Klinisk undersøgelse af Ivonescimab til førstelinjebehandling af metastatisk NSCLC-patienter med høj PD-L1 (HARMONi-7)
17. september 2026 opdateret af: Summit Therapeutics
Et randomiseret, dobbeltblindet, multiregionalt fase 3-studie af Ivonescimab versus Pembrolizumab til førstelinjebehandling af metastatisk ikke-småcellet lungekræft hos patienter, hvis tumorer viser høj PD-L1-ekspression (TPS ≥ 50 %)
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
780
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Summit Clinical Trial Information
- Telefonnummer: 1-833-256-0522
- E-mail: medicalinformation@smmttx.com
Studiesteder
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Charleroi, Belgien, 09600
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Ghent, Belgien, 09000
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Hainaut
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Mons, Hainaut, Belgien, 07000
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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Ontario
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Etobicoke, Ontario, Canada, M9V 1R8
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London, Ontario, Canada, N6A 5W9
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
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Phoenix, Arizona, Forenede Stater, 85006
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Arkansas
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Hot Springs, Arkansas, Forenede Stater, 71913
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Jonesboro, Arkansas, Forenede Stater, 72401
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- Clinical Study Sites
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California
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Alameda, California, Forenede Stater, 90720
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Anaheim, California, Forenede Stater, 92805
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- Clinical Study Site
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Beverly Hills, California, Forenede Stater, 90211
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- Clinical Study Site
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Cerritos, California, Forenede Stater, 90703
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- Clinical Study Site
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Los Angeles, California, Forenede Stater, 90067
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- Clinical Study Site
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Los Angeles, California, Forenede Stater, 90034
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- Clinical Study Site
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Orange, California, Forenede Stater, 92868
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Oxnard, California, Forenede Stater, 93030
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- Clinical Study Site
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San Diego, California, Forenede Stater, 92123
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Sunnyvale, California, Forenede Stater, 94086
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- Clinical Study Site
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Torrance, California, Forenede Stater, 90505
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- Clinical Study Site
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
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Denver, Colorado, Forenede Stater, 80210
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Grand Junction, Colorado, Forenede Stater, 81505
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Lone Tree, Colorado, Forenede Stater, 80124
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Loveland, Colorado, Forenede Stater, 80538
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Florida
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Fort Lauderdale, Florida, Forenede Stater, 33317
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Fort Lauderdale, Florida, Forenede Stater, 33308
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- Clinical Study Sites
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Jacksonville, Florida, Forenede Stater, 32207
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Jacksonville Beach, Florida, Forenede Stater, 32256
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North Venice, Florida, Forenede Stater, 34275
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Ocala, Florida, Forenede Stater, 34474
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Orlando, Florida, Forenede Stater, 32822
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Pensacola, Florida, Forenede Stater, 32504
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Plantation, Florida, Forenede Stater, 33323
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- Clinical Study Site
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St. Petersburg, Florida, Forenede Stater, 33709
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- Clinical Study Site
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Tallahassee, Florida, Forenede Stater, 32308
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- Clinical Study Site
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Tamarac, Florida, Forenede Stater, 33321
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- Clinical Study Site
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West Palm Beach, Florida, Forenede Stater, 33401
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Georgia
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Atlanta, Georgia, Forenede Stater, 30318
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Warner Robins, Georgia, Forenede Stater, 31088
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- Clinical Study Site
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Illinois
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Carterville, Illinois, Forenede Stater, 62918
