RecruitingPhase 2NCT05498428

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

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

Sponsor

Janssen Research & Development, LLC

Enrollment

520 participants

Start Date

Nov 11, 2022

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing amivantamab, a targeted drug that attacks lung cancer cells with specific EGFR gene mutations. It is being studied in multiple groups of patients — including those newly diagnosed and those whose cancer has come back after prior treatment. **You may be eligible if...** - You are 18 or older with advanced non-small cell lung cancer (NSCLC) that cannot be cured with surgery or radiation - Your cancer has a specific EGFR gene mutation (such as exon 19 deletion, L858R, or exon 20 insertion) - Depending on the group, you may need to be treatment-naive or have progressed after specific prior therapies **You may NOT be eligible if...** - Your cancer does not have a qualifying EGFR mutation - Your general health or organ function does not meet study requirements - You have had prior treatments that are not allowed for your specific cohort Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmivantamab

Amivantamab will be administered subcutaneously by manual injection.

DRUGLazertinib

Lazertinib will be administered as an oral tablet.

DRUGCarboplatin

Carboplatin will be administrated by IV infusion.

DRUGPemetrexed

Pemetrexed will be administered by IV infusion.

DRUGDirect Oral Anticoagulant (DOAC)

DOAC will be administered orally.

DRUGLow Molecular Weight Heparin (LMWH)

LMWH will be administered subcutaneously.

Locations(110)

University of California at San Diego

La Jolla, California, United States

University of California Irvine

Orange, California, United States

Stanford Cancer Institute

Stanford, California, United States

Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Baptist Lynn Cancer Institute

Boca Raton, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth

Orlando, Florida, United States

H. Lee Moffitt Cancer & Research Institute

Tampa, Florida, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Sidney Kimmel Cancer Center - Bayview Campus

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Hematology-Oncology Associates of CNY

East Syracuse, New York, United States

Novant Health 1

Charlotte, North Carolina, United States

Novant Health

Winston-Salem, North Carolina, United States

Cleveland Clinic 1

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Cleveland Clinic 2

Mayfield Heights, Ohio, United States

Cleveland Clinic 3

Warrensville Heights, Ohio, United States

The Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Providence Regional Cancer Partnership

Everett, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Swedish Cancer Institute

Seattle, Washington, United States

Fundacao Pio XII

Barretos, Brazil

PERSONAL Oncologia de Precisao e Personalizada

Belo Horizonte, Brazil

Instituto do Cancer de Londrina Hospital do Cancer de Londrina

Londrina, Brazil

Associacao Hospitalar Moinhos de Vento

Porto Alegre, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

Rio de Janeiro, Brazil

Instituto D Or de Pesquisa e Ensino IDOR 1

Salvador, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Impar Servicos Hospitalares SA Hospital Nove de Julho

São Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Affiliated Hospital of Hebei University

Baoding, China

Jilin cancer hospital

Changchun, China

Sichuan Cancer Hospital

Chengdu, China

West China Hospital Sichuan University

Chengdu, China

The First Affiliated Hospital of PLA Army Medical University

Chongqing, China

The First Affiliated Hospital Sun Yat sen University

Guangzhou, China

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, China

Harbin medical university cancer hospital

Harbin, China

Huizhou Municipal Central Hospital

Huizhou, China

Liuzhou people's Hospital

Liuzhou, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Medical University General Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

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

Wuhan, China

Hospital of Jiangnan University

Wuxi, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Yantai Yuhuangding Hospital

Yantai, China

Centre Francois Baclesse

Caen, France

Centre Georges-François Leclerc

Dijon, France

Institut de Cancérologie du Gard

Nîmes, France

Institut Curie

Paris, France

Institut de cancerologie de l'ouest

Saint-Herblain, France

Gustave Roussy

Villejuif, France

Evangelische Lungenklinik Berlin

Berlin, Germany

Universitaetsklinikum Koelnt

Cologne, Germany

LungenClinic Grosshansdorf GmbH

Grosshandorf, Germany

Lungenfachklinik Immenhausen

Immenhausen, Germany

Klinikum Würzburg Mitte gGmbH Standort Missioklinik

Würzburg, Germany

Rambam Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Policlinico Hospital San Martino- IRCCS for Oncology

Genova, Italy

Ospedale San Raffaele

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Azienda Ospedaliera San Gerardo

Monza, Italy

Azienda Ospedaliera Specialistica dei Colli

Naples, Italy

National Hospital Organization Himeji Medical Center

Himeji, Japan

Saiseikai Matsusaka Municipal Hospital

Matsusaka, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Shizuoka Cancer Center

Shizuoka, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia

Hospital Umum Sarawak

Kuching, Malaysia

Beacon Hospital Sdn Bhd

Petaling Jaya, Malaysia

National Cancer Center

Goyang-si, 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

Hosp Univ A Coruna

A Coruña, Spain

General University Hospital of Alicantet

Alicante, Spain

Hosp. Del Mar

Barcelona, Spain

Hosp. de La Santa Creu I Sant Pau

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp Regional Univ de Malaga

Málaga, Spain

Hosp. Virgen Macarena

Seville, Spain

Hosp. Clinico Univ. de Valencia

Valencia, Spain

Hosp. Gral. Univ. Valencia

Valencia, Spain

Cheltenham General Hospital

Cheltenham, United Kingdom

Torbay Hospital-Devon

Devon, United Kingdom

Edinburgh Cancer Centre Western General

Edinburgh, United Kingdom

Leicester Royal Infirmary

Leicester, United Kingdom

University College London Hospitals

London, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Queen Alexandra Hospital

Portsmouth, United Kingdom

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NCT05498428