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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

2026-03-16

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

Centro Oncológico Korben

Buenos Aires, Argentina

IADT Instituto Argentino de Diagnostico y Tratamiento

CABA, 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

Liuchow, 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

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

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

A.O. San Camillo Forlanini

Roma, Italy

Istituto Nazionale Tumori Regina Elena

Rome, Italy

Istituto Clinico Humanitas

Rozzano, Italy

National Cancer Center Hospital

Chūōku, Japan

National Hospital Organization Himeji Medical Center

Himeji, Japan

Kansai Medical University Hospital

Hirakata, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Kurashiki Central Hospital

Kurashiki, Japan

Kurume University Hospital

Kurume, Japan

Matsusaka Municipal Hospital

Matsusaka, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Okayama University Hospital

Okayama, Japan

Osaka International Cancer Institute

Osaka, Japan

Hokkaido University Hospital

Sapporo, Japan

Shizuoka Cancer Center

Shizuoka, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Fujita Health University Hospital

Toyoake, 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

Prince Court Medical Centre

Kuala Lumpur, Malaysia

Pantai Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Beacon Hospital Sdn Bhd

Petaling Jaya, Malaysia

Sunway Medical Centre

Petaling Jaya, Malaysia

Centrum Onkologii im Prof F Lukaszczyka w Bydgoszczy

Bydgoszcz, Poland

Krakowski Szpital Specjalityczny im. Jana Pawla II

Krakow, Poland

Mazowieckie Centrum Leczenia Chorob Pluc

Otwock, Poland

Private Specialist Hospitals - MedPolonia

Poznan, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Hospital de Braga

Braga, Portugal

Hospital da Luz, SA

Lisbon, Portugal

Hosp. Cuf Descobertas

Lisbon, Portugal

Ulsm - Hosp. Pedro Hispano

Senhora da Hora, Portugal

National Cancer Center

Gyeonggi-do, South Korea

CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea

GyeongSang National University Hospital

Gyeongsangnam-do, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Seoul National University 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

Hosp Univ A Coruna

A Coruña, Spain

Hosp. Gral. Univ. de Alicante

Alicante, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp. Univ. Quiron Dexeus

Barcelona, Spain

Hosp Reina Sofia

Córdoba, Spain

Hosp. Univ. Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Hosp. Univ. Lucus Augusti

Lugo, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Majadahonda, Spain

Hosp Regional Univ de Malaga

Málaga, Spain

Hosp. Univ. Central de Asturias

Oviedo, Spain

Hosp. Univ. Son Espases

Palma de Mallorca, Spain

Hosp. Virgen Del Rocio

Seville, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Taiwan

Chang Kung Memorial Hospital

Kaohsiung City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

National Taiwan University Cancer Center

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Phramongkutklao Hospital and Medical College

Bangkok, Thailand

Siriraj Hospital

Bangkok, Thailand

Chiang Mai University

Chiang Mai, Thailand

Adana City Hospital

Adana, Turkey (Türkiye)

Adana Baskent 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)

Acıbadem Maslak Hospital

Istanbul, Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, Turkey (Türkiye)

IEU Medical Point Hospital

Izmir, Turkey (Türkiye)

Medical Park Samsun Hastanesi

Samsun, Turkey (Türkiye)

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Imperial College Healthcare

London, United Kingdom

Newcastle Freeman Hospital

Newcastle upon Tyne, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom