Print Send My Information

Purpose

The primary purpose of the study is to assess how well amivantamab subcutaneous (SC) administration 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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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 in accordance with site standard of care - 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 - 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) or within 12 months 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 subcutaneous (SC) injection in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.
  • Drug: Amivantamab
    Amivantamab will be administered subcutaneously.
    Other names:
    • JNJ-61186372
  • Drug: Lazertinib
    Lazertinib tablet will be administered orally.
    Other names:
    • JNJ-73841937
Experimental
Cohort 2: Amivantamab and Chemotherapy 		Participants will receive Amivantamab SC injection in combination with chemotherapy (carboplatin and pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression, withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first.
  • Drug: Amivantamab
    Amivantamab will be administered subcutaneously.
    Other names:
    • JNJ-61186372
  • Drug: Chemotherapy: Pemetrexed
    Pemetrexed will be administered through IV infusion.
  • Drug: Chemotherapy: Carboplatin
    Carboplatin will be administered through IV infusion.

Recruiting Locations

Clearview Cancer Institute
Huntsville, Alabama 35805

Cancer Treatment Center of America Phoenix
Goodyear, Arizona 85338

City of Hope Corona
Corona, California 92882

City of Hope
Duarte, California 91010

Providence Medical Foundation
Fullerton, California 92835

The Oncology Institute of Hope and Innovation
Glendale, California 90015

Oncology Physicians Network Healthcare
Glendale, California 91203

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

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, 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

Kaiser Permanente Roseville Medical Center
Roseville, California 95661

Kaiser Permanente San Francisco Medical Center
San Francisco, California 94115

UCSF Zuckerberg San Francisco General Hospital
San Francisco, California 94143

Kaiser Permanente Santa Clara Medical Center
Santa Clara, California 95051

Providence Medical Foundation
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

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

MedStar Georgetown University Hospital
Washington, District of Columbia 20007

Washington DC VA Medical Center
Washington, District of Columbia 20422

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

Orlando Health Cancer Institute
Orlando, Florida 32806

Moffitt Cancer Center
Tampa, Florida 33612

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

University of Illinois at Chicago
Chicago, Illinois 60612

Cancer Care Specialists of Central Illinois
Decatur, Illinois 62526

Hope and Healing Cancer Services
Hinsdale, Illinois 60521

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

Maryland Oncology Hematology P A
Silver Spring, Maryland 20904

Boston University Medical Center
Boston, Massachusetts 02118

Trinity Health St Joseph Mercy Ann Arbor
Ypsilanti, Michigan 48197

University Of Minnesota
Minneapolis, Minnesota 55455

Jackson Oncology Associates
Jackson, Mississippi 39202

Washington University School Of Medicine
Saint Louis, Missouri 63110

Oncology Hematology Associates
Springfield, Missouri 65807

Hunterdon Hematology Oncology
Flemington, New Jersey 08822

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

Holy Name Medical Center
Teaneck, New Jersey 07666

University of New Mexico
Albuquerque, New Mexico 87102

Montefiore Medical Center
Bronx, New York 10461

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

Clinical Research Alliance Inc
Westbury, New York 11590

Regional Medical Oncology Center
Wilson, North Carolina 27893

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

Oregon Health And Science University
Portland, Oregon 97239

McGlinn Cancer Institute Reading Hospital
West Reading, Pennsylvania 19611

Avera Medical Group
Sioux Falls, South Dakota 57105

Tennessee Oncology
Chattanooga, Tennessee 37404

University of Tennessee
Knoxville, Tennessee 37920

Baptist Cancer Center
Memphis, Tennessee 38120

SCRI Oncology Partners
Nashville, Tennessee 37203

Tennessee Oncology
Nashville, Tennessee 37203

Texas Oncology P A
Dallas, Texas 75246

UT Southwestern Medical Center
Dallas, Texas 75390

Renovatio Clinical
El Paso, Texas 79915

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

Renovatio Clinical
The Woodlands, Texas 77380

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

Huntsman Cancer Institute
Salt Lake City, Utah 84112

Vista Oncology
Olympia, Washington 98506

Summit Cancer Centers
Spokane, Washington 99208

Northwest Cancer Specialists - Vancouver
Vancouver, Washington 98684

Auxilio Mutuo Cancer Center
San Juan, Puerto Rico 00918

More Details

NCT ID
NCT06667076
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center