

Natal, , Brazil

UPCO Unidade de Pesquisa Clinica em Oncologia

Pelotas, , Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, , Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, , Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, , Brazil

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, , Brazil

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

São Paulo, , Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, , Brazil

Núcleo de Pesquisa São Camilo

São Paulo, , Brazil

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Sorocaba, , Brazil

Hospital Evangélico de Cachoeiro de Itapemirim

Vitória, , Brazil

William Osler Health System

Brampton, Ontario, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Beijing Friendship Hospital Capital Medical University

Beijing, , China

Beijing Cancer Hospital

Beijing, , China

Chinese PLA General Hospital

Beijing, , China

Beijing Chest hospital, Capital medical university

Beijing, , China

Jilin cancer hospital

Changchun, , China

Hunan Cancer hospital

Changsha, , China

The First People's Hospital Of Changzhou

Changzhou, , China

Sichuan Cancer Hospital

Chengdu, , China

West China Hospital Sichuan University

Chengdu, , China

Southwest Hospital

Chongqing, , China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, , China

Sun Yat-Sen Memorial Hospital Sun Yat-sen University

Guangzhou, , China

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, , China

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, , China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, , China

Zhejiang Cancer Hospital

Hangzhou, , China

Harbin medical university cancer hospital

Harbin, , China

Huizhou Municipal Central Hospital

Huizhou, , China

Taizhou Hospital of Zhejiang Province

Linhai, , China

Nantong Tumor Hospital

Nantong, , China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, , China

Shanghai Chest Hospital

Shanghai, , China

Fudan University Shanghai Cancer Center

Shanghai, , China

Shanghai East Hospital

Shanghai, , China

Shengjing Hospital Of China Medical University

Shenyang, , China

Tianjin Medical University General Hospital

Tianjin, , China

Cancer Hospital of Xinjiang Medical University

Ürümqi, , China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

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

Wuhan, , China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, , China

Yantai Yuhuangding Hospital

Yantai, , China

Henan Cancer Hospital

Zhengzhou, , China

Institut Bergonie

Bordeaux, , France

Hospices Civils de Lyon HCL

Bron, , France

CHU de Grenoble Hopital Albert Michallon

La Tronche, , France

Institute Coeur Poumon

Lille, , France

CHU de Limoges

Limoges, , France

Hopital Nord

Marseille, , France

Institut Curie

Paris, , France

Hopital Tenon

Paris, , France

CHU Bordeaux

Pessac, , France

CHU Nantes

Sain-Herblain, , France

HIA Begin

Saint-Mandé, , France

CHU Bretonneau

Tours, , France

Institut Gustave Roussy

Villejuif, , France

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Helios Klinikum Emil von Behring GmbH

Berlin, , Germany

Kliniken der Stadt Koeln gGmbH

Cologne, , Germany

Universitaetsklinikum Essen

Essen, , Germany

Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken Munchen-Gauting

Gauting, , Germany

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

Halle, , Germany

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, , Germany

Onkologische Schwerpunktpraxis

Heilbronn, , Germany

POIS Leipzig GbR

Leipzig, , Germany

Pius-Hospital Oldenburg

Oldenburg, , Germany

Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

Stuttgart, , Germany

Orszagos Koranyi Tbc es Pulmonologiai Intezet

Budapest, , Hungary

Veszprém Megyei Tudőgyógyintézet

Farkasgyepü, , Hungary

Mátrai Gyógyintézet-Bronchológia

Gyöngyös, , Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, , Hungary

Markusovszky Egyetemi Oktatokorhaz

Szombathely, , Hungary

Tudogyogyintezet Torokbalint

Törökbálint, , Hungary

Basavatarakam Indo-American Hospital

Hyderabad, , India

Tata Medical Center

Kolkata, , India

Tata Memorial Hospital

Mumbai, , India

HCG Manavta Cancer Centre

Nashik, , India

Noble Hospital Pvt Ltd

Pune, , India

Rambam Health Corporation

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Rabin Medical Center

Petah Tikva, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Ospedale San Giuseppe Moscati di Avellino

Avellino, , Italy

Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

Catania, , Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, , Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

IRCCS Ospedale San Raffaele

Milan, , Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Istituto Europeo di Oncologia