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- Clinical Study Site
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Chicago, Illinois, Forenede Stater, 60611
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- Clinical Study Site
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Chicago, Illinois, Forenede Stater, 60612
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- Clinical Study Site
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Evanston, Illinois, Forenede Stater, 60201
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- Clinical Study Site
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46237
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- Clinical Study Site
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Iowa
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Waukee, Iowa, Forenede Stater, 50263
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- Clinical Study Site
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
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- Clinical Study Site
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Louisiana
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Covington, Louisiana, Forenede Stater, 70433
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Maryland
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Baltimore, Maryland, Forenede Stater, 21229
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
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Brighton, Massachusetts, Forenede Stater, 21350
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Foxborough, Massachusetts, Forenede Stater, 02035
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- Clinical Study Site
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Methuen, Massachusetts, Forenede Stater, 01844
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- Clinical Study Site
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Milford, Massachusetts, Forenede Stater, 01757
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- Clinical Study Site
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Weymouth, Massachusetts, Forenede Stater, 02190
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- Clinical Study Site
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Worcester, Massachusetts, Forenede Stater, 01655
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- Clinical Study Site
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
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- Clinical Study Site
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Detroit, Michigan, Forenede Stater, 48202
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- Clinical Study Sites
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Detroit, Michigan, Forenede Stater, 48201
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- Clinical Study Site
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
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- Clinical Study Sites
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Minneapolis, Minnesota, Forenede Stater, 55455
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- Clinical Study Site
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Saint Paul, Minnesota, Forenede Stater, 55101
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- Clinical Study Site
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
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- Clinical Study Site
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Missouri
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Kansas City, Missouri, Forenede Stater, 64132
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- Clinical Study Site
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St Louis, Missouri, Forenede Stater, 63128
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- Clinical Study Site
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St Louis, Missouri, Forenede Stater, 63141
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- Clinical Study Site
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
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- Clinical Study Site
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New Jersey
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Mullica Hill, New Jersey, Forenede Stater, 08062
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- Clinical Study Site
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New Brunswick, New Jersey, Forenede Stater, 08901
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- Clinical Study Site
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New York
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New York, New York, Forenede Stater, 10065
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- Clinical Study Site
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Syracuse, New York, Forenede Stater, 13210
- Rekruttering
- Clinical Study Site
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The Bronx, New York, Forenede Stater, 10461
- Rekruttering
- Clinical Site
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
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- Clinical Study Site
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Durham, North Carolina, Forenede Stater, 27708
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- Clinical Study Site
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Pinehurst, North Carolina, Forenede Stater, 28374
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- Clinical Study Site
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220
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- Clinical Study Sites
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Cleveland, Ohio, Forenede Stater, 44195
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- Clinical Study Site
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Columbus, Ohio, Forenede Stater, 43219
