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)

Purpose

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).

Condition

  • Carcinoma, Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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 (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

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 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.
  • Drug: Amivantamab
    Amivantamab will be administered.
    Other names:
    • JNJ-61186372
  • Drug: Lazertinib
    Lazertinib tablet will be administered.
    Other names:
    • JNJ-73841937
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.
  • Drug: Amivantamab
    Amivantamab will be administered.
    Other names:
    • JNJ-61186372
  • Drug: Chemotherapy: Pemetrexed
    Pemetrexed will be administered.
  • Drug: Chemotherapy: Carboplatin
    Carboplatin will be administered.

Recruiting Locations

Southern Cancer Center, PC
Daphne 4058219, Alabama 4829764 36526

Clearview Cancer Institute
Huntsville 4068590, Alabama 4829764 35805

City of Hope Phoenix
Goodyear 5296266, Arizona 5551752 85338

The Oncology Institute of Hope and Innovation
Cerritos 5335663, California 5332921 90703

City of Hope Corona
Corona 5339631, California 5332921 92882

City of Hope
Duarte 5344147, California 5332921 91010

Providence Medical Foundation
Fullerton 5351247, California 5332921 92835

Oncology Physicians Network Healthcare
Glendale 5352423, California 5332921 91203

Los Angeles Cancer Network
Glendale 5352423, California 5332921 91204

Glendale Adventist Medical Center
Glendale 5352423, California 5332921 91206

Marin Cancer Center
Greenbrae 5354013, California 5332921 94904

City of Hope Seacliff
Huntington Beach 5358705, California 5332921 92648

City of Hope Orange County Lennar Foundation Cancer Center
Irvine 5359777, California 5332921 92618

University of California San Diego Health
La Jolla 5363943, California 5332921 92093

City of Hope Antelope Valley
Lancaster 5364940, California 5332921 93534

City of Hope Long Beach Elm
Long Beach 5367929, California 5332921 90813

Cancer and Blood Specialty Clinic
Los Alamitos 5368304, California 5332921 90720

USC Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033

Cedars Sinai Medical Center
Los Angeles 5368361, California 5332921 90048

Valkyrie Clinical Trials
Los Angeles 5368361, California 5332921 90067

Valkyrie Clinical Trials
Murrieta 5375911, California 5332921 92562

Kaiser Permanente Oakland Medical Center
Oakland 5378538, California 5332921 94611

St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange 5379513, California 5332921 92868

University of California Irvine
Orange 5379513, California 5332921 92868

Sutter Health Palo Alto Medical Foundation
Palo Alto 5380748, California 5332921 94301

Kaiser Permanente Roseville Medical Center
Roseville 5388881, California 5332921 95661

UC Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95630

Sutter Institute for Medical Research
Sacramento 5389489, California 5332921 95816

California Pacific Medical Center
San Francisco 5391959, California 5332921 94115

Kaiser Permanente San Francisco Medical Center
San Francisco 5391959, California 5332921 94115

UCSF Zuckerberg San Francisco General Hospital
San Francisco 5391959, California 5332921 94143

Sansum Clinic
Santa Barbara 5392952, California 5332921 93105

Kaiser Permanente Santa Clara Medical Center
Santa Clara 5393015, California 5332921 95051

Providence Medical Foundation
Santa Rosa 5393287, California 5332921 95403

City of Hope South Pasadena
South Pasadena 5397717, California 5332921 91030

City of Hope Upland
Upland 5404915, California 5332921 91786

Kaiser Permanente Northern California
Vallejo 5405380, California 5332921 94589

Kaiser Permanente Walnut Creek Medical Center
Walnut Creek 5406990, California 5332921 94596

John Muir Health Clinical Research Center
Walnut Creek 5406990, California 5332921 94598

National Jewish Health
Denver 5419384, Colorado 5417618 80206

Saint Josephs Hospital Cancer Centers of Colorado
Denver 5419384, Colorado 5417618 80218

Lutheran Hospital Cancer Centers of Colorado
Golden 5423294, Colorado 5417618 80401

Rocky Mountain Cancer Centers
Lone Tree 5429208, Colorado 5417618 80124

Yale New Haven Hospital Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06520

ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark 4143861, Delaware 4142224 19713

MedStar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007

Washington DC VA Medical Center
Washington D.C. 4140963, District of Columbia 4138106 20422

Baptist Lynn Cancer Institute
Boca Raton 4148411, Florida 4155751 33486

The Oncology Institute of Hope and Innovation
Fort Lauderdale 4155966, Florida 4155751 33316

Florida Cancer Specialists
Fort Myers 4155995, Florida 4155751 33916

Univ of Florida
Gainesville 4156404, Florida 4155751 32608

Baptist MD Anderson Cancer Center
Jacksonville 4160021, Florida 4155751 32207

Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224

Sylvester Comprehensive Cancer Center
Miami 4164138, Florida 4155751 33136

Baptist Health Miami Cancer Institute
Miami 4164138, Florida 4155751 33176

AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803

Orlando Health Cancer Institute
Orlando 4167147, Florida 4155751 32806

Florida Cancer Specialists & Research Institute
St. Petersburg 4171563, Florida 4155751 33705

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612

Florida Cancer Specialists & Research Institute
West Palm Beach 4177887, Florida 4155751 33401

University Cancer And Blood Center LLC
Athens 4180386, Georgia 4197000 30607

Grady Health System Correll Pavilion
Atlanta 4180439, Georgia 4197000 30303

Piedmont Healthcare
Atlanta 4180439, Georgia 4197000 30309

Piedmont Cancer Institute
Atlanta 4180439, Georgia 4197000 30318

Winship Cancer Institute Emory University
Atlanta 4180439, Georgia 4197000 30322

City of Hope Cancer Center
Newnan 4212684, Georgia 4197000 30265

University of Illinois at Chicago
Chicago 4887398, Illinois 4896861 60612

Cancer Care Specialists of Central Illinois
Decatur 4236895, Illinois 4896861 62526

