En undersøgelse af Amivantamab i kombination med Lazertinib eller Amivantamab i kombination med platinbaseret kemoterapi til almindelig epidermal vækstfaktorreceptor (EGFR)-muteret lokalt avanceret eller metastatisk ikke-småcellet lungekræft (NSCLC) (COPERNICUS)
2. november 2026 opdateret af: Janssen Research & Development, LLC
Et fase 2b, åbent, to-kohortestudie af subkutan Amivantamab i kombination med lazertinib som førstelinjebehandling eller subkutan amivantamab i kombination med platinbaseret kemoterapi som andenlinjebehandling til almindelig EGFR-muteret lokalt avanceret eller metastatisk NSCLC
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).
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
480
Fase
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studiesteder
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-
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Genk, Belgien, 3600
- Rekruttering
- Ziekenhuis Oost-Limburg
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Ghent, Belgien, 9000
- Rekruttering
- Ghent University Hospital
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Leuven, Belgien, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Yvoir, Belgien, 5530
- Rekruttering
- CHU UCL Namur - Site Godinne
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-
-
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Greater London, Det Forenede Kongerige, SE1 9RT
- Rekruttering
- Guy's and St Thomas' NHS Foundation Trust
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Liverpool, Det Forenede Kongerige, L78YA
- Rekruttering
- The Clatterbridge Cancer Centre NHS Foundation Trust
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London, Det Forenede Kongerige, SW3 6JJ
- Rekruttering
- Royal Marsden Hospital 1
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Manchester, Det Forenede Kongerige, M20 4BX
- Rekruttering
- The Christie NHS Foundation Trust Christie Hospital
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Sutton, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- Royal Marsden Hospital
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Torquay, Det Forenede Kongerige, TQ2 7AA
- Rekruttering
- Torbay Hospital-Devon
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-
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-
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Helsinki, Finland, 00290
- Rekruttering
- Helsinki University Hospital
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Oulu, Finland, 90220
- Rekruttering
- Oulu University Hospital
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Turku, Finland, 20521
- Rekruttering
- Turku University Hospital
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-
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Alabama
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Daphne, Alabama, Forenede Stater, 36526
- Aktiv, ikke rekrutterende
- Southern Cancer Center, PC
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Huntsville, Alabama, Forenede Stater, 35805
- Afsluttet
- Clearview Cancer Institute
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Arizona
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Goodyear, Arizona, Forenede Stater, 85338
- Aktiv, ikke rekrutterende
- City of Hope Phoenix
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California
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Cerritos, California, Forenede Stater, 90703
- Aktiv, ikke rekrutterende
- The Oncology Institute of Hope and Innovation
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Corona, California, Forenede Stater, 92882
- Aktiv, ikke rekrutterende
- City of Hope Corona
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Duarte, California, Forenede Stater, 91010
- Aktiv, ikke rekrutterende
- City of Hope
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Glendale, California, Forenede Stater, 91206
- Afsluttet
- Glendale Adventist Medical Center
