Recruiting
Phase 2

Amivantamab & Lazertinib, Amivantamab & Platinum-Chemotherapy

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06667076

Conditions

Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amivantamab

Lazertinib

Chemotherapy: Pemetrexed

Chemotherapy: Carboplatin

Study Details

Brief 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).

Conditions

Carcinoma, Non-Small-Cell Lung

Study ID

NCT06667076

Start date

Dec 16, 2024

Status verified date

Aug, 2026

Completion date

Dec 26, 2030

Anticipated

Primary completion date

May 23, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

480 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Amivantamab

Amivantamab will be administered.

Lazertinib

Lazertinib tablet will be administered.

Chemotherapy: Pemetrexed

Pemetrexed will be administered.

Chemotherapy: Carboplatin

Carboplatin will be administered.

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: Up to 4 Years and 6 months ]

Central Contacts and Locations

Central contacts

Study Contact

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

Locations

Southern Cancer Center, PC

Recruiting

Daphne, Alabama, United States, 36526

Clearview Cancer Institute

Recruiting

Huntsville, Alabama, United States, 35805

City of Hope Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

The Oncology Institute of Hope and Innovation

Recruiting

Cerritos, California, United States, 90703

City of Hope Corona

Recruiting

Corona, California, United States, 92882

City of Hope

Recruiting

Duarte, California, United States, 91010

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Los Angeles Cancer Network

Recruiting

Glendale, California, United States, 91204

Glendale Adventist Medical Center

Recruiting

Glendale, California, United States, 91206

Marin Cancer Center

Recruiting

Greenbrae, California, United States, 94904

City of Hope Seacliff

Recruiting

Huntington Beach, California, United States, 92648

City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

University of California San Diego Health

Recruiting

La Jolla, California, United States, 92093

City of Hope Antelope Valley

Recruiting

Lancaster, California, United States, 93534

City of Hope Long Beach Elm

Recruiting

Long Beach, California, United States, 90813

Cancer and Blood Specialty Clinic

Recruiting

Los Alamitos, California, United States, 90720

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Valkyrie Clinical Trials Murrieta

Recruiting

Murrieta, California, United States, 92562

St. Joseph Hospital Center for Cancer Prevention and Treatment

Recruiting

Orange, California, United States, 92868

University of California Irvine

Recruiting

Orange, California, United States, 92868

Sutter Health Palo Alto Medical Foundation

Recruiting

Palo Alto, California, United States, 94301

UC Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95630

Sutter Institute for Medical Research

Recruiting

Sacramento, California, United States, 95816

California Pacific Medical Center

Recruiting

San Francisco, California, United States, 94115

UCSF Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94143

Sansum Clinic

Recruiting

Santa Barbara, California, United States, 93105

Kaiser Permanente Santa Clara Medical Center

Recruiting

Santa Clara, California, United States, 95051

Providence Medical Foundation 1

Recruiting

Santa Rosa, California, United States, 95403

City of Hope South Pasadena

Recruiting

South Pasadena, California, United States, 91030

City of Hope Upland

Recruiting

Upland, California, United States, 91786

Kaiser Permanente Northern California

Recruiting

Vallejo, California, United States, 94589

Kaiser Permanente Walnut Creek Medical Center

Recruiting

Walnut Creek, California, United States, 94596

John Muir Health Clinical Research Center

Recruiting

Walnut Creek, California, United States, 94598

Rocky Mountain Cancer Centers

Recruiting

Lone Tree, Colorado, United States, 80124

Yale New Haven Hospital Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520

ChristianaCare Helen F Graham Cancer Center and Research Institute

Recruiting

Newark, Delaware, United States, 19713

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Washington DC VA Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20422

Baptist Lynn Cancer Institute

Recruiting

Boca Raton, Florida, United States, 33486

The Oncology Institute of Hope and Innovation 1

Recruiting

Fort Lauderdale, Florida, United States, 33316

Florida Cancer Specialists

Recruiting

Fort Myers, Florida, United States, 33916

Univ of Florida

Recruiting

Gainesville, Florida, United States, 32610

Memorial Regional Hospital

Recruiting

Hollywood, Florida, United States, 33021 5421

Baptist MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Baptist Health Miami Cancer Institute

