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ACTIVE NOT RECRUITING
NCT05388669
PHASE3

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of the study is to simplify amivantamab intravenous administration and to reduce dose times, by assessing a new formulation of amivantamab, amivantamab subcutaneous and co-formulated with recombinant human hyaluronidase (SC-CF), for subcutaneous administration. This formulation has the potential to enhance both the patient and physician experience with amivantamab by providing easier and accelerated administration.

Official title: A Phase 3, Open-label, Randomized Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Patients With EGFR-mutated Advanced or Metastatic Non-small Cell Lung Cancer After Progression on Osimertinib and Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

418

Start Date

2022-08-05

Completion Date

2027-06-30

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Lazertinib

Lazertinib tablets will be administered orally.

DRUG

Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)

Amivantamab injection will be administered subcutaneously by manual injection.

DRUG

Amivantamab Intravenous

Amivantamab will be administered by IV infusion.

Locations (187)

City of Hope Duarte

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

City of Hope Long Beach Elm

Long Beach, California, United States

National Jewish Health

Denver, Colorado, United States

Baptist Lynn Cancer Institute

Boca Raton, Florida, United States

Orlando Health

Orlando, Florida, United States

University of Kansas

Kansas City, Kansas, United States

University of Michigan

Ann Arbor, Michigan, United States

Astera Cancer Care

East Brunswick, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Oncology and Hematology Care Clinic Westside

Portland, Oregon, United States

University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Buenos Aires, Argentina

IADT Instituto Argentino de Diagnostico y Tratamiento

CABA, Argentina

Centro Oncológico Korben

Chabas, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Sanatorio Allende

Córdoba, Argentina

Clínica Viedma

Viedma, Argentina

Cancer Research SA

Adelaide, Australia

Chris O'Brien Lifehouse

Camperdown, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

St John of God Hospital Murdoch

Murdoch, Australia

Westmead Hospital

Westmead, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Fundacao Pio XII

Barretos, Brazil

Cetus Oncologia

Belo Horizonte, Brazil

Instituto Cionc de Ensino e Pesquisa S/S

Curitiba, Brazil

Ynova Pesquisa Clinica

Florianópolis, Brazil

Fundacao Sao Francisco Xavier HMC Unidade de Oncologia

Ipatinga, Brazil

UPCO Unidade de Pesquisa Clinica em Oncologia

Pelotas, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Impar Servicos Hospitalares S/A

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

Nucleo de Oncologia da Bahia

Salvador, Brazil

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, Brazil

Impar Servicos Hospitalares SA Hospital Nove de Julho

São Paulo, Brazil

Núcleo de Pesquisa São Camilo

São Paulo, Brazil

Onco Star SP Oncologia Ltda

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Beijing Shijitan Hospital, Capital Medical University

Beijing, China

Beijing Friendship Hospital Capital Medical University

Beijing, China

Peking University Third Hospital

Beijing, China

Beijing Chest hospital, Capital medical university

Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Jilin cancer hospital

Changchun, China

The First People's Hospital Of Changzhou

Changzhou, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital Sichuan University

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Southwest Hospital

Chongqing, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, China

Sun Yat-Sen Memorial Hospital Sun Yat-sen University

Guangzhou, China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 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

Huizhou First Hospital

Huizhou, China

Liuzhou people's Hospital

Liuzhou, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shengjing Hospital Of China Medical University

Shenyang, China

Shenzhen People s Hospital

Shenzhen, China

Shenzhen university General Hospital

Shenzhen, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Union Hospital Tongji Medical College of Huazhong University of Science and Technology

Wuhan, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Xiangyang Central Hospital

Xiangyang, China

Yantai Yuhuangding Hospital

Yantai, China

Henan Cancer Hospital

Zhengzhou, China

CHU Grenoble

La Tronche, France

Institute Coeur Poumon

Lille, France

CHU de Limoges Hopital Dupuytren

Limoges, France

Hopital Nord

Marseille, France

Evangelische Lungenklinik Berlin

Berlin, Germany

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg

Georgsmarienhütte, Germany

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, Germany

Munster University Hospital

Münster, Germany

Oncologianova GmbH

Recklinghausen, Germany

Onkologische Schwerpunktpraxis

Weinsberg, Germany

Rambam Medical Center

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Shaare Zedek Medical Center

Yeruham, Israel

Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II

Bari, Italy

A O U Sant Orsola Malpighi

Bologna, Italy

European Institute of Oncology

Milan, Italy

Aou San Luigi Gonzaga

Orbassano, Italy

Istituto Oncologico Veneto - IRCCS

Padova, Italy

Ospedale S. Maria Delle Croci

Ravenna, Italy

And 87 more locations on ClinicalTrials.gov