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RECRUITING

NCT06667076

PHASE2

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)

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2024-12-16

Completion Date

2030-12-26

Last Updated

2026-11-03

Healthy Volunteers

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Amivantamab

Amivantamab will be administered.

DRUG

Lazertinib

Lazertinib tablet will be administered.

DRUG

Chemotherapy: Pemetrexed

Pemetrexed will be administered.

DRUG

Chemotherapy: Carboplatin

Carboplatin will be administered.

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 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: * 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)

Locations (205)

Southern Cancer Center, PC

Daphne, Alabama, United States

Clearview Cancer Institute

Huntsville, Alabama, United States

City of Hope Phoenix

Goodyear, Arizona, United States

The Oncology Institute of Hope and Innovation

Cerritos, California, United States

City of Hope Corona

Corona, California, United States

City of Hope

Duarte, 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

Providence Medical Foundation

Mission Viejo, California, United States

Valkyrie Clinical Trials Murrieta

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 1

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 1

Fort Lauderdale, Florida, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Univ of Florida

Gainesville, Florida, United States

Memorial Regional Hospital

Hollywood, 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

Memorial Cancer Institute

Pembroke Pines, Florida, United States

Florida Cancer Specialists & Research Institute 1

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

Rush University Medical Center Rush University Cancer Center Chicago

Chicago, Illinois, 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

And 105 more locations on ClinicalTrials.gov

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (205)