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NCT06667076PHASE2Recruiting

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)

Janssen Research & Development, LLC

Start Date

12/16/2024

Completion Date

12/26/2030

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy * Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended * Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated * Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement) * Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 Exclusion Criteria: * Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis * Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study * Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing) * Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study * Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

Interventions

DRUG

Amivantamab

DRUG

Lazertinib

DRUG

Chemotherapy: Pemetrexed

DRUG

Chemotherapy: Carboplatin

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Conditions

Carcinoma, Non-Small-Cell Lung

Locations

Southern Cancer Center, PC

Daphne, Alabama 36526

United States

Clearview Cancer Institute

Huntsville, Alabama 35805

United States

City of Hope Phoenix

Goodyear, Arizona 85338

United States

The Oncology Institute of Hope and Innovation

Cerritos, California 90703

United States

City of Hope Corona

Corona, California 92882

United States

City of Hope

Duarte, California 91010

United States

Providence Medical Foundation

Fullerton, California 92835

United States

Oncology Physicians Network Healthcare

Glendale, California 91203

United States

Los Angeles Cancer Network

Glendale, California 91204

United States

Glendale Adventist Medical Center

Glendale, California 91206

United States

Marin Cancer Center

Greenbrae, California 94904

United States

City of Hope Seacliff

Huntington Beach, California 92648

United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California 92618

United States

University of California San Diego Health

La Jolla, California 92093

United States

City of Hope Antelope Valley

Lancaster, California 93534

United States

City of Hope Long Beach Elm

Long Beach, California 90813

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California 90720

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90033

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Valkyrie Clinical Trials

Los Angeles, California 90067

United States

Valkyrie Clinical Trials Murrieta

Murrieta, California 92562

United States

Kaiser Permanente Oakland Medical Center

Oakland, California 94611

United States

St. Joseph Hospital Center for Cancer Prevention and Treatment

Orange, California 92868

United States

University of California Irvine

Orange, California 92868

United States

Sutter Health Palo Alto Medical Foundation

Palo Alto, California 94301

United States

Kaiser Permanente Roseville Medical Center

Roseville, California 95661

United States

UC Davis Comprehensive Cancer Center

Sacramento, California 95630

United States

Sutter Institute for Medical Research

Sacramento, California 95816

United States

California Pacific Medical Center

San Francisco, California 94115

United States

Kaiser Permanente San Francisco Medical Center

San Francisco, California 94115

United States

UCSF Zuckerberg San Francisco General Hospital

San Francisco, California 94143

United States

Sansum Clinic

Santa Barbara, California 93105

United States

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California 95051

United States

Providence Medical Foundation 1

Santa Rosa, California 95403

United States

City of Hope South Pasadena

South Pasadena, California 91030

United States

City of Hope Upland

Upland, California 91786

United States

Kaiser Permanente Northern California

Vallejo, California 94589

United States

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California 94596

United States

John Muir Health Clinical Research Center

Walnut Creek, California 94598

United States

National Jewish Health

Denver, Colorado 80206

United States

Saint Josephs Hospital Cancer Centers of Colorado

Denver, Colorado 80218

United States

Lutheran Hospital Cancer Centers of Colorado

Golden, Colorado 80401

United States

Rocky Mountain Cancer Centers

Lone Tree, Colorado 80124

United States

Yale New Haven Hospital Yale Cancer Center

New Haven, Connecticut 06520

United States

ChristianaCare Helen F Graham Cancer Center and Research Institute

Newark, Delaware 19713

United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia 20007

United States

Washington DC VA Medical Center

Washington D.C., District of Columbia 20422

United States

Baptist Lynn Cancer Institute

Boca Raton, Florida 33486

United States

The Oncology Institute of Hope and Innovation 1

Fort Lauderdale, Florida 33316

United States

Florida Cancer Specialists

Fort Myers, Florida 33916

United States

Univ of Florida

Gainesville, Florida 32610

United States

Memorial Regional Hospital

Hollywood, Florida 33021 5421

United States

Baptist MD Anderson Cancer Center

Jacksonville, Florida 32207

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

Baptist Health Miami Cancer Institute

Miami, Florida 33176

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

Orlando Health Cancer Institute

Orlando, Florida 32806

United States

Memorial Cancer Institute

Pembroke Pines, Florida 33026

United States

Florida Cancer Specialists & Research Institute 1

St. Petersburg, Florida 33701

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Florida Cancer Specialists & Research Institute

