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

Status: Recruiting
Location: See all (143) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Southern Cancer Center, PC
RECRUITING
Daphne
Clearview Cancer Institute
RECRUITING
Huntsville
Arizona
City of Hope Phoenix
RECRUITING
Goodyear
California
City of Hope Corona
RECRUITING
Corona
City of Hope
RECRUITING
Duarte
Providence Medical Foundation
RECRUITING
Fullerton
Glendale Adventist Medical Center
RECRUITING
Glendale
Los Angeles Cancer Network
RECRUITING
Glendale
Oncology Physicians Network Healthcare
RECRUITING
Glendale
The Oncology Institute of Hope and Innovation
RECRUITING
Glendale
Marin Cancer Center
RECRUITING
Greenbrae
City of Hope Seacliff
RECRUITING
Huntington Beach
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
University of California San Diego Health
RECRUITING
La Jolla
City of Hope Antelope Valley
RECRUITING
Lancaster
City of Hope Long Beach Elm
RECRUITING
Long Beach
Cancer and Blood Specialty Clinic
RECRUITING
Los Alamitos
Cedars Sinai Medical Center
RECRUITING
Los Angeles
USC Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Valkyrie Clinical Trials
RECRUITING
Murrieta
Kaiser Permanente Oakland Medical Center
RECRUITING
Oakland
St. Joseph Hospital Center for Cancer Prevention and Treatment
RECRUITING
Orange
University of California Irvine
RECRUITING
Orange
Sutter Health Palo Alto Medical Foundation
RECRUITING
Palo Alto
Kaiser Permanente Roseville Medical Center
RECRUITING
Roseville
Sutter Institute for Medical Research
RECRUITING
Sacramento
UC Davis Comprehensive Cancer Center
RECRUITING
Sacramento
California Pacific Medical Center
RECRUITING
San Francisco
Kaiser Permanente San Francisco Medical Center
RECRUITING
San Francisco
UCSF Zuckerberg San Francisco General Hospital
RECRUITING
San Francisco
Sansum Clinic
RECRUITING
Santa Barbara
Kaiser Permanente Santa Clara Medical Center
RECRUITING
Santa Clara
Providence Medical Foundation
RECRUITING
Santa Rosa
City of Hope South Pasadena
RECRUITING
South Pasadena
City of Hope Upland
RECRUITING
Upland
Kaiser Permanente Northern California
RECRUITING
Vallejo
John Muir Health Clinical Research Center
RECRUITING
Walnut Creek
Kaiser Permanente Walnut Creek Medical Center
RECRUITING
Walnut Creek
Colorado
National Jewish Health
RECRUITING
Denver
Saint Josephs Hospital Cancer Centers of Colorado
RECRUITING
Denver
Lutheran Hospital Cancer Centers of Colorado
RECRUITING
Golden
Rocky Mountain Cancer Centers
RECRUITING
Lone Tree
Connecticut
Yale New Haven Hospital Yale Cancer Center
RECRUITING
New Haven
Washington, D.c.
MedStar Georgetown University Hospital
RECRUITING
Washington D.c.
Washington DC VA Medical Center
RECRUITING
Washington D.c.
Delaware
ChristianaCare Helen F Graham Cancer Center and Research Institute
RECRUITING
Newark
Florida
Baptist Lynn Cancer Institute
RECRUITING
Boca Raton
The Oncology Institute of Hope and Innovation
RECRUITING
Fort Lauderdale
Florida Cancer Specialists
RECRUITING
Fort Myers
Univ of Florida
RECRUITING
Gainesville
Baptist MD Anderson Cancer Center
RECRUITING
Jacksonville
Mayo Clinic
RECRUITING
Jacksonville
Baptist Health Miami Cancer Institute
RECRUITING
Miami
AdventHealth Orlando
RECRUITING
Orlando
Orlando Health Cancer Institute
RECRUITING
Orlando
Florida Cancer Specialists & Research Institute
RECRUITING
St. Petersburg
Moffitt Cancer Center
RECRUITING
Tampa
Florida Cancer Specialists & Research Institute
RECRUITING
West Palm Beach
Georgia
University Cancer And Blood Center LLC
RECRUITING
Athens
Grady Health System Correll Pavilion
RECRUITING
Atlanta
Piedmont Cancer Institute
RECRUITING
Atlanta
Piedmont Healthcare
RECRUITING
Atlanta
Winship Cancer Institute Emory University
RECRUITING
Atlanta
City of Hope Cancer Center
RECRUITING
Newnan
Iowa
Accellacare of McFarland
RECRUITING
Ames
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Cancer Care Specialists of Central Illinois
RECRUITING
Decatur
Hope and Healing Cancer Services
RECRUITING
Hinsdale
Illinois Cancer Specialists
RECRUITING
Niles
City of Hope Chicago
RECRUITING
Zion
Indiana
Fort Wayne Medical Oncology and Hematology
RECRUITING
Fort Wayne