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- Clinical Study Site
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Columbus, Ohio, Forenede Stater, 43210
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- Clinical Study Sites
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73102
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- Clinical Study Site
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
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- Clinical Study Site
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Portland, Oregon, Forenede Stater, 97239
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- Clinical Study Site
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19111
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- Clinical Study Site
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Pittsburgh, Pennsylvania, Forenede Stater, 15232
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- Clinical Study Site
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
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- Clinical Study Site
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37235
- Rekruttering
- Clinical Study Site
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Nashville, Tennessee, Forenede Stater, 37203
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- Clinical Study Sites
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Texas
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Abilene, Texas, Forenede Stater, 79601
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- Clinical Study Site
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Austin, Texas, Forenede Stater, 78745
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- Clinical Study Site
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Dallas, Texas, Forenede Stater, 75246
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- Clinical Study Site
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Fort Worth, Texas, Forenede Stater, 76104
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Houston, Texas, Forenede Stater, 77030
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- Clinical Study Site
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Tyler, Texas, Forenede Stater, 75708
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- Clinical Study Site
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Webster, Texas, Forenede Stater, 77598
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- Clinical Study Site
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Utah
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Salt Lake City, Utah, Forenede Stater, 84106
- Rekruttering
- Clinical Study Site
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Virginia
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Blacksburg, Virginia, Forenede Stater, 24061
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- Clinical Study Site
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Charlottesville, Virginia, Forenede Stater, 22908
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- Clinical Study Site
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Fairfax, Virginia, Forenede Stater, 22031
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- Clinical Study Site
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Richmond, Virginia, Forenede Stater, 23229
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- Clinical Study Site
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Richmond, Virginia, Forenede Stater, 23298
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- Clinical Study Site
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Washington
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Seattle, Washington, Forenede Stater, 98109
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- Clinical Study Site
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Vancouver, Washington, Forenede Stater, 98684
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Avignon, Frankrig
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- Clinical Study Site
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Brest, Frankrig, 29200
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- Clinical Study Site
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Créteil, Frankrig, 94010
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- Clinical Study Site
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Lille, Frankrig, 59000
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- Clinical Study Site
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Lyon, Frankrig, 69008
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- Clinical Study Site
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Marseille, Frankrig, 13000
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- Clinical Study Site
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Paris, Frankrig, 75020
- Rekruttering
- Clinical Study Site
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Paris, Frankrig, 75248
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- Clinical Study Site
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Rennes, Frankrig, 35033
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- Clinical Study Site
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Strasbourg, Frankrig
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- Clinical Study Site
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Toulon, Frankrig
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- Clinical Study Site
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Toulouse, Frankrig
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- Clinical Study Site
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Villejuif, Frankrig, 94800
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- Clinical Study Site
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Pays de Loire
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Nantes, Pays de Loire, Frankrig, 44277