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Glendale, California, Forenede Stater, 91204
- Aktiv, ikke rekrutterende
- Los Angeles Cancer Network
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Glendale, California, Forenede Stater, 91203
- Afsluttet
- Oncology Physicians Network Healthcare
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Greenbrae, California, Forenede Stater, 94904
- Afsluttet
- Marin Cancer Center
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Huntington Beach, California, Forenede Stater, 92648
- Aktiv, ikke rekrutterende
- City of Hope Seacliff
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Irvine, California, Forenede Stater, 92618
- Aktiv, ikke rekrutterende
- City of Hope Orange County Lennar Foundation Cancer Center
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La Jolla, California, Forenede Stater, 92093
- Aktiv, ikke rekrutterende
- University of California San Diego Health
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Lancaster, California, Forenede Stater, 93534
- Rekruttering
- City of Hope Antelope Valley
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Long Beach, California, Forenede Stater, 90813
- Rekruttering
- City of Hope Long Beach Elm
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Los Alamitos, California, Forenede Stater, 90720
- Aktiv, ikke rekrutterende
- Cancer and Blood Specialty Clinic
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Los Angeles, California, Forenede Stater, 90048
- Aktiv, ikke rekrutterende
- Cedars Sinai Medical Center
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Los Angeles, California, Forenede Stater, 90033
- Aktiv, ikke rekrutterende
- USC Norris Comprehensive Cancer Center
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Los Angeles, California, Forenede Stater, 90067
- Aktiv, ikke rekrutterende
- Valkyrie Clinical Trials
-
Mission Viejo, California, Forenede Stater, 92691
- Aktiv, ikke rekrutterende
- Providence Medical Foundation
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Murrieta, California, Forenede Stater, 92562
- Aktiv, ikke rekrutterende
- Valkyrie Clinical Trials Murrieta
-
Oakland, California, Forenede Stater, 94611
- Afsluttet
- Kaiser Permanente Oakland Medical Center
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Orange, California, Forenede Stater, 92868
- Aktiv, ikke rekrutterende
- University of California Irvine
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Orange, California, Forenede Stater, 92868
- Afsluttet
- St. Joseph Hospital Center for Cancer Prevention and Treatment
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Palo Alto, California, Forenede Stater, 94301
- Afsluttet
- Sutter Health Palo Alto Medical Foundation
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Roseville, California, Forenede Stater, 95661
- Afsluttet
- Kaiser Permanente Roseville Medical Center
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Sacramento, California, Forenede Stater, 95816
- Afsluttet
- Sutter Institute for Medical Research
-
Sacramento, California, Forenede Stater, 95630
- Aktiv, ikke rekrutterende
- UC Davis Comprehensive Cancer Center
-
San Francisco, California, Forenede Stater, 94115
- Afsluttet
- Kaiser Permanente San Francisco Medical Center
-
San Francisco, California, Forenede Stater, 94115
- Afsluttet
- California Pacific Medical Center
-
San Francisco, California, Forenede Stater, 94143
- Aktiv, ikke rekrutterende
- UCSF Zuckerberg San Francisco General Hospital
-
Santa Barbara, California, Forenede Stater, 93105
- Aktiv, ikke rekrutterende
- Sansum Clinic
-
Santa Clara, California, Forenede Stater, 95051
- Aktiv, ikke rekrutterende
- Kaiser Permanente Santa Clara Medical Center
-
Santa Rosa, California, Forenede Stater, 95403
- Aktiv, ikke rekrutterende
- Providence Medical Foundation 1
-
South Pasadena, California, Forenede Stater, 91030
- Rekruttering
- City of Hope South Pasadena
-
Upland, California, Forenede Stater, 91786
- Rekruttering
- City of Hope Upland