Investigative Clinical Research of Indiana, LLC
RECRUITING
Noblesville
Kansas
University of Kansas Cancer Center
RECRUITING
Fairway
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Boston University Medical Center
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Maryland
University of Maryland
RECRUITING
Baltimore
Maryland Oncology Hematology P A
RECRUITING
Silver Spring
Michigan
University of Michigan Health System
RECRUITING
Ann Arbor
Trinity Health St Joseph Mercy Ann Arbor
RECRUITING
Ypsilanti
Minnesota
University Of Minnesota
RECRUITING
Minneapolis
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Truman Medical Ctr West
RECRUITING
Kansas City
Oncology Hematology Associates
RECRUITING
Springfield
Washington University School Of Medicine
RECRUITING
St Louis
Mississippi
Jackson Oncology Associates
RECRUITING
Jackson
North Carolina
Atrium Health
RECRUITING
Charlotte
Regional Medical Oncology Center
RECRUITING
Wilson
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New Jersey
Hunterdon Hematology Oncology
RECRUITING
Flemington
Morristown Medical Center
RECRUITING
Morristown
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
Overlook Medical Center
RECRUITING
Summit
Holy Name Medical Center
RECRUITING
Teaneck
New Mexico
University of New Mexico
RECRUITING
Albuquerque
New York
Hematology-Oncology Associates of CNY
RECRUITING
East Syracuse
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
RECRUITING
Mineola
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
RECRUITING
New York
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
RECRUITING
New York
Ellis Hospital
RECRUITING
Schenectady
New York Cancer and Blood Specialists
RECRUITING
Shirley
Montefiore Medical Center
RECRUITING
The Bronx
Clinical Research Alliance Inc
RECRUITING
Westbury
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Oregon
Oncology Associates of Oregon PC Willamette Valley Cancer Institute
RECRUITING
Eugene
Oregon Health And Science University
RECRUITING
Portland
Pennsylvania
Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
RECRUITING
Bryn Mawr
Lankenau Institute for Medical Research Main Line Health Paoli Hospital
RECRUITING
Paoli
Jefferson Health Northeast
RECRUITING
Philadelphia
Philadelphia VA Medical Center
RECRUITING
Philadelphia
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
McGlinn Cancer Institute Reading Hospital
RECRUITING
West Reading
Lankenau Institute for Medical Research
RECRUITING
Wynnewood
South Dakota
Avera Medical Group
RECRUITING
Sioux Falls
Tennessee
Tennessee Oncology
RECRUITING
Chattanooga
Tennessee Cancer Specialists
RECRUITING
Knoxville
University of Tennessee
RECRUITING
Knoxville
Baptist Cancer Center
RECRUITING
Memphis
SCRI Oncology Partners
RECRUITING
Nashville
Tennessee Oncology
RECRUITING
Nashville
Texas
Texas Oncology South
RECRUITING
Austin
Parkland Health and Hospital System
RECRUITING
Dallas
Texas Oncology DFW
RECRUITING
Dallas
UT Southwestern Medical Center
RECRUITING
Dallas
Renovatio Clinical
RECRUITING
El Paso
JPS Health Network
RECRUITING
Fort Worth
MD Anderson Cancer Center
RECRUITING
Houston
Oncology Consultants Texas
RECRUITING
Houston
Community Clinical Trials
RECRUITING
Kingwood
Texas Oncology Odessa-West Texas Cancer Center
RECRUITING
Odessa
Texas Oncology San Antonio Northeast
RECRUITING
San Antonio
Renovatio Clinical
RECRUITING
The Woodlands
Texas Oncology - Northeast
RECRUITING
Tyler
The University of Texas Health Science Center at Tyler
RECRUITING
Tyler
Texas Oncology-Gulf Coast
RECRUITING
Webster
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Vista Oncology
RECRUITING
Olympia
Summit Cancer Centers
RECRUITING
Spokane
Northwest Cancer Specialists - Vancouver
RECRUITING
Vancouver
Other Locations
Israel
Sheba Medical Center
RECRUITING
Ramat Gan
Puerto Rico
Auxilio Mutuo Cancer Center
RECRUITING
San Juan
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2024-12-16
Estimated Completion Date: 2030-12-26
Participants
Target number of participants: 480
Treatments
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.
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

Similar Clinical Trials