West Palm Beach, Florida 33401

United States

University Cancer And Blood Center LLC

Athens, Georgia 30607

United States

Grady Health System Correll Pavilion

Atlanta, Georgia 30303

United States

Piedmont Healthcare

Atlanta, Georgia 30309

United States

Piedmont Cancer Institute

Atlanta, Georgia 30318

United States

Winship Cancer Institute Emory University

Atlanta, Georgia 30322

United States

City of Hope Cancer Center

Newnan, Georgia 30265

United States

Rush University Medical Center Rush University Cancer Center Chicago

Chicago, Illinois 60607

United States

University of Illinois at Chicago

Chicago, Illinois 60612

United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois 62526

United States

Hope and Healing Cancer Services

Hinsdale, Illinois 60521

United States

Illinois Cancer Specialists

Niles, Illinois 60714

United States

Illinois CancerCare

Peoria, Illinois 61615

United States

City of Hope Chicago

Zion, Illinois 60099

United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana 46804

United States

Investigative Clinical Research of Indiana, LLC

Noblesville, Indiana 46062

United States

Accellacare of McFarland

Ames, Iowa 50010

United States

University of Kansas Cancer Center

Fairway, Kansas 66205

United States

University of Maryland

Baltimore, Maryland 21201

United States

Maryland Oncology Hematology P A

Silver Spring, Maryland 20904

United States

Boston University Medical Center

Boston, Massachusetts 02118

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

University of Michigan Health System

Ann Arbor, Michigan 48105

United States

Trinity Health St Joseph Mercy Ann Arbor

Ypsilanti, Michigan 48197

United States

University Of Minnesota

Minneapolis, Minnesota 55455

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Jackson Oncology Associates

Jackson, Mississippi 39202

United States

Truman Medical Ctr West

Kansas City, Missouri 64108

United States

Oncology Hematology Associates

Springfield, Missouri 65807

United States

Washington University School Of Medicine

St Louis, Missouri 63110

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Hunterdon Hematology Oncology

Flemington, New Jersey 08822

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey 08901

United States

Overlook Medical Center

Summit, New Jersey 07901

United States

Holy Name Medical Center

Teaneck, New Jersey 07666

United States

University of New Mexico

Albuquerque, New Mexico 87102

United States

Hematology-Oncology Associates of CNY

East Syracuse, New York 13057

United States

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

Mineola, New York 11501

United States

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

New York, New York 10016

United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York 10032

United States

Ellis Hospital

Schenectady, New York 12308

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Clinical Research Alliance Inc

Westbury, New York 11590

United States

Atrium Health

Charlotte, North Carolina 28204

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Regional Medical Oncology Center