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Vallejo, California, Forenede Stater, 94589
- Aktiv, ikke rekrutterende
- Kaiser Permanente Northern California
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Walnut Creek, California, Forenede Stater, 94596
- Aktiv, ikke rekrutterende
- Kaiser Permanente Walnut Creek Medical Center
-
Walnut Creek, California, Forenede Stater, 94598
- Aktiv, ikke rekrutterende
- John Muir Health Clinical Research Center
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Colorado
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Denver, Colorado, Forenede Stater, 80206
- Afsluttet
- National Jewish Health
-
Denver, Colorado, Forenede Stater, 80218
- Afsluttet
- Saint Josephs Hospital Cancer Centers of Colorado
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Golden, Colorado, Forenede Stater, 80401
- Afsluttet
- Lutheran Hospital Cancer Centers of Colorado
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Lone Tree, Colorado, Forenede Stater, 80124
- Aktiv, ikke rekrutterende
- Rocky Mountain Cancer Centers
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520
- Aktiv, ikke rekrutterende
- Yale New Haven Hospital Yale Cancer Center
-
-
Delaware
-
Newark, Delaware, Forenede Stater, 19713
- Aktiv, ikke rekrutterende
- ChristianaCare Helen F Graham Cancer Center and Research Institute
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forenede Stater, 20007
- Aktiv, ikke rekrutterende
- MedStar Georgetown University Hospital
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Washington D.C., District of Columbia, Forenede Stater, 20422
- Afsluttet
- Washington DC VA Medical Center
-
-
Florida
-
Boca Raton, Florida, Forenede Stater, 33486
- Aktiv, ikke rekrutterende
- Baptist Lynn Cancer Institute
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Fort Lauderdale, Florida, Forenede Stater, 33316
- Aktiv, ikke rekrutterende
- The Oncology Institute of Hope and Innovation 1
-
Fort Myers, Florida, Forenede Stater, 33916
- Aktiv, ikke rekrutterende
- Florida Cancer Specialists
-
Gainesville, Florida, Forenede Stater, 32610
- Aktiv, ikke rekrutterende
- Univ of Florida
-
Hollywood, Florida, Forenede Stater, 33021 5421
- Rekruttering
- Memorial Regional Hospital
-
Jacksonville, Florida, Forenede Stater, 32207
- Aktiv, ikke rekrutterende
- Baptist MD Anderson Cancer Center
-
Jacksonville, Florida, Forenede Stater, 32224
- Aktiv, ikke rekrutterende
- Mayo Clinic
-
Miami, Florida, Forenede Stater, 33176
- Aktiv, ikke rekrutterende
- Baptist Health Miami Cancer Institute
-
Miami, Florida, Forenede Stater, 33136
- Afsluttet
- Sylvester Comprehensive Cancer Center
-
Orlando, Florida, Forenede Stater, 32803
- Aktiv, ikke rekrutterende
- AdventHealth Orlando
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Orlando, Florida, Forenede Stater, 32806
- Aktiv, ikke rekrutterende
- Orlando Health Cancer Institute
-
Pembroke Pines, Florida, Forenede Stater, 33026
- Rekruttering
- Memorial Cancer Institute
-
St. Petersburg, Florida, Forenede Stater, 33701
- Aktiv, ikke rekrutterende
- Florida Cancer Specialists & Research Institute 1
-
Tampa, Florida, Forenede Stater, 33612
- Aktiv, ikke rekrutterende
- Moffitt Cancer Center
-
West Palm Beach, Florida, Forenede Stater, 33401
- Aktiv, ikke rekrutterende
- Florida Cancer Specialists & Research Institute
-
-
Georgia
-
Athens, Georgia, Forenede Stater, 30607
- Afsluttet
- University Cancer And Blood Center LLC
-
Atlanta, Georgia, Forenede Stater, 30322
- Aktiv, ikke rekrutterende
- Winship Cancer Institute Emory University
-
Atlanta, Georgia, Forenede Stater, 30318
- Aktiv, ikke rekrutterende
- Piedmont Cancer Institute
-
Atlanta, Georgia, Forenede Stater, 30309
- Afsluttet
- Piedmont Healthcare
-
Atlanta, Georgia, Forenede Stater, 30303
- Rekruttering
- Grady Health System Correll Pavilion
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Newnan, Georgia, Forenede Stater, 30265
- Aktiv, ikke rekrutterende
- City of Hope Cancer Center
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-