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Athens, Grækenland, 15562
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- Clinical Study Site
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Athens, Grækenland, 10431
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- Clinical Study Site
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Athens, Grækenland, 12462
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- Clinical Study Sites
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Athens, Grækenland, 18547
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- Clinical Study Sites
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Rio, Grækenland, 26504
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- Clinical Study Site
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Thessaloniki, Grækenland, 54622
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Bari, Italien, 70124
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- Clinical Study Site
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Bergamo, Italien, 24125
- Rekruttering
- Clinical Study Site
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Milan, Italien, 20037
- Rekruttering
- Clinical Study Site
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Milan, Italien, 20141
- Rekruttering
- Clinical Study Site
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Milan, Italien, 20133
- Rekruttering
- Clinical Study Site
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Orbassano, Italien, 10043
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- Clinical Study Sites
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Parma, Italien, 43126
- Rekruttering
- Clinical Study Site
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Peschiera del Garda, Italien, 37019
- Rekruttering
- Clinical Study Site
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Rome, Italien, 00144
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- Clinical Study Site
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Italy
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Rome, Italy, Italien, 00189
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- Clinical Study Site
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Sakai, Japan, 591-8555
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- Clinical Study Site
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 460-0001
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- Clinical Study Site
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
- Rekruttering
- Clinical Study Site
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Hokkaido
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Asahikawa, Hokkaido, Japan, 078-8510
- Rekruttering
- Clinical Study Site
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Hyōgo
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Nishinomiya, Hyōgo, Japan, 663-8501
- Rekruttering
- Clinical Study Site
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Rekruttering
- Clinical Study Site
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Japan
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Tokyo, Japan, Japan, 104-0045
- Rekruttering
- Clinical Study Site
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Kumamoto
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Kumamoto, Kumamoto, Japan, 861-4193
- Rekruttering
- Clinical Study Site
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Kyoto
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Kyoto, Kyoto, Japan, 602-8566
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- Clinical Study Sites
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Mie-ken
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Matsusaka, Mie-ken, Japan, 515-8544
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- Clinical Study Site
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
- Rekruttering
- Clinical Study Site
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Nagasaki
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Omura-shi, Nagasaki, Japan, 856-8562
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- Clinical Study Site
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Okayama-ken
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Okayama, Okayama-ken, Japan, 700-8558
- Rekruttering
- Clinical Study Site
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Osaka
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Hirakata, Osaka, Japan, 573-1191
- Rekruttering
- Clinical Study Site
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Osaka, Osaka, Japan, 541-8567
- Rekruttering
- Clinical Study Site
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Saitama
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Hidaka, Saitama, Japan, 350-1298
- Rekruttering
- Clinical Study Site
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Tochigi
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Shimotsuke, Tochigi, Japan, 329-0498
- Rekruttering
- Clinical Study Site
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Tokyo
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Bunkyō-Ku, Tokyo, Japan, 113-8677
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- Clinical Study Site
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Koto-Ku, Tokyo, Japan, 135-8550
- Rekruttering
- Clinical Study Site
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Wakayama
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Wakayama, Wakayama, Japan, 641-8510
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- Clinical Study Site
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Beijing, Kina
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- Clinical Study Site
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Shanghai, Kina
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- Clinical Study Site
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Tianjin, Kina
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- Clinical Study Sites
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Anhui
