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ACTIVE NOT RECRUITING
NCT04988295
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

776

Start Date

2021-11-17

Completion Date

2026-09-30

Last Updated

2026-02-05

Healthy Volunteers

No

Interventions

DRUG

Lazertinib

Lazertinib will be administered orally.

DRUG

Amivantamab

Amivantamab will be administered as an IV infusion.

DRUG

Pemetrexed

Pemetrexed will be administered as an IV infusion.

DRUG

Carboplatin

Carboplatin will be administered as an IV infusion.

Locations (247)

Southern Cancer Center, PC

Mobile, Alabama, United States

Arizona Oncology Associates

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

Fort Lauderdale, Florida, United States

University Cancer And Blood Center LLC

Athens, Georgia, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Nebraska Cancer Specialists

Grand Island, Nebraska, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

TriHealth Network

Cincinnati, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Kaiser Permanente Northwest

Portland, Oregon, United States

Alliance Cancer Specialists

Horsham, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Texas Oncology-Medical City Dallas

Dallas, Texas, United States

Texas Oncology Baylor Charles A Sammons Cancer Center

Dallas, Texas, United States

Texas Oncology

Grapevine, Texas, United States

Oncology Consultants Texas

Houston, Texas, United States

Texas Oncology - Northeast

Longview, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Blue Ridge Cancer Care

Wytheville, Virginia, United States

NorthWest Medical Specialties, PLLC

Puyallup, Washington, United States

Compass Oncology

Vancouver, Washington, United States

CINME Centro de Investigaciones Metabolicas

Caba, Argentina

IADT Instituto Argentino de Diagnostico y Tratamiento

CABA, Argentina

Centro Medico Fleischer

CABA, Argentina

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

CABA, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Hospital Privado Universitario De Cordoba

Córdoba, Argentina

Hospital Privado de la Comunidad

Mar del Plata, Argentina

Clínica Viedma

Viedma, Argentina

Grand Hopital De Charleroi Site Les Viviers

Charleroi, Belgium

UZA

Edegem, Belgium

UZ Gent

Ghent, Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Belgium

UZ Leuven

Leuven, Belgium

CHU Sart-Tilman

Liège, Belgium

Clinique Saint Pierre

Ottignies, Belgium

Cetus Oncologia

Belo Horizonte, Brazil

CIONC Centro Integrado de Oncologia de Curitiba

Curitiba, Brazil

Ynova Pesquisa Clinica

Florianópolis, Brazil

Fundacao Sao Francisco Xavier

Ipatinga, Brazil

UPCO Unidade de Pesquisa Clinica em Oncologia

Pelotas, Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Hospital Ernesto Dornelles

Porto Alegre, Brazil

Oncoclinicas Rio de Janeiro S A

Rio de Janeiro, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, Brazil

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

Rio de Janeiro, Brazil

Nucleo de Oncologia da Bahia

Salvador, Brazil

Hospital Sao Rafael

Salvador, Brazil

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, Brazil

Hospital Paulistano

São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Hospital Nove de Julho

São Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Onco Star SP Oncologia Ltda

São Paulo, Brazil

IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

Sorocaba, Brazil

COT - Centro Oncologico do Triangulo S.A

Uberlândia, Brazil

Multifunctional Hospital for Active Treatment 'Serdika'

Sofia, Bulgaria

Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

Sofia, Bulgaria

Specialized Hospital for Active Treatment in Oncology

Sofia, Bulgaria

UMHAT Sofia Med

Sofia, Bulgaria

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

Peking University People's Hospital

Beijing, China

Beijing Cancer Hospital

Beijing, China

Chinese PLA General Hospital

Beijing, China

Beijing Chest hospital, Capital medical university

Beijing, China

Hunan Cancer hospital

Changsha, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Southwest Hospital

Chongqing, China

Daping Hospital Army Characteristic Medical Center

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

Affiliated Hospital of North Sichuan Medical College

Nanchong, China

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanghai East Hospital

Shanghai, China

Shenzhen university General Hospital

Shenzhen, China

Cancer Hospital Chinese Academy of Medical Sciences

Shenzhen, China

Tianjin Medical University General Hospital

Tianjin, China

Weifang People's Hospital

Weifang, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Yantai Yuhuangding Hospital

Yantai, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni nemocnice Olomouc - I.P.Pavlova 6

Olomouc, Czechia

Vitkovicka nemocnice a.s.