Illinois
-
Chicago, Illinois, Forenede Stater, 60612
- Aktiv, ikke rekrutterende
- University of Illinois at Chicago
-
Chicago, Illinois, Forenede Stater, 60607
- Aktiv, ikke rekrutterende
- Rush University Medical Center Rush University Cancer Center Chicago
-
Decatur, Illinois, Forenede Stater, 62526
- Afsluttet
- Cancer Care Specialists of Central Illinois
-
Hinsdale, Illinois, Forenede Stater, 60521
- Afsluttet
- Hope and Healing Cancer Services
-
Niles, Illinois, Forenede Stater, 60714
- Afsluttet
- Illinois Cancer Specialists
-
Peoria, Illinois, Forenede Stater, 61615
- Aktiv, ikke rekrutterende
- Illinois CancerCare
-
Zion, Illinois, Forenede Stater, 60099
- Rekruttering
- City of Hope Chicago
-
-
Indiana
-
Fort Wayne, Indiana, Forenede Stater, 46804
- Aktiv, ikke rekrutterende
- Fort Wayne Medical Oncology and Hematology
-
Noblesville, Indiana, Forenede Stater, 46062
- Aktiv, ikke rekrutterende
- Investigative Clinical Research of Indiana, LLC
-
-
Iowa
-
Ames, Iowa, Forenede Stater, 50010
- Aktiv, ikke rekrutterende
- Accellacare of McFarland
-
-
Kansas
-
Fairway, Kansas, Forenede Stater, 66205
- Aktiv, ikke rekrutterende
- University of Kansas Cancer Center
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- Rekruttering
- University of Maryland
-
Silver Spring, Maryland, Forenede Stater, 20904
- Aktiv, ikke rekrutterende
- Maryland Oncology Hematology P A
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Aktiv, ikke rekrutterende
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Forenede Stater, 02215
- Aktiv, ikke rekrutterende
- Dana Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02118
- Aktiv, ikke rekrutterende
- Boston University Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48105
- Afsluttet
- University of Michigan Health System
-
Ypsilanti, Michigan, Forenede Stater, 48197
- Aktiv, ikke rekrutterende
- Trinity Health St Joseph Mercy Ann Arbor
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- Afsluttet
- University Of Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Aktiv, ikke rekrutterende
- Mayo Clinic Rochester
-
-
Mississippi
-
Jackson, Mississippi, Forenede Stater, 39202
- Afsluttet
- Jackson Oncology Associates
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64108
- Rekruttering
- Truman Medical Ctr West
-
Springfield, Missouri, Forenede Stater, 65807
- Afsluttet
- Oncology Hematology Associates
-
St Louis, Missouri, Forenede Stater, 63110
- Aktiv, ikke rekrutterende
- Washington University School Of Medicine
-
-
New Hampshire
-
Lebanon, New Hampshire, Forenede Stater, 03756
- Aktiv, ikke rekrutterende
- Dartmouth Hitchcock Medical Center
-
-
New Jersey
-
Flemington, New Jersey, Forenede Stater, 08822
- Afsluttet
- Hunterdon Hematology Oncology
-
Morristown, New Jersey, Forenede Stater, 07960
- Aktiv, ikke rekrutterende
- Morristown Medical Center
-
New Brunswick, New Jersey, Forenede Stater, 08901
- Aktiv, ikke rekrutterende
- Rutgers Cancer Institute of New Jersey
-
Summit, New Jersey, Forenede Stater, 07901
- Rekruttering
- Overlook Medical Center
-
Teaneck, New Jersey, Forenede Stater, 07666
- Afsluttet
- Holy Name Medical Center
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87102
- Afsluttet
- University of New Mexico
-
-
New York
-
East Syracuse, New York, Forenede Stater, 13057
- Aktiv, ikke rekrutterende
- Hematology-Oncology Associates of CNY
-
Mineola, New York, Forenede Stater, 11501
- Aktiv, ikke rekrutterende
- Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
-
New York, New York, Forenede Stater, 10032
- Afsluttet
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
-
New York, New York, Forenede Stater, 10016
- Aktiv, ikke rekrutterende
- NYU Langone Health Laura and Isaac Perlmutter Cancer Center
-
Schenectady, New York, Forenede Stater, 12308
- Aktiv, ikke rekrutterende
- Ellis Hospital
-
Shirley, New York, Forenede Stater, 11967
- Aktiv, ikke rekrutterende
- New York Cancer and Blood Specialists
-
The Bronx, New York, Forenede Stater, 10461