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Fuyang, Anhui, Kina
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- Clinical Study Site
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Beijing Municipality
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Beijing, Beijing Municipality, Kina
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- Clinical Study Site
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Fujian
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Fuzhou, Fujian, Kina
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- Clinical Study Site
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Guangdong
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Guangzhou, Guangdong, Kina
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- Clinical Study Site
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Guangxi
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Nanning, Guangxi, Kina
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- Clinical Study Site
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Guizhou
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Guiyang, Guizhou, Kina
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- Clinical Study Site
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Hainan
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Haikou, Hainan, Kina
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- Clinical Study Site
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150081
- Rekruttering
- Clinical Study Site
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Henan
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Luoyang, Henan, Kina
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- Clinical Study Site
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Nanyang, Henan, Kina
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- Clinical Study Site
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Zhengzhou, Henan, Kina
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- Clinical Study Site
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Hunan
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Changsha, Hunan, Kina
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- Clinical Study Site
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Zhuzhou, Hunan, Kina
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- Clinical Study Site
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Inner Mongolia
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Hohhot, Inner Mongolia, Kina
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- Clinical Study Site
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Jiangsu
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Changzhou, Jiangsu, Kina
- Rekruttering
- Clinical Site Study
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Jiangxi
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Ganzhou, Jiangxi, Kina
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- Clinical Study Site
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Nanchang, Jiangxi, Kina
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- Clinical Study Site
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Jilin
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Changchun, Jilin, Kina
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- Clinical Study Site
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Liaoning
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Shenyang, Liaoning, Kina
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- Clinical Study Site
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Shandong
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Jinan, Shandong, Kina
- Rekruttering
- Clinical Study Site
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Qingdao, Shandong, Kina
- Rekruttering
- Clinical Study Site
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Tai’an, Shandong, Kina
- Rekruttering
- Clinical Study Site
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Weifang, Shandong, Kina
- Rekruttering
- Clinical Study Site
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Shanxi
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Xi’an, Shanxi, Kina
- Rekruttering
- Clinical Study Site
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Sichuan
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Chengdu, Sichuan, Kina
- Rekruttering
- Clinical Study Site
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Luzhou, Sichuan, Kina
- Rekruttering
- Clinical Study Site
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Xinxiang
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Weihui, Xinxiang, Kina
- Rekruttering
- Clinical Study Site
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Yunnan
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Kunming, Yunnan, Kina
- Rekruttering
- Clinical Study Site
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Zhejiang
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Hangzhou, Zhejiang, Kina
- Rekruttering
- Clinical Study Site
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Taizhou, Zhejiang, Kina
- Rekruttering
- Clinical Study Site
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Wenzhou, Zhejiang, Kina
- Rekruttering
- Clinical Site Study
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Aguascalientes, Mexico, 20124
- Rekruttering
- Clinical Study site
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Guadalajara, Mexico, 44670
- Rekruttering
- Clinical Study Site
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Guadalajara, Mexico, 44680
- Rekruttering
- Clinical Study Site
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Jalisco, Mexico, 44680
- Rekruttering
- Clinical Study Site
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Mexico City, Mexico, 06700
- Rekruttering
- Clinical Study Site
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Mexico City, Mexico, 10200
- Rekruttering
- Clinical Study Sites