Ostrava- Vitkovice, Czechia

Fakultni nemocnice Plzen

Pilsen, Czechia

Rigshospitalet

Copenhagen, Denmark

Institut Sainte Catherine

Avignon, France

Hospices Civils de Lyon HCL

Bron, France

CHU de Grenoble Hopital Albert Michallon

La Tronche, France

Centre Hospitalier du Mans

Le Mans, France

CHR Hôpital Calmette

Lille, France

Hopital Nord

Marseille, France

CHU de Montpellier - Arnaud de Villeneuve

Montpellier, France

Institut Curie

Paris, France

CHU Bordeaux

Pessac, France

CHRU Hopital de Pontchaillou

Rennes, France

CHU Nantes

Sain-Herblain, France

Nouvel Hopital Civil - CHU Strasbourg

Strasbourg, France

CHU Bretonneau

Tours, France

Evangelische Lungenklinik Berlin

Berlin, Germany

Asklepios Klinikum Harburg

Hamburg, Germany

Thoraxklinik am Universitatsklinikum Heidelberg

Heidelberg, Germany

Onkologische Schwerpunktpraxis

Heilbronn, Germany

POIS Sachsen GmbH iG

Leipzig, Germany

Bethanien Krankenhaus

Moers, Germany

Klinikum der Universitaet Muenchen

München, Germany

Oncologianova GmbH

Recklinghausen, Germany

Universitaetsklinikum Regensburg

Regensburg, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

Health Care Global Enterprises pvt Ltd

Bangalore, India

Artemis Hospital

Gurugram, India

Tata Medical Center

Kolkata, India

Tata Memorial Hospital

Mumbai, India

HCG Manavta Cancer Centre

Nashik, India

Rajiv Gandhi Cancer Institute and Research Centre

New Delh, India

Noble Hospital Pvt Ltd

Pune, India

Bhaktivedanta Hospital & Research Institute

Thane, India

Soroka University Medical Center

Beersheba, Israel

Rambam Health Corporation

Haifa, Israel

Shaare Zedek 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

CRO IRCCS Istituto Nazionale Tumori

Aviano, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

Istituto Europeo di Oncologia

Milan, Italy

Azienda Ospedaliero-Universitaria Di Parma

Parma, Italy

Ospedale S. Maria Delle Croci

Ravenna, Italy

Istituto Nazionale Tumori Regina Elena

Roma, Italy

Policlinico G.B.Rossi

Verona, Italy

National Hospital Organization Shibukawa Medical Center

Gunma, Japan

Hyogo Cancer Center

Hyōgo, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Kobe City Medical Center General Hospital

Kobe, Japan

Kurume University Hospital

Kurume, Japan

National Hospital Organization Nagoya Medical Center

Nagoya, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Osaka International Cancer Institute

Osaka, Japan

Shizuoka Cancer Center

Shizuoka, Japan

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Ehime University Hospital

Toon-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

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Beacon Hospital Sdn Bhd

Petaling Jaya, Malaysia

Subang Jaya Medical Centre

Subang Jaya, Malaysia

Mount Miriam Cancer Hospital

Tanjung Bungah, Malaysia

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Mexico

CIMOVA, Morals Vargas Centro de Investigación SC

León, Mexico

Health Pharma Professional Research

México, Mexico

Instituto Nacional de Cancerologia

México, Mexico

Oncologia Integral Satelite

Naucalpan, Mexico

VUMC Amsterdam

Amsterdam, Netherlands

Ziekenhuis St Jansdal

Harderwijk, Netherlands

Erasmus MC

Rotterdam, 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

Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow

Poznan, 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 Loures Odivelas - Hosp. Loures

Loures, Portugal

Uls Santo Antonio - Hosp. Santo Antonio

Porto, Portugal

Instituto Portugues de Oncologia

Porto, Portugal

Pan American Center for Oncology Trials LLC

Rio Piedras, Puerto Rico

City Clinical Hospital #1

Nal'chik, Russia

Llc, Eurocityclinic

Saint Petersburg, Russia

National Cancer Center

Gyeonggi-do, South Korea

CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

GyeongSang National University Hospital

Gyeongsangnam-do, South Korea

Korea University Anam 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

Hosp Univ A Coruna

A Coruña, 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 Clinic de Barcelona

Barcelona, Spain

Hosp. Univ. Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp Univ Fund Jimenez Diaz

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp Univ Hm Sanchinarro

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. Univ. I Politecni La Fe

Valencia, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Linkoping University Hospital

Linköping, Sweden

Skanes universitetssjukhus

Lund, Sweden

Norrlands Universitetssjukhus

Umeå, Sweden

Akademiska Sjukhuset

Uppsala, Sweden

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Taiwan

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Adana City Hospital

Adana, Turkey (Türkiye)

Memorial Ankara Hastanesi

Ankara, Turkey (Türkiye)

Gazi University Hospital

Ankara, Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Bakirkoy Training and Research Hospital

Istanbul, Turkey (Türkiye)

Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

Istanbul, Turkey (Türkiye)

Medical Point

Izmir, Turkey (Türkiye)

Velindre Hospital

Cardiff, United Kingdom

Edinburgh Cancer Centre Western General

Edinburgh, United Kingdom

UCL Cancer Institute

London, United Kingdom

Guys and St Thomas NHS Foundation Trust

London, United Kingdom

The Royal Marsden NHS Trust

London, United Kingdom

The Christie Nhs Foundation Trust

Manchester, United Kingdom