- Aktiv, ikke rekrutterende
- Montefiore Medical Center
-
Westbury, New York, Forenede Stater, 11590
- Afsluttet
- Clinical Research Alliance Inc
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28204
- Aktiv, ikke rekrutterende
- Atrium Health
-
Durham, North Carolina, Forenede Stater, 27710
- Afsluttet
- Duke University Medical Center
-
Wilson, North Carolina, Forenede Stater, 27893
- Aktiv, ikke rekrutterende
- Regional Medical Oncology Center
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Afsluttet
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45219
- Afsluttet
- University of Cincinnati
-
Cincinnati, Ohio, Forenede Stater, 45220
- Afsluttet
- Cincinnati Veterans Affairs Medical Center
-
-
Oregon
-
Eugene, Oregon, Forenede Stater, 97401
- Aktiv, ikke rekrutterende
- Oncology Associates of Oregon PC Willamette Valley Cancer Institute
-
Portland, Oregon, Forenede Stater, 97239
- Aktiv, ikke rekrutterende
- Oregon Health And Science University
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, Forenede Stater, 19010
- Afsluttet
- Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
-
Paoli, Pennsylvania, Forenede Stater, 19301
- Afsluttet
- Lankenau Institute for Medical Research Main Line Health Paoli Hospital
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Aktiv, ikke rekrutterende
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Afsluttet
- Philadelphia VA Medical Center
-
Philadelphia, Pennsylvania, Forenede Stater, 19114
- Afsluttet
- Jefferson Health Northeast
-
West Reading, Pennsylvania, Forenede Stater, 19611
- Aktiv, ikke rekrutterende
- McGlinn Cancer Institute Reading Hospital
-
Wynnewood, Pennsylvania, Forenede Stater, 19096
- Afsluttet
- Lankenau Institute for Medical Research
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Aktiv, ikke rekrutterende
- Medical University of South Carolina
-
-
South Dakota
-
Sioux Falls, South Dakota, Forenede Stater, 57105
- Afsluttet
- Avera Medical Group
-
-
Tennessee
-
Chattanooga, Tennessee, Forenede Stater, 37404
- Aktiv, ikke rekrutterende
- Tennessee Oncology - Chattanooga
-
Knoxville, Tennessee, Forenede Stater, 37920
- Aktiv, ikke rekrutterende
- University of Tennessee
-
Knoxville, Tennessee, Forenede Stater, 37909
- Aktiv, ikke rekrutterende
- Tennessee Cancer Specialists
-
Memphis, Tennessee, Forenede Stater, 38120
- Afsluttet
- Baptist Cancer Center
-
Nashville, Tennessee, Forenede Stater, 37203
- Aktiv, ikke rekrutterende
- Tennessee Oncology
-
Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- SCRI Oncology Partners
-
-
Texas
-
Austin, Texas, Forenede Stater, 78745
- Aktiv, ikke rekrutterende
- Texas Oncology South
-
Dallas, Texas, Forenede Stater, 75235
- Rekruttering
- Parkland Health and Hospital System
-
Dallas, Texas, Forenede Stater, 75390
- Aktiv, ikke rekrutterende
- UT Southwestern Medical Center
-
Dallas, Texas, Forenede Stater, 75246
- Aktiv, ikke rekrutterende
- Texas Oncology DFW
-
El Paso, Texas, Forenede Stater, 79915
- Afsluttet
- Renovatio Clinical
-
Fort Worth, Texas, Forenede Stater, 76104
- Afsluttet
- JPS Health Network
-
Houston, Texas, Forenede Stater, 77030
- Aktiv, ikke rekrutterende
- MD Anderson Cancer Center
-
Houston, Texas, Forenede Stater, 77030
- Aktiv, ikke rekrutterende
- Oncology Consultants Texas
-
Odessa, Texas, Forenede Stater, 79761
- Afsluttet
- Texas Oncology Odessa-West Texas Cancer Center
-
San Antonio, Texas, Forenede Stater, 78217
- Aktiv, ikke rekrutterende
- Texas Oncology San Antonio Northeast
-
Spring, Texas, Forenede Stater, 77389
- Afsluttet
- Community Clinical Trials
-
The Woodlands, Texas, Forenede Stater, 77380
- Afsluttet
- Renovatio Clinical 1
-
Tyler, Texas, Forenede Stater, 75702
- Aktiv, ikke rekrutterende
- Texas Oncology - Northeast
-
Tyler, Texas, Forenede Stater, 75701
- Aktiv, ikke rekrutterende
- The University of Texas Health Science Center at Tyler
-
Webster, Texas, Forenede Stater, 77598
- Afsluttet
- Texas Oncology-Gulf Coast
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84112
