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)

Purpose

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).

Condition

  • Carcinoma, Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 ConformitĂ© EuropĂ©enne (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)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1: Amivantamab and Lazertinib 		Participants will receive Amivantamab in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first.
  • Drug: Amivantamab
    Amivantamab will be administered.
    Other names:
    • JNJ-61186372
  • Drug: Lazertinib
    Lazertinib tablet will be administered.
    Other names:
    • JNJ-73841937
Experimental
Cohort 2: Amivantamab and Chemotherapy 		Participants will receive Amivantamab in combination with chemotherapy (carboplatin and pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first.
  • Drug: Amivantamab
    Amivantamab will be administered.
    Other names:
    • JNJ-61186372
  • Drug: Chemotherapy: Pemetrexed
    Pemetrexed will be administered.
  • Drug: Chemotherapy: Carboplatin
    Carboplatin will be administered.

Recruiting Locations

Southern Cancer Center, PC
Daphne, Alabama 36526

Clearview Cancer Institute
Huntsville, Alabama 35805

City of Hope Phoenix
Goodyear, Arizona 85338

The Oncology Institute of Hope and Innovation
Cerritos, California 90703

City of Hope Corona
Corona, California 92882

City of Hope
Duarte, California 91010

Providence Medical Foundation
Fullerton, California 92835

Los Angeles Cancer Network
Glendale, California 91204

Glendale Adventist Medical Center
Glendale, California 91206

Marin Cancer Center
Greenbrae, California 94904

City of Hope Seacliff
Huntington Beach, California 92648

City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California 92618

University of California San Diego Health
La Jolla, California 92093

City of Hope Antelope Valley
Lancaster, California 93534

City of Hope Long Beach Elm
Long Beach, California 90813

Cancer and Blood Specialty Clinic
Los Alamitos, California 90720

USC Norris Comprehensive Cancer Center
Los Angeles, California 90033

Cedars Sinai Medical Center
Los Angeles, California 90048

Valkyrie Clinical Trials
Los Angeles, California 90067

Valkyrie Clinical Trials Murrieta
Murrieta, California 92562

Kaiser Permanente Oakland Medical Center
Oakland, California 94611

St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California 92868

University of California Irvine
Orange, California 92868

Sutter Health Palo Alto Medical Foundation
Palo Alto, California 94301

Kaiser Permanente Roseville Medical Center
Roseville, California 95661

UC Davis Comprehensive Cancer Center
Sacramento, California 95630

Sutter Institute for Medical Research
Sacramento, California 95816

California Pacific Medical Center
San Francisco, California 94115

Kaiser Permanente San Francisco Medical Center
San Francisco, California 94115

UCSF Zuckerberg San Francisco General Hospital
San Francisco, California 94143

Sansum Clinic
Santa Barbara, California 93105

Kaiser Permanente Santa Clara Medical Center
Santa Clara, California 95051

Providence Medical Foundation 1
Santa Rosa, California 95403

City of Hope South Pasadena
South Pasadena, California 91030

City of Hope Upland
Upland, California 91786

Kaiser Permanente Northern California
Vallejo, California 94589

Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California 94596

John Muir Health Clinical Research Center
Walnut Creek, California 94598

Rocky Mountain Cancer Centers
Lone Tree, Colorado 80124

Yale New Haven Hospital Yale Cancer Center
New Haven, Connecticut 06520

ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware 19713

MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007

Washington DC VA Medical Center
Washington D.C., District of Columbia 20422

Baptist Lynn Cancer Institute
Boca Raton, Florida 33486

The Oncology Institute of Hope and Innovation 1
Fort Lauderdale, Florida 33316

Florida Cancer Specialists
Fort Myers, Florida 33916

Univ of Florida
Gainesville, Florida 32610

Memorial Regional Hospital
Hollywood, Florida 33021 5421

Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207

Mayo Clinic
Jacksonville, Florida 32224

Sylvester Comprehensive Cancer Center
Miami, Florida 33136

Baptist Health Miami Cancer Institute
Miami, Florida 33176

AdventHealth Orlando
Orlando, Florida 32803

Orlando Health Cancer Institute