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Mexico City, Mexico, 14080
- Rekruttering
- Clinical Study Site
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Mexico City, Mexico, 03240
- Rekruttering
- Clinical Study Site
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Monterrey, Mexico, 64710
- Rekruttering
- Clinical Study Site
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Veracruz, Mexico, 91900
- Rekruttering
- Clinical Study Site
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Veracruz, Mexico, 20124
- Rekruttering
- Clinical Study site
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Aguascalientes
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Aguascalientes, Aguascalientes, Mexico, 20124
- Rekruttering
- Clinical Study Site
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Jalisco
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Guadalajara, Jalisco, Mexico, 44620
- Rekruttering
- Clinical Study site
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Mexico City
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Querétaro, Mexico City, Mexico, 76269
- Rekruttering
- Clinical Study Site
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Oaxaca
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Oaxaca City, Oaxaca, Mexico, 68020
- Rekruttering
- Clinical Study Site
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Gdansk, Polen, 80214
- Rekruttering
- Clinical Study Site
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Lodz, Polen, 93338
- Rekruttering
- Clinical Study Site
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Lublin, Polen, 20064
- Rekruttering
- Clinical Study Site
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Poznan, Polen, 60693
- Rekruttering
- Clinical Study Site
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Skorzewo, Polen, 60185
- Rekruttering
- Clinical Study Site
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Coimbra, Portugal, 3020-479
- Rekruttering
- Clinical Study Site
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Faro, Portugal, 8000-386
- Rekruttering
- Clinical Study Site
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Porto, Portugal, 4099-001
- Rekruttering
- Clinical Study Site
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Braga District
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Braga, Braga District, Portugal, 4710-243
- Rekruttering
- Clinical Study Site
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Lisban
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Lisbon, Lisban, Portugal, 1400-038
- Rekruttering
- Clinical Study Site
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Portugal
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Porto, Portugal, Portugal, 4200-072
- Rekruttering
- Clinical Study Site
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Bucharest, Rumænien, 022328
- Rekruttering
- Clinical Study Site
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Cluj
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Cluj-Napoca, Cluj, Rumænien, 400015
- Rekruttering
- Clinical Study Site
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Cluj-Napoca, Cluj, Rumænien, 400641
- Rekruttering
- Clinical Study Site
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Cluj-Napoca, Cluj, Rumænien, 407280
- Rekruttering
- Clinical Study Site
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Suceagu, Cluj, Rumænien, 407062
- Rekruttering
- Clinical Study Site
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Constanța County
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Ovidiu, Constanța County, Rumænien, 905900
- Rekruttering
- Clinical Study Site
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Dolj
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Craiova, Dolj, Rumænien, 200542
- Rekruttering
- Clinical Study Site
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Iaşi
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Iași, Iaşi, Rumænien, 700106
- Rekruttering
- Clinical Study Site
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Maramureş
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Baia Mare, Maramureş, Rumænien, 430031
- Rekruttering
- Clinical Study Site
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Timiș County
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Timișoara, Timiș County, Rumænien, 300166
- Rekruttering
- Clinical Study Site
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Timișoara, Timiș County, Rumænien, 300425
- Rekruttering
- Clinical Study Site
-
-
-
-
-
Belgrade, Serbien, 11080
- Rekruttering
- Clinical Study Site
-
Belgrade, Serbien, 11040
- Rekruttering
- Clinical Study Site
-
Kragujevac, Serbien, 34000
- Rekruttering
- Clinical Study Site
-
Novi Sad, Serbien, 21204
- Rekruttering
- Clinical Study Site
-
-
-
-
-
A Coruña, Spanien, 15006
- Rekruttering
- Clinical Study Site
-
Badalona, Spanien, 08916
- Rekruttering
- Clinical Study Site
-
Burgos, Spanien, 09006
- Rekruttering
- Clinical Study Site
-
Girona, Spanien, 17007
- Rekruttering
- Clinical Study Site
-
Lugo, Spanien, 27002
- Rekruttering
- Clinical Study Site
-
Málaga, Spanien, 29011
- Rekruttering
- Clinical Study Site
-
Seville, Spanien, 41014
- Rekruttering
- Clinical Study Site
-
Valencia, Spanien, 46026
- Rekruttering
- Clinical Study Site
-
Valencia, Spanien, 46010
- Rekruttering
- Clinical Study Site
-
Valladolid, Spanien, 47003
- Rekruttering
- Clinical Study Site
-
Zaragoza, Spanien, 50009
- Rekruttering
- Clinical Study Site
-
-
Bizkaia
-
Barakaldo, Bizkaia, Spanien, 48903
- Rekruttering
- Clinical Study Site
-
-
Cantabria
-
Santander, Cantabria, Spanien, 39008
- Rekruttering
- Clinical Study Site
-
-
Extremadura
-
Badajoz, Extremadura, Spanien, 06080
- Rekruttering
- Clinical Study Site
-
-
Las Palmas
-
Las Palmas, Las Palmas, Spanien, 35016
- Rekruttering
- Clinical Study Site
-
-
Madrid
-
Madrid, Madrid, Spanien, 28040
- Rekruttering
- Clinical Study Site
-
Madrid, Madrid, Spanien, 28007
- Rekruttering
- Clinical Study Site
-
Sevilla, Madrid, Spanien, 41014
