RecruitingPhase 2NCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor

Janssen Research & Development, LLC

Enrollment

480 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Summary

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two treatment combinations — amivantamab plus lazertinib, or amivantamab plus chemotherapy — for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific EGFR gene mutation. The goal is to find the best first-line treatment for this type of lung cancer. **You may be eligible if...** - You have advanced or metastatic NSCLC with an EGFR mutation (exon 19 deletion or L858R) - Your cancer cannot be cured with surgery or radiation - You have at least one measurable tumor on scans - You are in good general health (ECOG 0–1) - Prior treatment side effects have mostly resolved **You may NOT be eligible if...** - You have or had interstitial lung disease (lung scarring) or radiation pneumonitis - You had major surgery within 4 weeks before starting - You have certain heart conditions or active infections - You are pregnant or not using adequate birth control 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.

DRUGLazertinib

Lazertinib tablet will be administered.

DRUGChemotherapy: Pemetrexed

Pemetrexed will be administered.

DRUGChemotherapy: Carboplatin

Carboplatin will be administered.

Locations(196)

Southern Cancer Center, PC

Daphne, Alabama, United States

Clearview Cancer Institute

Huntsville, Alabama, United States

City of Hope Phoenix

Goodyear, Arizona, United States

The Oncology Institute of Hope and Innovation

Cerritos, California, United States

City of Hope Corona

Corona, California, United States

City of Hope

Duarte, California, United States

Providence Medical Foundation

Fullerton, California, United States

Oncology Physicians Network Healthcare

Glendale, California, United States

Los Angeles Cancer Network

Glendale, California, United States

Glendale Adventist Medical Center

Glendale, California, United States

Marin Cancer Center

Greenbrae, California, United States

City of Hope Seacliff

Huntington Beach, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

University of California San Diego Health

La Jolla, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

City of Hope Long Beach Elm

Long Beach, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Valkyrie Clinical Trials Murrieta

Murrieta, California, United States

Kaiser Permanente Oakland Medical Center

Oakland, California, United States

St. Joseph Hospital Center for Cancer Prevention and Treatment

Orange, California, United States

University of California Irvine

Orange, California, United States

Sutter Health Palo Alto Medical Foundation

Palo Alto, California, United States

Kaiser Permanente Roseville Medical Center

Roseville, California, United States

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Sutter Institute for Medical Research

Sacramento, California, United States

California Pacific Medical Center

San Francisco, California, United States

Kaiser Permanente San Francisco Medical Center

San Francisco, California, United States

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Sansum Clinic

Santa Barbara, California, United States

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, United States

Providence Medical Foundation 1

Santa Rosa, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope Upland

Upland, California, United States

Kaiser Permanente Northern California

Vallejo, California, United States

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, United States

John Muir Health Clinical Research Center

Walnut Creek, California, United States

National Jewish Health

Denver, Colorado, United States

Saint Josephs Hospital Cancer Centers of Colorado

Denver, Colorado, United States

Lutheran Hospital Cancer Centers of Colorado

Golden, Colorado, United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado, United States

Yale New Haven Hospital Yale Cancer Center

New Haven, Connecticut, United States

ChristianaCare Helen F Graham Cancer Center and Research Institute

Newark, Delaware, United States

MedStar Georgetown University Hospital

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

Washington DC VA Medical Center

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

Baptist Lynn Cancer Institute

Boca Raton, Florida, United States

The Oncology Institute of Hope and Innovation 1

Fort Lauderdale, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Univ of Florida

Gainesville, Florida, United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Baptist Health Miami Cancer Institute

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Florida Cancer Specialists & Research Institute 1

St. Petersburg, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Florida Cancer Specialists & Research Institute

West Palm Beach, Florida, United States

University Cancer And Blood Center LLC

Athens, Georgia, United States

Grady Health System Correll Pavilion

Atlanta, Georgia, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Piedmont Cancer Institute

Atlanta, Georgia, United States

Winship Cancer Institute Emory University

Atlanta, Georgia, United States

City of Hope Cancer Center

Newnan, Georgia, United States

Rush University Medical Center Rush University Cancer Center Chicago

Chicago, Illinois, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

Illinois Cancer Specialists

Niles, Illinois, United States

Illinois CancerCare

Peoria, Illinois, United States

City of Hope Chicago

Zion, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

Investigative Clinical Research of Indiana, LLC

Noblesville, Indiana, United States

Accellacare of McFarland

Ames, Iowa, United States

University of Kansas Cancer Center

Fairway, Kansas, United States

University of Maryland

Baltimore, Maryland, United States

Maryland Oncology Hematology P A

Silver Spring, Maryland, United States

Boston University Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Trinity Health St Joseph Mercy Ann Arbor