Orlando, Florida 32806

Memorial Cancer Institute
Pembroke Pines, Florida 33026

Florida Cancer Specialists & Research Institute 1
St. Petersburg, Florida 33701

Moffitt Cancer Center
Tampa, Florida 33612

Florida Cancer Specialists & Research Institute
West Palm Beach, Florida 33401

Grady Health System Correll Pavilion
Atlanta, Georgia 30303

Piedmont Healthcare
Atlanta, Georgia 30309

Piedmont Cancer Institute
Atlanta, Georgia 30318

Winship Cancer Institute Emory University
Atlanta, Georgia 30322

City of Hope Cancer Center
Newnan, Georgia 30265

Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois 60607

University of Illinois at Chicago
Chicago, Illinois 60612

Cancer Care Specialists of Central Illinois
Decatur, Illinois 62526

Illinois Cancer Specialists
Niles, Illinois 60714

Illinois CancerCare
Peoria, Illinois 61615

City of Hope Chicago
Zion, Illinois 60099

Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804

Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana 46062

Accellacare of McFarland
Ames, Iowa 50010

University of Kansas Cancer Center
Fairway, Kansas 66205

University of Maryland
Baltimore, Maryland 21201

Maryland Oncology Hematology P A
Silver Spring, Maryland 20904

Boston University Medical Center
Boston, Massachusetts 02118

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215

Dana Farber Cancer Institute
Boston, Massachusetts 02215

University of Michigan Health System
Ann Arbor, Michigan 48105

Trinity Health St Joseph Mercy Ann Arbor
Ypsilanti, Michigan 48197

University Of Minnesota
Minneapolis, Minnesota 55455

Mayo Clinic Rochester
Rochester, Minnesota 55905

Truman Medical Ctr West
Kansas City, Missouri 64108

Oncology Hematology Associates
Springfield, Missouri 65807

Washington University School Of Medicine
St Louis, Missouri 63110

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756

Morristown Medical Center
Morristown, New Jersey 07960

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901

Overlook Medical Center
Summit, New Jersey 07901

University of New Mexico
Albuquerque, New Mexico 87102

Hematology-Oncology Associates of CNY
East Syracuse, New York 13057

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501

NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York 10016

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York 10032

Ellis Hospital
Schenectady, New York 12308

New York Cancer and Blood Specialists
Shirley, New York 11967

Montefiore Medical Center
The Bronx, New York 10461

Atrium Health
Charlotte, North Carolina 28204

Regional Medical Oncology Center
Wilson, North Carolina 27893

Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157

Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio 45220

Oncology Associates of Oregon PC Willamette Valley Cancer Institute
Eugene, Oregon 97401

Oregon Health And Science University
Portland, Oregon 97239

Philadelphia VA Medical Center
Philadelphia, Pennsylvania 19104

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107

Jefferson Health Northeast
Philadelphia, Pennsylvania 19114

McGlinn Cancer Institute Reading Hospital
West Reading, Pennsylvania 19611

Medical University of South Carolina
Charleston, South Carolina 29425

Tennessee Oncology - Chattanooga
Chattanooga, Tennessee 37404

Tennessee Cancer Specialists
Knoxville, Tennessee 37909

University of Tennessee
Knoxville, Tennessee 37920

SCRI Oncology Partners
Nashville, Tennessee 37203

Tennessee Oncology
Nashville, Tennessee 37203

Texas Oncology South
Austin, Texas 78745

Parkland Health and Hospital System
Dallas, Texas 75235

Texas Oncology DFW
Dallas, Texas 75246

UT Southwestern Medical Center
Dallas, Texas 75390

JPS Health Network
Fort Worth, Texas 76104

MD Anderson Cancer Center
Houston, Texas 77030

Oncology Consultants Texas
Houston, Texas 77030

Community Clinical Trials
Kingwood, Texas 77339

Texas Oncology San Antonio Northeast
San Antonio, Texas 78217

The University of Texas Health Science Center at Tyler
Tyler, Texas 75701

Texas Oncology - Northeast
Tyler, Texas 75702

Texas Oncology-Gulf Coast
Webster, Texas 77598

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Virginia Cancer Specialists
Fairfax, Virginia 22031

Vista Oncology
Olympia, Washington 98506

Summit Cancer Centers
Spokane, Washington 99208

Auxilio Mutuo Cancer Center
San Juan, Puerto Rico 00918

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com