- Aktiv, ikke rekrutterende
- Huntsman Cancer Institute
-
-
Virginia
-
Fairfax, Virginia, Forenede Stater, 22031
- Aktiv, ikke rekrutterende
- Virginia Cancer Specialists
-
-
Washington
-
Olympia, Washington, Forenede Stater, 98506
- Aktiv, ikke rekrutterende
- Vista Oncology
-
Spokane, Washington, Forenede Stater, 99208
- Aktiv, ikke rekrutterende
- Summit Cancer Centers
-
Vancouver, Washington, Forenede Stater, 98684
- Afsluttet
- Northwest Cancer Specialists - Vancouver
-
-
-
-
-
Brest, Frankrig, 29200
- Rekruttering
- CHU de Brest - Hopital de la Cavale Blanche
-
La Tronche, Frankrig, 38700
- Rekruttering
- CHU de Grenoble
-
Marseille, Frankrig, 13005
- Rekruttering
- Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital
-
Saint-Herblain, Frankrig, 44805
- Rekruttering
- I.C.O. Rene Gauducheau
-
-
-
-
-
Athens, Grækenland, 115 26
- Rekruttering
- Henry Dunant Hospital Center
-
Athens, Grækenland, 11527
- Rekruttering
- Thoracic General Hospital Of Athens I Sotiria
-
Piraeus, Grækenland, 18537
- Rekruttering
- Metaxa Cancer Center Hospital Of Piraeus
-
Thessaloniki, Grækenland, 546 39
- Rekruttering
- Anticancer Hospital of Thessaloniki Theageneio
-
Thessaloniki, Grækenland, 54639
- Rekruttering
- Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
-
-
-
-
-
Beersheba, Israel, 8457108
- Rekruttering
- Soroka Medical Center
-
Haifa, Israel, 3109601
- Rekruttering
- Rambam Medical Center
-
Kfar Saba, Israel, 44281
- Rekruttering
- Meir Medical Center
-
Ramat Gan, Israel, 5262000
- Rekruttering
- Sheba Medical Center
-
-
-
-
-
Orbassano, Italien, 10043
- Rekruttering
- Aou San Luigi Gonzaga
-
Padova, Italien, 35128
- Rekruttering
- Istituto Oncologico Veneto - IRCCS
-
Ravenna, Italien, 48121
- Rekruttering
- Ospedale S. Maria Delle Croci
-
Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario A Gemelli IRCCS
-
Rozzano, Italien, 20089
- Rekruttering
- Istituto Clinico Humanitas
-
-
-
-
-
Bydgoszcz, Polen, 85 796
- Rekruttering
- Centrum Onkologii im Prof F Lukaszczyka
-
Bystra, Polen, 43 360
- Rekruttering
- Centrum Pulmonologii i Torakochirurgii w Bystrej
-
Gdansk, Polen, 80 952
- Rekruttering
- Uniwersyteckie Centrum Kliniczne
-
Olsztyn, Polen, 10-357
- Rekruttering
- Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
-
Warsaw, Polen, 02-781
- Rekruttering
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
-
-
-
-
-
Braga, Portugal, 4710 243
- Rekruttering
- Uls Braga - Hosp. Braga
-
Guimarães, Portugal, 4835 044
- Rekruttering
- Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
-
Lisbon, Portugal, 1350-352
- Rekruttering
- Hosp. Cuf Tejo
-
Loures, Portugal, 2674 514
- Rekruttering
- Uls Loures Odivelas - Hosp. Loures
-
Porto, Portugal, 4200 072
- Rekruttering
- Ipo Porto
-
Vila Nova de Gaia, Portugal, 4434 502
- Rekruttering
- Uls Gaia Espinho
-
-
-
-
-
San Juan, Puerto Rico, 00918
- Rekruttering
- Auxilio Mutuo Cancer Center
-
-
-
-
-
Riyadh, Saudi Arabien, 12713
- Rekruttering
- King Faisal Specialist Hospital & Research Center
-
Riyadh, Saudi Arabien, 14611
- Rekruttering
- King Abdulaziz Medical City
-
Riyadh, Saudi Arabien, 12372
- Rekruttering
- King Saud University Medical City
-
-
-
-
-
Barcelona, Spanien, 08035
- Rekruttering
- Hosp Univ Vall D Hebron
-
Jerez de la Frontera, Spanien, 11407
- Rekruttering
- Hosp. de Jerez de La Frontera
-
Madrid, Spanien, 28041
- Rekruttering
- Hosp. Univ. 12 de Octubre
-
Santiago de Compostela, Spanien, 15706
- Rekruttering
- Hosp. Clinico Univ. de Santiago
-
Valencia, Spanien, 46026
- Rekruttering
- Hosp. Univ. I Politecni La Fe
-
-
-
-
-
Greifswald, Tyskland, 17489
- Rekruttering
- Universitätsmedizin Greifswald
-
Leipzig, Tyskland, 04277
- Rekruttering
- St. Elisabeth Hospital Leipzig
-
München, Tyskland, 80336
- Rekruttering
- Klinikum der Universitaet Muenchen
-
Stuttgart, Tyskland, 70174
- Rekruttering
- Katharinenhospital Innere Medizin
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: 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 will be administered.
