A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer

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Trial Details

Sponsor: Janssen Research & Development, LLC (industry)

Phase: 2

Start date: Nov. 11, 2022

Planned enrollment: 390

Last updated in HealthScout: Dec 2024

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Trial ID: NCT05498428
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More trial details at ClinicalTrials.gov More info

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Goal: The trial aims to evaluate the anti-tumor efficacy and safety profile of subcutaneous amivantamab, a monoclonal antibody against EGFR and MET, using a recombinant human hyaluronidase (rHuPH20) co-formulation across various dosing regimens in patients with advanced or metastatic solid tumors, including non-small cell lung cancer (NSCLC) with specific EGFR mutations. Additionally, it seeks to assess the safety of transitioning patients from amivantamab IV to its subcutaneous formulation.

Patients: The trial focuses on participants with locally advanced or metastatic NSCLC possessing specific EGFR mutations such as exon 19 deletions, exon 21 L858R substitutions, or exon 20 insertions. Patients are categorized into different cohorts based on prior treatment histories, including those who are treatment-naïve, post-osimertinib, or previously treated with amivantamab IV.

Design: This is a phase 2, open-label, non-randomized, parallel cohort study with a planned enrollment of 390 participants across multiple treatment arms. Each cohort follows a specific treatment regimen based on their EGFR mutation status and line of therapy.

Treatments: The study investigates amivantamab in subcutaneous co-formulation as a monotherapy and in combination with other agents, such as lazertinib and chemotherapeutics carboplatin and pemetrexed. Amivantamab is a bispecific fully human IgG1 antibody targeting EGFR and MET pathways, intended to inhibit tumor growth by blocking receptor signaling and mediating antibody-dependent cellular cytotoxicity. Previous trials have demonstrated efficacy in treatment-resistant NSCLC with manageable safety profiles. In certain cohorts, it is combined with lazertinib, another targeted therapy, to enhance therapeutic effects. Regimens are adjusted based on cohorts and previous therapies received.

Outcomes: Primary outcomes include objective response rate (ORR) for all cohorts except for those solely investigating safety in previously exposed patients, where adverse events are the primary focus. Secondary outcomes measure the duration of response (DoR), progression-free survival (PFS), overall survival (OS), and patient-reported satisfaction and quality of life assessments, specifically for patients transitioning from IV to subcutaneous administration.

Burden on patient: The trial places a moderate to high burden on patients due to frequent administration schedules, combination therapies, and regular clinical evaluations. Participants are subject to multiple cycles of treatment, each involving frequent clinic visits for drug administration, and routine imaging and laboratory assessments to monitor disease progression and side effects. Patients transitioning from IV to subcutaneous therapy might endure additional visits and questionnaires assessing treatment satisfaction.

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PERSONAL Oncologia de Precisao e Personalizada

Belo Horizonte, 30130 090, Brazil

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Fundacao Antonio Prudente A C Camargo Cancer Center

Sao Paulo, 01509 900, Brazil

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Impar Servicos Hospitalares SA Hospital Nove de Julho

Sao Paulo, 01409-001, Brazil

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Hospital Alemao Oswaldo Cruz

Sao Paulo, 01327 001, Brazil

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Instituto D Or de Pesquisa e Ensino IDOR

Salvador, 41253-190, Brazil

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Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, 22281 100, Brazil

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Associacao Hospitalar Moinhos de Vento

Porto Alegre, 90035-001, Brazil

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Instituto do Cancer de Londrina Hospital do Cancer de Londrina

Londrina, 86015, Brazil

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Fundacao Pio XII

Barretos, 14784-400, Brazil

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Huizhou Municipal Central Hospital

Huizhou, 516001, China

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Harbin medical university cancer hospital

Harbin, 150000, China

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Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, 310016, China

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The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, 310003, China

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The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510060, China

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The First Affiliated Hospital of PLA Army Medical University

ChongQing, 400038, China

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West China Hospital Sichuan University

Chengdu, 610047, China

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Sichuan Cancer Hospital

Chengdu, 610041, China

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Jilin cancer hospital

Changchun, 130000, China

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Affiliated Hospital of Hebei University

Bao Ding Shi, 071051, China

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Yantai Yuhuangding Hospital

Yantai, 264000, China

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The First Affiliated Hospital of Xian Jiaotong University

XI An, 710061, China

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Hospital of Jiangnan University

Wuxi, 214122, China

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Status: Completed

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

Wuhan, 430022, China

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The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China

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Tianjin Medical University General Hospital

Tianjin, 300052, China

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Fudan University Shanghai Cancer Center

Shanghai, 200032, China

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Liuzhou people's Hospital

Liuzhou, 545006, China

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Status: Completed

Institut de Cancérologie du Gard

Nîmes, 30029, France

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Status: Recruiting

Centre Francois Baclesse

Caen Cedex 05, 14076, France

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Centre Georges-François Leclerc

Dijon, 21079, France

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Status: Completed

Institut Curie

PARIS Cedex 5, 75248, France

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Institut de cancerologie de l'ouest

Saint-Herblain Cedex, 44805, France

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Gustave Roussy

Villejuif Cedex, 94800, France

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Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

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LungenClinic Grosshansdorf GmbH

