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)
NCT ID: NCT06667076
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
480 participants
INTERVENTIONAL
2024-12-16
2030-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Amivantamab
Amivantamab will be administered.
Lazertinib
Lazertinib tablet will be administered.
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.
Amivantamab
Amivantamab will be administered.
Chemotherapy: Pemetrexed
Pemetrexed will be administered.
Chemotherapy: Carboplatin
Carboplatin will be administered.
Interventions
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Amivantamab
Amivantamab will be administered.
Lazertinib
Lazertinib tablet will be administered.
Chemotherapy: Pemetrexed
Pemetrexed will be administered.
Chemotherapy: Carboplatin
Carboplatin will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Southern Cancer Center, PC
Daphne, Alabama, United States
Clearview Cancer Institute
Huntsville, Alabama, United States
City of Hope Phoenix
Goodyear, Arizona, United States
City of Hope Corona
Corona, California, United States
City of Hope
Duarte, California, United States
Providence Medical Foundation
Fullerton, California, United States
The Oncology Institute of Hope and Innovation
Glendale, 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, 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
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
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
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
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
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
Avera Medical Group
Sioux Falls, South Dakota, United States
Tennessee Oncology
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
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
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Auxilio Mutuo Cancer Center
San Juan, , Puerto Rico
Countries
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Central Contacts
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Other Identifiers
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61186372NSC2012
Identifier Type: OTHER
Identifier Source: secondary_id
2025-520730-28-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
61186372NSC2012
Identifier Type: -
Identifier Source: org_study_id