Recruiting

Miami, Florida, United States, 33176

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32806

Memorial Cancer Institute

Recruiting

Pembroke Pines, Florida, United States, 33026

Florida Cancer Specialists & Research Institute 1

Recruiting

St. Petersburg, Florida, United States, 33701

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Florida Cancer Specialists & Research Institute

Recruiting

West Palm Beach, Florida, United States, 33401

Grady Health System Correll Pavilion

Recruiting

Atlanta, Georgia, United States, 30303

Piedmont Healthcare

Recruiting

Atlanta, Georgia, United States, 30309

Piedmont Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30318

Winship Cancer Institute Emory University

Recruiting

Atlanta, Georgia, United States, 30322

City of Hope Cancer Center

Recruiting

Newnan, Georgia, United States, 30265

Rush University Medical Center Rush University Cancer Center Chicago

Recruiting

Chicago, Illinois, United States, 60607

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Cancer Care Specialists of Central Illinois

Recruiting

Decatur, Illinois, United States, 62526

Illinois CancerCare

Recruiting

Peoria, Illinois, United States, 61615

City of Hope Chicago

Recruiting

Zion, Illinois, United States, 60099

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Investigative Clinical Research of Indiana, LLC

Recruiting

Noblesville, Indiana, United States, 46062

Accellacare of McFarland

Recruiting

Ames, Iowa, United States, 50010

University of Kansas Cancer Center

Recruiting

Fairway, Kansas, United States, 66205

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Maryland Oncology Hematology P A

Recruiting

Silver Spring, Maryland, United States, 20904

Boston University Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48105

Trinity Health St Joseph Mercy Ann Arbor

Recruiting

Ypsilanti, Michigan, United States, 48197

University Of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Truman Medical Ctr West

Recruiting

Kansas City, Missouri, United States, 64108

Oncology Hematology Associates

Recruiting

Springfield, Missouri, United States, 65807

Washington University School Of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Overlook Medical Center

Recruiting

Summit, New Jersey, United States, 07901

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87102

Hematology-Oncology Associates of CNY

Recruiting

East Syracuse, New York, United States, 13057

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

Recruiting

Mineola, New York, United States, 11501

NYU Langone Health Laura and Isaac Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Ellis Hospital

Recruiting

Schenectady, New York, United States, 12308

New York Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28204

Regional Medical Oncology Center

Recruiting

Wilson, North Carolina, United States, 27893

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Cincinnati Veterans Affairs Medical Center

Recruiting

Cincinnati, Ohio, United States, 45220

Oncology Associates of Oregon PC Willamette Valley Cancer Institute

Recruiting

Eugene, Oregon, United States, 97401

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

Philadelphia VA Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Jefferson Health Northeast

Recruiting

Philadelphia, Pennsylvania, United States, 19114

McGlinn Cancer Institute Reading Hospital

Recruiting

West Reading, Pennsylvania, United States, 19611

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Tennessee Oncology - Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37404

Tennessee Cancer Specialists

Recruiting

Knoxville, Tennessee, United States, 37909

University of Tennessee

Recruiting

Knoxville, Tennessee, United States, 37920

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology South

Recruiting

Austin, Texas, United States, 78745

Parkland Health and Hospital System

Recruiting

Dallas, Texas, United States, 75235

Texas Oncology DFW

Recruiting

Dallas, Texas, United States, 75246

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

JPS Health Network

Recruiting

Fort Worth, Texas, United States, 76104

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Oncology Consultants Texas

Recruiting

Houston, Texas, United States, 77030

Texas Oncology San Antonio Northeast

Recruiting

San Antonio, Texas, United States, 78217

Community Clinical Trials

Recruiting

Spring, Texas, United States, 77389

The University of Texas Health Science Center at Tyler

Recruiting

Tyler, Texas, United States, 75701

Texas Oncology - Northeast

Recruiting

Tyler, Texas, United States, 75702

Texas Oncology-Gulf Coast

Recruiting

Webster, Texas, United States, 77598

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Vista Oncology

Recruiting

Olympia, Washington, United States, 98506

Summit Cancer Centers

Recruiting

Spokane, Washington, United States, 99208

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.