Grosshandorf, 22927, Germany

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Klinikum Würzburg Mitte gGmbH Standort Missioklinik

Wuerzburg, 97074, Germany

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Evangelische Lungenklinik Berlin

Berlin, 13125, Germany

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Universitaetsklinikum Koelnt

Koeln, 50937, Germany

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Status: Recruiting

Sheba Medical Center

Ramat Gan, 52621, Israel

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Rabin Medical Center

Petah Tikva, 4941492, Israel

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Meir Medical Center

Kfar Saba, 44281, Israel

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Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

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Rambam Medical Center

Haifa, 3109601, Israel

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Policlinico Hospital San Martino- IRCCS for Oncology

Genova, 16132, Italy

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Ospedale San Raffaele

Milano, 20132, Italy

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ASST Grande Ospedale Metropolitano Niguarda

Milano, 20162, Italy

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Azienda Ospedaliera San Gerardo

Monza, 20090, Italy

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Azienda Ospedaliera Specialistica dei Colli

Naples, 80131, Italy

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Matsusaka Municipal Hospital

Matsusaka, 515-8544, Japan

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Status: ACTIVE_NOT_RECRUITING

Niigata Cancer Center Hospital

Niigata, 951-8566, Japan

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Status: ACTIVE_NOT_RECRUITING

Shizuoka Cancer Center

Shizuoka, 411 8777, Japan

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Status: ACTIVE_NOT_RECRUITING

Wakayama Medical University Hospital

Wakayama, 641 8510, Japan

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Status: ACTIVE_NOT_RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550, Japan

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Status: ACTIVE_NOT_RECRUITING

National Hospital Organization Himeji Medical Center

Himeji, 670-8520, Japan

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Seoul National University Bundang Hospital

Seongnam-si, 13620, Korea, Republic of

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Status: Recruiting

Severance Hospital Yonsei University Health System

Seoul, 03722, Korea, Republic of

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Seoul National University Hospital

Seoul, 03080, Korea, Republic of

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Asan Medical Center

Seoul, 05505, Korea, Republic of

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National Cancer Center

Goyang-Si, 10408, Korea, Republic of

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Beacon Hospital Sdn Bhd

Petaling Jaya, 46050, Malaysia

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Hospital Umum Sarawak

Kuching, 93586, Malaysia

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Hospital Tengku Ampuan Afzan

Kuantan, 25100, Malaysia

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University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

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Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

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Hosp Univ A Coruna

A Coruña, 15006, Spain

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General University Hospital of Alicantet

Alacant, 03010, Spain

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Hosp. Del Mar

Barcelona, 08003, Spain

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Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

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Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

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Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, 8908, Spain

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Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

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Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

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Hosp. Univ. La Paz

Madrid, 28046, Spain

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Hosp Regional Univ de Malaga

Malaga, 29010, Spain

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Hosp. Virgen Macarena

Sevilla, 41009, Spain

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Hosp. Clinico Univ. de Valencia

Valencia, 46010, Spain

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Hosp. Gral. Univ. Valencia

Valencia, 46014, Spain

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Torbay Hospital-Devon

Devon, TQ2 7AA, United Kingdom

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Cheltenham General Hospital

Cheltenham, GL53 7AN, United Kingdom

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Status: Completed

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

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Status: Recruiting

Nottingham City Hospital

Nottingham, NG5 1PB, United Kingdom

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University College London Hospitals

London, NW1 2PG, United Kingdom

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Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

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Edinburgh Cancer Centre Western General

Edinburgh, EH4 2XU, United Kingdom

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University of California at San Diego

La Jolla, California, 92093, United States

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Stanford Cancer Institute

Stanford, California, 94305, United States

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University of California Irvine

Orange, California, 92868, United States

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Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

Washington, District of Columbia, 20016, United States

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Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

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AdventHealth

Orlando, Florida, 32804, United States

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H. Lee Moffitt Cancer & Research Institute

Tampa, Florida, 33612, United States

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Baptist Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

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Status: Completed

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

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Status: Recruiting

Sidney Kimmel Cancer Center - Bayview Campus

Baltimore, Maryland, 21224, United States

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Boston Medical Center

Boston, Massachusetts, 02118, United States

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Washington University School Of Medicine

Saint Louis, Missouri, 63110, United States

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Status: Recruiting

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

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Status: Recruiting

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

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Hematology-Oncology Associates of CNY

East Syracuse, New York, 13057, United States

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Status: Completed

Novant Health

Charlotte, North Carolina, 28204, United States

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Status: Recruiting

Novant Health

Winston-Salem, North Carolina, 27106, United States

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Cleveland Clinic

Warrensville Heights, Ohio, 44122, United States

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Status: Completed

Cleveland Clinic

Mayfield Heights, Ohio, 44124, United States

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Status: Completed

Cleveland Clinic

Cleveland, Ohio, 44195, United States

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Status: Completed

Cleveland Clinic

Cleveland, Ohio, 44111, United States

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Status: Completed

The Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

No email / No phone

Status: Completed

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Recruiting

Swedish Cancer Institute

Seattle, Washington, 98104, United States

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Providence Regional Cancer Partnership

Everett, Washington, 98201, United States

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Status: Completed

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

No email / No phone

Status: Completed

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