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)

Last updated: May 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Amivantamab

Chemotherapy: Pemetrexed

Lazertinib

Clinical Study ID

NCT06667076
61186372NSC2012
61186372NSC2012
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have histologically or cytologically confirmed advanced or metastatic non-small celllung cancer (NSCLC) that is not amenable to curative intent therapy

  • Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858Rsubstitution, as detected by food and drug administration (FDA)-approved or othervalidated test in a clinical laboratory improvement amendments (CLIA)-certifiedlaboratory in accordance with site standard of care

  • Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has notbeen previously irradiated

  • Any toxicities from prior systemic anticancer therapy must have resolved to nationalcancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia [any grade], grade <=2 peripheralneuropathy, or grade <=2 hypothyroidism stable on hormone replacement)

  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion

Exclusion Criteria:

  • Medical history of active interstitial lung disease (ILD), including drug-inducedILD or radiation pneumonitis

  • Had major surgery excluding placement of vascular access or tumor biopsy or hadsignificant traumatic injury within 4 weeks before the first dose of anticancertreatments or will not have fully recovered from surgery, or has surgery plannedduring the time the participant is expected to participate in the study

  • Participant has uncontrolled tumor-related pain (symptomatic lesions amenable topalliative radiotherapy should be treated prior to first dosing)

  • Received an investigational treatment that has not been cleared (based on at least 5half lives of any pharmaceutical treatment) or within 12 months before the plannedfirst 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 endpointsof safety or the efficacy of the study treatment(s)

Study Design

Total Participants: 365
Treatment Group(s): 4
Primary Treatment: Amivantamab
Phase: 2
Study Start date:
December 16, 2024
Estimated Completion Date:
June 06, 2029

Connect with a study center

  • Auxilio Mutuo Cancer Center

    San Juan, 00918
    Puerto Rico

    Active - Recruiting

  • Clearview Cancer Institute

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • Cancer Treatment Center of America Phoenix

    Goodyear, Arizona 85338
    United States

    Active - Recruiting

  • City of Hope Corona

    Corona, California 92882
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Glendale Adventist Medical Center

    Glendale, California 91206
    United States

    Active - Recruiting

  • Los Angeles Cancer Network

    Glendale, California 91204
    United States

    Active - Recruiting

  • Oncology Physicians Network Healthcare

    Glendale, California 91203
    United States

    Active - Recruiting

  • The Oncology Institute of Hope and Innovation

    Glendale, California 90015
    United States

    Active - Recruiting

  • Marin Cancer Center

    Greenbrae, California 94904
    United States

    Active - Recruiting

  • City of Hope Seacliff

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California 92618
    United States

    Active - Recruiting

  • City of Hope Antelope Valley

    Lancaster, California 93534
    United States

    Active - Recruiting

  • City of Hope Long Beach Elm

    Long Beach, California 90813
    United States

    Active - Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • Valkyrie Clinical Trials

    Murrieta, California 92562
    United States

    Active - Recruiting

  • Kaiser Permanente Oakland Medical Center

    Oakland, California 94611
    United States

    Active - Recruiting

  • St. Joseph Hospital Center for Cancer Prevention and Treatment

    Orange, California 92868
    United States

    Active - Recruiting

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • Kaiser Permanente Roseville Medical Center

    Roseville, California 95661
    United States

    Active - Recruiting

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California 94115
    United States

    Active - Recruiting

  • UCSF Zuckerberg San Francisco General Hospital

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Kaiser Permanente Santa Clara Medical Center

    Santa Clara, California 95051
    United States

    Active - Recruiting

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • City of Hope South Pasadena

    South Pasadena, California 91030
    United States

    Active - Recruiting

  • City of Hope Upland

    Upland, California 91786
    United States

    Active - Recruiting

  • Kaiser Permanente Northern California

    Vallejo, California 94589
    United States

    Active - Recruiting

  • John Muir Health Clinical Research Center

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Kaiser Permanente Walnut Creek Medical Center

    Walnut Creek, California 94596
    United States

    Active - Recruiting

  • Yale New Haven Hospital Yale Cancer Center

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Washington DC VA Medical Center

    Washington, District of Columbia 20422
    United States

    Active - Recruiting

  • The Oncology Institute of Hope and Innovation

    Fort Lauderdale, Florida 33316
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Grady Health System Correll Pavilion

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Piedmont Cancer Institute

    Atlanta, Georgia 30318
    United States

    Active - Recruiting

  • Piedmont Healthcare

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Winship Cancer Institute Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • City of Hope Cancer Center

    Newnan, Georgia 30265
    United States

    Active - Recruiting

  • University of Illinois at Chicago

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois 62526
    United States

    Active - Recruiting

  • Hope and Healing Cancer Services

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • City of Hope Chicago

    Zion, Illinois 60099
    United States

    Active - Recruiting

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana 46804
    United States

    Active - Recruiting

  • Investigative Clinical Research of Indiana, LLC

    Noblesville, Indiana 46062
    United States

    Active - Recruiting

  • Accellacare of McFarland

    Ames, Iowa 50010
    United States

    Active - Recruiting

  • Maryland Oncology Hematology P A

    Silver Spring, Maryland 20904
    United States

    Active - Recruiting

  • Boston University Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Trinity Health St Joseph Mercy Ann Arbor

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • University Of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Jackson Oncology Associates

    Jackson, Mississippi 39202
    United States

    Active - Recruiting

  • Washington University School Of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Oncology Hematology Associates

    Springfield, Missouri 65807
    United States

    Active - Recruiting

  • Hunterdon Hematology Oncology

    Flemington, New Jersey 08822
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Active - Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

  • University of New Mexico

    Albuquerque, New Mexico 87102
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Hematology-Oncology Associates of CNY

    East Syracuse, New York 13057
    United States

    Active - Recruiting

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

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • NYU Langone Health Laura and Isaac Perlmutter Cancer Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Ellis Hospital

    Schenectady, New York 12308
    United States

    Active - Recruiting

  • New York Cancer and Blood Specialists

    Shirley, New York 11967
    United States

    Active - Recruiting

  • Clinical Research Alliance Inc

    Westbury, New York 11590
    United States

    Active - Recruiting

  • Regional Medical Oncology Center

    Wilson, North Carolina 27893
    United States

    Active - Recruiting

  • Oncology Associates of Oregon PC Willamette Valley Cancer Institute

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Oregon Health And Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • McGlinn Cancer Institute Reading Hospital

    West Reading, Pennsylvania 19611
    United States

    Active - Recruiting

  • Avera Medical Group

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Tennessee Oncology

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • University of Tennessee

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Baptist Cancer Center

    Memphis, Tennessee 38120
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Texas Oncology P A

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Renovatio Clinical

    El Paso, Texas 79915
    United States

    Active - Recruiting

  • JPS Health Network

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Oncology Consultants Texas

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Community Clinical Trials

    Kingwood, Texas 77339
    United States

    Active - Recruiting

  • Renovatio Clinical

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Vista Oncology

    Olympia, Washington 98506
    United States

    Active - Recruiting

  • Summit Cancer Centers

    Spokane, Washington 99208
    United States

    Active - Recruiting

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington 98684
    United States

    Active - Recruiting

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