Hope and Healing Cancer Services
Hinsdale 4896012, Illinois 4896861 60521

Illinois Cancer Specialists
Niles 4903730, Illinois 4896861 60714

Illinois CancerCare
Peoria 4905687, Illinois 4896861 61615

City of Hope Chicago
Zion 4917358, Illinois 4896861 60099

Fort Wayne Medical Oncology and Hematology
Fort Wayne 4920423, Indiana 4921868 46804

Investigative Clinical Research of Indiana, LLC
Noblesville 4924198, Indiana 4921868 46062

Accellacare of McFarland
Ames 4846834, Iowa 4862182 50010

University of Kansas Cancer Center
Fairway 4271358, Kansas 4273857 66205

University of Maryland
Baltimore 4347778, Maryland 4361885 21201

Maryland Oncology Hematology P A
Silver Spring 4369596, Maryland 4361885 20904

Boston University Medical Center
Boston 4930956, Massachusetts 6254926 02118

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

University of Michigan Health System
Ann Arbor 4984247, Michigan 5001836 48105

Trinity Health St Joseph Mercy Ann Arbor
Ypsilanti 5015688, Michigan 5001836 48197

University Of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455

Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905

Jackson Oncology Associates
Jackson 4431410, Mississippi 4436296 39202

Truman Medical Ctr West
Kansas City 4393217, Missouri 4398678 64108

Oncology Hematology Associates
Springfield 4409896, Missouri 4398678 65807

Washington University School Of Medicine
St Louis 4407066, Missouri 4398678 63110

Dartmouth Hitchcock Medical Center
Lebanon 5088597, New Hampshire 5090174 03756

Hunterdon Hematology Oncology
Flemington 5098124, New Jersey 5101760 08822

Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960

Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901

Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901

Holy Name Medical Center
Teaneck 5105262, New Jersey 5101760 07666

University of New Mexico
Albuquerque 5454711, New Mexico 5481136 87102

Hematology-Oncology Associates of CNY
East Syracuse 5116079, New York 5128638 13057

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501

NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York 5128581, New York 5128638 10016

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York 5128581, New York 5128638 10032

Ellis Hospital
Schenectady 5136454, New York 5128638 12308

New York Cancer and Blood Specialists
Shirley 5138022, New York 5128638 11967

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10461

Clinical Research Alliance Inc
Westbury 5144040, New York 5128638 11590

Atrium Health
Charlotte 4460243, North Carolina 4482348 28204

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710

Regional Medical Oncology Center
Wilson 4499389, North Carolina 4482348 27893

University of Cincinnati
Cincinnati 4508722, Ohio 5165418 45219

Cincinnati Veterans Affairs Medical Center
Cincinnati 4508722, Ohio 5165418 45220

Oncology Associates of Oregon PC Willamette Valley Cancer Institute
Eugene 5725846, Oregon 5744337 97401

Oregon Health And Science University
Portland 5746545, Oregon 5744337 97239

Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
Bryn Mawr 5182063, Pennsylvania 6254927 19010

Lankenau Institute for Medical Research Main Line Health Paoli Hospital
Paoli 5205037, Pennsylvania 6254927 19301

Philadelphia VA Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104

Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107

Jefferson Health Northeast
Philadelphia 4560349, Pennsylvania 6254927 19114

McGlinn Cancer Institute Reading Hospital
West Reading 5218867, Pennsylvania 6254927 19611

Lankenau Institute for Medical Research
Wynnewood 5220230, Pennsylvania 6254927 19096

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425

Avera Medical Group
Sioux Falls 5231851, South Dakota 5769223 57105

Tennessee Oncology
Chattanooga 4612862, Tennessee 4662168 37404

Tennessee Cancer Specialists
Knoxville 4634946, Tennessee 4662168 37909

University of Tennessee
Knoxville 4634946, Tennessee 4662168 37920

Baptist Cancer Center
Memphis 4641239, Tennessee 4662168 38120

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203

Texas Oncology South
Austin 4671654, Texas 4736286 78745

Parkland Health and Hospital System
Dallas 4684888, Texas 4736286 75235

Texas Oncology DFW
Dallas 4684888, Texas 4736286 75246

UT Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390

Renovatio Clinical
El Paso 5520993, Texas 4736286 79915

JPS Health Network
Fort Worth 4691930, Texas 4736286 76104

MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

Oncology Consultants Texas
Houston 4699066, Texas 4736286 77030

Community Clinical Trials
Kingwood 7534469, Texas 4736286 77339

Texas Oncology San Antonio Northeast
San Antonio 4726206, Texas 4736286 78217

Renovatio Clinical
The Woodlands 4736476, Texas 4736286 77380

The University of Texas Health Science Center at Tyler
Tyler 4738214, Texas 4736286 75701

Texas Oncology - Northeast
Tyler 4738214, Texas 4736286 75702

Texas Oncology-Gulf Coast
Webster 4740423, Texas 4736286 77598

Huntsman Cancer Institute
Salt Lake City 5780993, Utah 5549030 84112

Virginia Cancer Specialists
Fairfax 4758023, Virginia 6254928 22031

Vista Oncology
Olympia 5805687, Washington 5815135 98506

Summit Cancer Centers
Spokane 5811696, Washington 5815135 99208

Northwest Cancer Specialists - Vancouver
Vancouver 5814616, Washington 5815135 98684

Auxilio Mutuo Cancer Center
San Juan 4568127, Puerto Rico 00918

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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