Wilson, North Carolina 27893

United States

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina 27157

United States

University of Cincinnati

Cincinnati, Ohio 45219

United States

Cincinnati Veterans Affairs Medical Center

Cincinnati, Ohio 45220

United States

Oncology Associates of Oregon PC Willamette Valley Cancer Institute

Eugene, Oregon 97401

United States

Oregon Health And Science University

Portland, Oregon 97239

United States

Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital

Bryn Mawr, Pennsylvania 19010

United States

Lankenau Institute for Medical Research Main Line Health Paoli Hospital

Paoli, Pennsylvania 19301

United States

Philadelphia VA Medical Center

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Jefferson Health Northeast

Philadelphia, Pennsylvania 19114

United States

McGlinn Cancer Institute Reading Hospital

West Reading, Pennsylvania 19611

United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania 19096

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Avera Medical Group

Sioux Falls, South Dakota 57105

United States

Tennessee Oncology - Chattanooga

Chattanooga, Tennessee 37404

United States

Tennessee Cancer Specialists

Knoxville, Tennessee 37909

United States

University of Tennessee

Knoxville, Tennessee 37920

United States

Baptist Cancer Center

Memphis, Tennessee 38120

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Texas Oncology South

Austin, Texas 78745

United States

Parkland Health and Hospital System

Dallas, Texas 75235

United States

Texas Oncology DFW

Dallas, Texas 75246

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

Renovatio Clinical

El Paso, Texas 79915

United States

JPS Health Network

Fort Worth, Texas 76104

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Oncology Consultants Texas

Houston, Texas 77030

United States

Texas Oncology Odessa-West Texas Cancer Center

Odessa, Texas 79761

United States

Texas Oncology San Antonio Northeast

San Antonio, Texas 78217

United States

Community Clinical Trials

Spring, Texas 77389

United States

Renovatio Clinical 1

The Woodlands, Texas 77380

United States

The University of Texas Health Science Center at Tyler

Tyler, Texas 75701

United States

Texas Oncology - Northeast

Tyler, Texas 75702

United States

Texas Oncology-Gulf Coast

Webster, Texas 77598

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Vista Oncology

Olympia, Washington 98506

United States

Summit Cancer Centers

Spokane, Washington 99208

United States

Northwest Cancer Specialists - Vancouver

Vancouver, Washington 98684

United States

Ziekenhuis Oost-Limburg

Genk, 3600

Belgium

Ghent University Hospital

Ghent, 9000

Belgium

Universitair Ziekenhuis Leuven

Leuven, 3000

Belgium

CHU UCL Namur - Site Godinne

Yvoir, 5530

Belgium

Helsinki University Hospital

Helsinki, 00290

Finland

Oulu University Hospital

Oulu, 90220

Finland

Turku University Hospital

Turku, 20521

Finland

CHU de Brest - Hopital de la Cavale Blanche

Brest, 29200

France

CHU de Grenoble

La Tronche, 38700

France

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

Marseille, 13005

France

I.C.O. Rene Gauducheau

Saint-Herblain, 44805

France

Universitätsmedizin Greifswald

Greifswald, 17489

Germany

St. Elisabeth Hospital Leipzig

Leipzig, 04277

Germany

Klinikum der Universitaet Muenchen

München, 80336

Germany

Katharinenhospital Innere Medizin

Stuttgart, 70174

Germany

Henry Dunant Hospital Center

Athens, 115 26

Greece

Thoracic General Hospital Of Athens I Sotiria

Athens, 11527

Greece

Metaxa Cancer Center Hospital Of Piraeus

Piraeus, 18537

Greece

Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, 546 39

Greece

Athens Medical Center S A Interbalkan Medical Center of Thessaloniki

Thessaloniki, 54639

Greece

Soroka Medical Center

Beersheba, 8457108

Israel

Rambam Medical Center

Haifa, 3109601

Israel

Meir Medical Center

Kfar Saba, 44281

Israel

Sheba Medical Center

Ramat Gan, 5262000

Israel

Aou San Luigi Gonzaga

Orbassano, 10043

Italy

Istituto Oncologico Veneto - IRCCS

Padova, 35128

Italy

Ospedale S. Maria Delle Croci

Ravenna, 48121

Italy

Fondazione Policlinico Universitario A Gemelli IRCCS

Roma, 00168

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, 85 796

Poland

Centrum Pulmonologii i Torakochirurgii w Bystrej

Bystra, 43 360

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80 952

Poland

Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie

Olsztyn, 10-357

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02-781

Poland

Uls Braga - Hosp. Braga

Braga, 4710 243

Portugal

Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes

Guimarães, 4835 044

Portugal

Hosp. Cuf Tejo

Lisbon, 1350-352

Portugal

Uls Loures Odivelas - Hosp. Loures

Loures, 2674 514

Portugal

Ipo Porto

Porto, 4200 072

Portugal

Uls Gaia Espinho

Vila Nova de Gaia, 4434 502

Portugal

Auxilio Mutuo Cancer Center

San Juan, 00918

Puerto Rico

King Saud University Medical City

Riyadh, 12372

Saudi Arabia

Hosp Univ Vall D Hebron

Barcelona, 08035

Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706

Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026

Spain

Guy's and St Thomas' NHS Foundation Trust

Greater London, SE1 9RT

United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, L78YA

United Kingdom

Royal Marsden Hospital 1

London, SW3 6JJ

United Kingdom

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX

United Kingdom

Royal Marsden Hospital

Sutton, SM2 5PT

United Kingdom

Torbay Hospital-Devon

Torquay, TQ2 7AA

United Kingdom