- Rekruttering
- Clinical Study Site
-
-
Malaga
-
Marbella, Malaga, Spanien, 29660
- Rekruttering
- Clinical Study Site
-
-
Martin Lagos
-
Madrid, Martin Lagos, Spanien, 28040
- Rekruttering
- Clinical Study Site
-
-
Seville
-
Seville, Seville, Spanien, 41009
- Rekruttering
- Clinical Study Site
-
-
Spain
-
Barcelona, Spain, Spanien, 08003
- Rekruttering
- Clinical Study Site
-
Barcelona, Spain, Spanien, 08908
- Rekruttering
- Clinical Study Site
-
Madrid, Spain, Spanien, 28034
- Rekruttering
- Clinical Study Site
-
Madrid, Spain, Spanien, 28041
- Rekruttering
- Clinical Study Site
-
-
-
-
-
Adana, Tyrkiet (Türkiye), 01230
- Rekruttering
- Clinical Study Site
-
Ankara, Tyrkiet (Türkiye), 06520
- Rekruttering
- Clinical Study Site
-
Ankara, Tyrkiet (Türkiye), 06010
- Rekruttering
- Clinical Study Site
-
Ankara, Tyrkiet (Türkiye), 06230
- Rekruttering
- Clinical Study Site
-
Ankara, Tyrkiet (Türkiye), 06590
- Rekruttering
- Clinical Study Site
-
Antalya, Tyrkiet (Türkiye), 07059
- Rekruttering
- Clinical Study Site
-
Diyarbakır, Tyrkiet (Türkiye), 21280
- Rekruttering
- Clinical Study Site
-
Gaziantep, Tyrkiet (Türkiye), 27060
- Rekruttering
- Clinical Study Site
-
Istanbul, Tyrkiet (Türkiye), 34722
- Rekruttering
- Clinical Study Site
-
Istanbul, Tyrkiet (Türkiye), 34460
- Rekruttering
- Clinical Study Site
-
Istanbul, Tyrkiet (Türkiye), 34098
- Rekruttering
- Clinical Study Site
-
Izmir, Tyrkiet (Türkiye), 35100
- Rekruttering
- Clinical Study Site
-
Konya, Tyrkiet (Türkiye), 42080
- Rekruttering
- Clinical Study Site
-
Seyhan, Tyrkiet (Türkiye), 01140
- Rekruttering
- Clinical Study Site
-
İzmit, Tyrkiet (Türkiye), 41380
- Rekruttering
- Clinical Study Site
-
-
Bahcelievler
-
Istanbul, Bahcelievler, Tyrkiet (Türkiye), 34180
- Rekruttering
- Clinical Study Site
-
-
Yenimahalle
-
Ankara, Yenimahalle, Tyrkiet (Türkiye), 06200
- Rekruttering
- Clinical Study Site
-
-
-
-
-
Chemnitz, Tyskland, 09116
- Rekruttering
- Clinical Study Site
-
Esslingen am Neckar, Tyskland, 73701
- Rekruttering
- Clinical Study Sites
-
Gauting, Tyskland, 82131
- Rekruttering
- Clinical Study Site
-
Giesen, Tyskland, 35392
- Rekruttering
- Clinical Study Site
-
Halle, Tyskland, 06120
- Rekruttering
- Clinical Study Site
-
Herne, Tyskland, 44651
- Rekruttering
- Clinical Study Site
-
Karlsruhe, Tyskland, 76137
- Rekruttering
- Clinical Study Site
-
Minden, Tyskland, 32429
- Rekruttering
- Clinical Study Site
-
Möser, Tyskland, 47441
- Rekruttering
- Clinical Study Site
-
-
-
-
-
Budapest, Ungarn, 01121
- Rekruttering
- Clinical Study Site
-
Budapest, Ungarn, 01122
- Rekruttering
- Clinical Study Site
-
Gyula, Ungarn, 05700
- Rekruttering
- Clinical Study Site
-
Gyöngyös, Ungarn, 03200
- Rekruttering
- Clinical Study Site
-
Kecskemét, Ungarn, 06000
- Rekruttering
- Clinical Study Site
-
-
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
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:
- Age ≥ 18 years old at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
- Expected life expectancy ≥ 3 months
- Metastatic (Stage IV) NSCLC
- Histologically or cytologically confirmed squamous or non-squamous NSCLC
- Tumor demonstrates high PD-L1 expression ( TPS>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
- At least one measurable noncerebral lesion according to RECIST 1.1
- No prior systemic treatment for metastatic NSCLC.
Exclusion Criteria:
- Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
- Has received any prior therapy for NSCLC in the metastatic setting.
- Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
- Known actionable genomic alterations for which first-line approved therapies are indicated
- Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
- Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
- Active autoimmune or lung disease requiring systemic therapy
- Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
- Severe infection within 4 weeks prior to randomization
- Major surgical procedures or serious trauma within 4 weeks prior to randomization
- History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm A - Ivonescimab
Subject will receive ivonescimab as an IV injection |
Subject will receive ivonescimab as an IV injection |
|
Aktiv komparator: Arm B - Pembrolizumab
Subject will receive pembrolizumab as an IV injection |
Subject will receive Pembrolizumab as an IV injection |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Samlet overlevelse (OS)
Tidsramme: Op til cirka 36 måneder
|
Op til cirka 36 måneder
|
|
Progressionsfri overlevelse (PFS)
Tidsramme: Op til cirka 36 måneder
|
Op til cirka 36 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Objektiv svarprocent (ORR)
Tidsramme: Op til cirka 36 måneder
|
Op til cirka 36 måneder
|
|
Disease control rate (DCR)
Tidsramme: Op til cirka 36 måneder
|
Op til cirka 36 måneder
|
|
Varighed af svar (DoR)
Tidsramme: Op til cirka 36 måneder
|
Op til cirka 36 måneder
|
|
Bivirkninger (AE): forekomst og sværhedsgrad af bivirkninger (AE'er) og klinisk signifikante abnorme laboratorietestresultater
Tidsramme: [Tidsramme: Fra forsøgspersonen underskriver ICF til 30 dage (AE) og 90 dage (SAE relateret til ivonescimab/pembrolizumab) efter den sidste dosis af undersøgelsesbehandling eller påbegyndelse af anden anticancerbehandling, alt efter hvad der indtræffer først, Op til ca. 24 måneder .
|
[Tidsramme: Fra forsøgspersonen underskriver ICF til 30 dage (AE) og 90 dage (SAE relateret til ivonescimab/pembrolizumab) efter den sidste dosis af undersøgelsesbehandling eller påbegyndelse af anden anticancerbehandling, alt efter hvad der indtræffer først, Op til ca. 24 måneder .
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
27. februar 2025
Primær færdiggørelse (Anslået)
1. april 2028
Studieafslutning (Anslået)
1. juni 2029
Datoer for studieregistrering
Først indsendt
3. januar 2025
Først indsendt, der opfyldte QC-kriterier
8. januar 2025
Først opslået (Faktiske)
10. januar 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SMT112-3007
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 .