Ypsilanti, Michigan, United States

University Of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Jackson Oncology Associates

Jackson, Mississippi, United States

Truman Medical Ctr West

Kansas City, Missouri, United States

Oncology Hematology Associates

Springfield, Missouri, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hunterdon Hematology Oncology

Flemington, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Overlook Medical Center

Summit, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

Hematology-Oncology Associates of CNY

East Syracuse, New York, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

Mineola, New York, United States

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

New York, New York, United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, United States

Ellis Hospital

Schenectady, New York, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Clinical Research Alliance Inc

Westbury, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Regional Medical Oncology Center

Wilson, North Carolina, United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cincinnati Veterans Affairs Medical Center

Cincinnati, Ohio, United States

Oncology Associates of Oregon PC Willamette Valley Cancer Institute

Eugene, Oregon, United States

Oregon Health And Science University

Portland, Oregon, United States

Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Lankenau Institute for Medical Research Main Line Health Paoli Hospital

Paoli, Pennsylvania, United States

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Jefferson Health Northeast

Philadelphia, Pennsylvania, United States

McGlinn Cancer Institute Reading Hospital

West Reading, Pennsylvania, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Avera Medical Group

Sioux Falls, South Dakota, United States

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, United States

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

University of Tennessee

Knoxville, Tennessee, United States

Baptist Cancer Center

Memphis, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology South

Austin, Texas, United States

Parkland Health and Hospital System

Dallas, Texas, United States

Texas Oncology DFW

Dallas, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Renovatio Clinical

El Paso, Texas, United States

JPS Health Network

Fort Worth, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Oncology Consultants Texas

Houston, Texas, United States

Community Clinical Trials

Kingwood, Texas, United States

Texas Oncology Odessa-West Texas Cancer Center

Odessa, Texas, United States

Texas Oncology San Antonio Northeast

San Antonio, Texas, United States

Renovatio Clinical 1

The Woodlands, Texas, United States

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Texas Oncology - Northeast

Tyler, Texas, United States

Texas Oncology-Gulf Coast

Webster, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Vista Oncology

Olympia, Washington, United States

Summit Cancer Centers

Spokane, Washington, United States

Northwest Cancer Specialists - Vancouver

Vancouver, Washington, United States

Ziekenhuis Oost-Limburg

Genk, Belgium

Ghent University Hospital

Ghent, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

CHU UCL Namur - Site Godinne

Yvoir, Belgium

Helsinki University Hospital

Helsinki, Finland

Oulu University Hospital

Oulu, Finland

Turku University Hospital

Turku, Finland

CHU de Brest - Hopital de la Cavale Blanche

Brest, France

CHU de Grenoble

La Tronche, France

Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital

Marseille, France

I.C.O. Rene Gauducheau

Saint-Herblain, France

St. Elisabeth Hospital Leipzig

Leipzig, Germany

Klinikum der Universitaet Muenchen

München, Germany

Henry Dunant Hospital Center

Athens, Greece

Thoracic General Hospital Of Athens I Sotiria

Athens, Greece

Metaxa Cancer Center Hospital Of Piraeus

Piraeus, Greece

Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, Greece

Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

Soroka Medical Center

Beersheba, Israel

Rambam Medical Center

Haifa, Israel

Meir Medical Center

Kfar Saba, Israel

Sheba Medical Center

Ramat Gan, Israel

Istituto Oncologico Veneto - IRCCS

Padova, Italy

Ospedale S. Maria Delle Croci

Ravenna, Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, Poland

Uls Braga - Hosp. Braga

Braga, Portugal

Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

Guimarães, Portugal

Hosp. Cuf Tejo

Lisbon, Portugal

Uls Loures Odivelas - Hosp. Loures

Loures, Portugal

Ipo Porto

Porto, Portugal

Uls Gaia Espinho

Vila Nova de Gaia, Portugal

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, Spain

Hosp. Univ. I Politecni La Fe

Valencia, Spain

Guy's and St Thomas' NHS Foundation Trust

Greater London, United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

Royal Marsden Hospital 1

London, United Kingdom

The Christie NHS Foundation Trust Christie Hospital

Manchester, United Kingdom

Royal Marsden Hospital

Sutton, United Kingdom

Torbay Hospital-Devon

Torquay, United Kingdom

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NCT06667076