Milan, , Italy

San Gerardo Hospital

Monza, , Italy

Ospedale Monaldi

Napoli, , Italy

Aou San Luigi Gonzaga

Orbassano, , Italy

Ospedale S. Maria Delle Croci

Ravenna, , Italy

Irccs Gemelli

Roma, , Italy

Istituto Clinico Humanitas

Rozzano, , Italy

Juntendo University Hospital

Bunkyō City, , Japan

National Cancer Center Hospital

Chūōku, , Japan

National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

National Hospital Organization Himeji Medical Center

Himeji, , Japan

Kansai Medical University Hospital

Hirakata, , Japan

Kanazawa University Hospital

Kanazawa, , Japan

National Cancer Center Hospital East

Kashiwa, , Japan

Kurume University Hospital

Kurume, , Japan

Matsusaka Municipal Hospital

Matsusaka, , Japan

Niigata Cancer Center Hospital

Niigata, , Japan

Okayama University Hospital

Okayama, , Japan

Kindai University Hospital

Osaka Sayama Shi, , Japan

National Hospital Organization Shibukawa Medical Center

Shibukawa, , Japan

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

National Hospital Organization Tokyo Medical Center

Tokyo, , Japan

Ehime University Hospital

Toon-shi, , Japan

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-shi, , Japan

Wakayama Medical University Hospital

Wakayama, , Japan

National Hospital Organization Iwakuni Clinical Center

Yamaguchi, , Japan

National Hospital Organization Yamaguchi Ube Medical Center

Yamaguchi, , Japan

Hospital Pulau Pinang

George Town, , Malaysia

Hospital Sultan Ismail

Johor Bahru, , Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, , Malaysia

Beacon Hospital Sdn Bhd

Petaling Jaya, , Malaysia

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, , Mexico

CIMOVA, Morals Vargas Centro de Investigación SC

León, , Mexico

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

Mexico City, , Mexico

Médica Sur

Mexico City, , Mexico

Health Pharma Professional Research

México, , Mexico

Instituto Nacional de Cancerologia

México, , Mexico

i Can Oncology Center

Monterrey, , Mexico

Oncologia Integral Satelite

Naucalpan, , Mexico

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Rijnstate Ziekenhuis

Arnhem, , Netherlands

Ziekenhuis St Jansdal

Harderwijk, , Netherlands

UMC Radboud

Nijmegen, , Netherlands

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, , Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Szpitale Pomorskie Sp z o o

Gdynia, , Poland

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, , Poland

Private Specialist Hospitals - MedPolonia

Poznan, , Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, , Poland

Uls Santa Maria - Hosp. Pulido Valente

Lisbon, , Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, , Portugal

Hosp. Cuf Porto

Porto, , Portugal

Instituto Portugues de Oncologia

Porto, , Portugal

Pan American Center for Oncology Trials LLC

Rio Piedras, , Puerto Rico

Irkutsk Regional Oncology Dispensary

Irkutsk, , Russia

Moscow City Oncology Hospital № 62

Krasnogorsk, , Russia

Krasnoyarsk Regional Oncology Dispensary

Krasnoyarsk, , Russia

Leningrad Regional Oncology Dispensary

Kuzmolovsky, , Russia

MCK

Moscow, , Russia

City Clinical Hospital #1

Nal'chik, , Russia

Nizhny Novgorod Regional Oncological Dispensary

Nizhny Novgorod, , Russia

Omsk Clinical Oncology Dispensary

Omsk, , Russia

Current medical technologies

Saint Petersburg, , Russia

Oncology Medical Clinics AV Medical group

Saint Petersburg, , Russia

N.N. Petrov Research Institute Of Oncology

Saint Petersburg, , Russia

Tambov Regional Oncology Clinical Dispansary

Tambov, , Russia

Tomsk Cancer Research Institute

Tomsk, , Russia

Bashkir State Medical University

Ufa, , Russia

Yaroslavl Regional Clinical Oncology Hospital

Yaroslavl, , Russia

Inje University Haeundae Paik Hospital

Busan, , South Korea

Chungbuk National University Hospital

Cheongju-si, , South Korea

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Kangbuk Samsung Hospital

Seoul, , South Korea

Severance Hospital Yonsei University Health System

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Hosp Univ A Coruna

A Coruña, , Spain

Inst. Cat. D'Oncologia-Badalona

Badalona, , Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, , Spain

Hosp. Univ. Quiron Dexeus

Barcelona, , Spain

Hosp Univ Vall D Hebron

Barcelona, , Spain

Hosp. Univ. de Burgos

Burgos, , Spain

Institut Català D'Oncologia Girona

Girona, , Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. La Paz

Madrid, , Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, , Spain

Hosp Regional Univ de Malaga

Málaga, , Spain

Clinica Univ. de Navarra

Pamplona, , Spain

Hosp. Virgen Del Rocio

Seville, , Spain

Hosp. Gral. Univ. Valencia

Valencia, , Spain

Hosp. Clinico Univ. Lozano Blesa

Zaragoza, , Spain

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, , Taiwan

E-DA Hospital

Kaohsiung City, , Taiwan

Chang Gung Medical Foundation

Kaohsiung City, , Taiwan

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Chung Shan Medical University Hospital

Taichung, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Phramongkutklao Hospital and Medical College

Bangkok, , Thailand

Siriraj Hospital

Bangkok, , Thailand

Chiang Mai University

Chiang Mai, , Thailand

Songklanagarind Hospital, Prince of Songkla University

Songkhla, , Thailand

Adana City Hospital

Adana, , Turkey (Türkiye)

Başkent University Medical Faculty Adana Application and Research Center

Adana, , Turkey (Türkiye)

Gazi University Hospital

Ankara, , Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

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

Istanbul, , Turkey (Türkiye)

Medipol Mega University Hospital

Istanbul, , Turkey (Türkiye)

T C Saglik Bakanlıgi Goztepe Prof Dr Suleyman Yalcın Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

Medical Point

Izmir, , Turkey (Türkiye)

Necmettin Erbakan University Meram Medical Faculty

Konya, , Turkey (Türkiye)

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

Dnipro, , Ukraine

Municipal non-profit enterprise 'Regional Center of Oncology'

Kharkiv, , Ukraine

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

Kyiv, , Ukraine

National Cancer Institute

Kyiv, , Ukraine

Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

Uzhhorod, , Ukraine

Edinburgh Cancer Centre Western General

Edinburgh, , United Kingdom

UCL Cancer Institute

London, , United Kingdom

Chelsea And Westminster Hospital

London, , United Kingdom

The Royal Marsden NHS Trust

London, , United Kingdom

Christie NHS Foundation Trust

Manchester, , United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

The Royal Marsden NHS Trust

Sutton, , United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; China; France; Germany; Hungary; India; Israel; Italy; Japan; Malaysia; Mexico; Netherlands; Poland; Portugal; Puerto Rico; Russia; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40923797 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38924756 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34911336 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

73841937NSC3003

Identifier Type: OTHER

Identifier Source: secondary_id

2020-000743-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506576-27-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108856

Identifier Type: -

Identifier Source: org_study_id