Andre navne:
Lazertinib tablet will be administered.
Andre navne:
|
|
Eksperimentel: 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 will be administered.
Andre navne:
Pemetrexed will be administered. Carboplatin will be administered. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS)
Tidsramme: Up to 4 Years and 6 months
|
PFS is defined as the time from the date of first dose of any study treatment until the date of objective disease progression or death, whichever occurs first according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the investigator. |
Up to 4 Years and 6 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations
Tidsramme: Up to 4 Years and 6 months
|
Participants with dose reductions, interruptions, and discontinuations will be reported. |
Up to 4 Years and 6 months
|
|
Number of Participants With Venous Thromboembolic Events (VTEs)
Tidsramme: Up to 4 Years and 6 months
|
Participants with signs and symptoms (dyspnea, tachypnea, upper- or lower-extremity swelling and discoloration) of VTE events, specifically pulmonary embolism, and deep vein thrombosis will be reported as monitored by the investigators. |
Up to 4 Years and 6 months
|
|
Number of Participants With Dermatologic Adverse Events (AEs)
Tidsramme: Up to 4 Years and 6 months
|
Participants with dermatologic AEs will be reported. |
Up to 4 Years and 6 months
|
|
Number of Participants with AEs by Severity
Tidsramme: Up to 4 Years and 6 months
|
Severity of AEs will be graded according to the national cancer institute common terminology criteria for adverse event (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening and Grade 5: death related to adverse event. |
Up to 4 Years and 6 months
|
|
Overall Survival (OS)
Tidsramme: Up to 4 Years and 6 months
|
OS is defined as the time from the date of first dose of any study treatment until the date of death due to any cause. |
Up to 4 Years and 6 months
|
|
Overall Response Rate (ORR)
Tidsramme: Up to 4 Years and 6 months
|
ORR is defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR) as their best response both confirmed and unconfirmed, as defined using RECIST v1.1. |
Up to 4 Years and 6 months
|
|
Clinical Benefit Rate (CBR)
Tidsramme: Up to 4 Years and 6 months
|
CBR is defined as the percentage of participants achieving CR or PR, both confirmed and unconfirmed, or durable stable disease (SD) of a duration of at least 11 weeks as defined using RECIST v1.1. |
Up to 4 Years and 6 months
|
|
Duration of Response (DOR)
Tidsramme: Up to 4 Years and 6 months
|
DOR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever occurs first, for participants who have PR or CR. |
Up to 4 Years and 6 months
|
|
Time to Treatment Discontinuation (TTTD)
Tidsramme: Up to 4 Years and 6 months
|
TTTD is defined as the date from the date of first dose of any study treatment until discontinuation of study treatment for any reason, including disease progression, treatment toxicity or death, based on RECIST v 1.1. |
Up to 4 Years and 6 months
|
|
Time to Subsequent Therapy (TTST)
Tidsramme: Up to 4 Years and 6 months
|
TTST is defined as the time from the date of first dose of any study treatment until the start date of the subsequent anticancer therapy following study treatment discontinuation or death, whichever occurs first. |
Up to 4 Years and 6 months
|
|
Time to Symptomatic Progression (TTSP)
Tidsramme: Up to 4 Years and 6 months
|
TTSP is defined as the time from date of first dose of any study treatment to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in systemic anticancer treatment and/or clinical intervention to manage symptoms or death. |
Up to 4 Years and 6 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
16. december 2024
Primær færdiggørelse (Anslået)
Primær færdiggørelse
23. maj 2029
Studieafslutning (Anslået)
Studieafslutning
26. december 2030
Datoer for studieregistrering
Først indsendt
Først indsendt
30. oktober 2024
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
30. oktober 2024
Først opslået (Faktiske)
Først opslået
31. oktober 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
3. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2026
Sidst verificeret
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 61186372NSC2012
- 61186372NSC2012 (Anden identifikator: Janssen Research & Development, LLC)
- 2025-520730-28-00 (Registry Identifier: EUCT number)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .