Et globalt fase III-studie af Rilvegostomig eller Pembrolizumab Plus kemoterapi til førstelinjebehandling af metastatisk ikke-småcellet lungekræft (NSCLC)
28. oktober 2026 opdateret af: AstraZeneca
Et fase III, randomiseret, dobbeltblindt, multicenter, globalt studie af Rilvegostomig eller Pembrolizumab i kombination med platinbaseret kemoterapi til førstelinjebehandling af patienter med metastatisk planocellulær ikke-småcellet lungekræft, hvis tumorer udtrykker PD-L1 (ARTEMIDE) -Lunge02)
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
1160
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Studiesteder
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Buenos Aires, Argentina, C1431FWO
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CABA, Argentina, 1425
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La Plata, Argentina, 1900
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Pilar, Argentina, B1629ODT
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Rosario, Argentina, S2000DEJ
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Darlinghurst, Australien, 2010
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Hyde Park, Australien, 4812
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Southport, Australien, 4215
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Wollongong, Australien, 2500
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Anderlecht, Belgien, 1070
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Brussels, Belgien, 1160
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Charleroi, Belgien, 6060
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Kortrijk, Belgien, 8500
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Ottignies, Belgien, 1340
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Sint-Niklaas, Belgien, 9100
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Barretos, Brasilien, 14784-400
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Florianópolis, Brasilien, 88034-000
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Ijuí, Brasilien, 98700-000
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Londrina, Brasilien, 86015-520
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Porto Alegre, Brasilien, 91350-200
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Salvador, Brasilien, 40050 410
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São Paulo, Brasilien, 01246-000
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São Paulo, Brasilien, 05652-900
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Taubaté, Brasilien, 12030-200
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 4L2
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Nova Scotia
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Sydney, Nova Scotia, Canada, B1P 1P3
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Ontario
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Greater Sudbury, Ontario, Canada, P3E 5J1
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Hamilton, Ontario, Canada, L8V 1C3
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Sault Ste. Marie, Ontario, Canada, P6A 0A8
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
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Montreal, Quebec, Canada, H2X 0A9
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Aberdeen, Det Forenede Kongerige, AB25 2ZN
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Cambridge, Det Forenede Kongerige, CB2 0QQ
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Edinburgh, Det Forenede Kongerige, EH4 2XU
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Exeter, Det Forenede Kongerige, EX2 5DW
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Greater London, Det Forenede Kongerige, SW3 6JJ
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London, Det Forenede Kongerige, EC1A 7BE
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London, Det Forenede Kongerige, SE1 9RT
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Manchester, Det Forenede Kongerige, M20 4BX
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7AF
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Preston, Det Forenede Kongerige, PR2 9HT
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
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Arkansas
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Springdale, Arkansas, Forenede Stater, 72762
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California
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Anaheim, California, Forenede Stater, 92801
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Beverly Hills, California, Forenede Stater, 90211
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Loma Linda, California, Forenede Stater, 92354
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Los Alamitos, California, Forenede Stater, 90720
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Redlands, California, Forenede Stater, 92373
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San Francisco, California, Forenede Stater, 94121
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Walnut Creek, California, Forenede Stater, 94598
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Connecticut
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West Haven, Connecticut, Forenede Stater, 06516
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Delaware
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Newark, Delaware, Forenede Stater, 19713
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Florida
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Bay Pines, Florida, Forenede Stater, 33744
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Fort Lauderdale, Florida, Forenede Stater, 33308
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Gainesville, Florida, Forenede Stater, 32610
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Gainesville, Florida, Forenede Stater, 32608
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Jacksonville, Florida, Forenede Stater, 32224
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Georgia
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Athens, Georgia, Forenede Stater, 30607
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Atlanta, Georgia, Forenede Stater, 30341
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Savannah, Georgia, Forenede Stater, 31404
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Idaho
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Boise, Idaho, Forenede Stater, 83712
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Illinois
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Chicago, Illinois, Forenede Stater, 60637
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Decatur, Illinois, Forenede Stater, 62526
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Hinsdale, Illinois, Forenede Stater, 60521
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Quincy, Illinois, Forenede Stater, 62301
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Rockford, Illinois, Forenede Stater, 61114
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46845
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Iowa
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Waterloo, Iowa, Forenede Stater, 50702
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40509
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Lexington, Kentucky, Forenede Stater, 40536
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Louisville, Kentucky, Forenede Stater, 40207
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Louisville, Kentucky, Forenede Stater, 40202
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Louisiana
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Alexandria, Louisiana, Forenede Stater, 71301
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Baton Rouge, Louisiana, Forenede Stater, 70808
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Covington, Louisiana, Forenede Stater, 70433
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Shreveport, Louisiana, Forenede Stater, 71105
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Shreveport, Louisiana, Forenede Stater, 71103
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Maine
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Scarborough, Maine, Forenede Stater, 04074
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Maryland
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Baltimore, Maryland, Forenede Stater, 21202
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Bethesda, Maryland, Forenede Stater, 20817
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Bethesda, Maryland, Forenede Stater, 20889
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
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Grand Rapids, Michigan, Forenede Stater, 49503
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Saginaw, Michigan, Forenede Stater, 48602
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55802
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Rochester, Minnesota, Forenede Stater, 55905
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Missouri
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Bridgeton, Missouri, Forenede Stater, 63044
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Columbia, Missouri, Forenede Stater, 65212
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Kansas City, Missouri, Forenede Stater, 64108
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68506
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New Jersey
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Camden, New Jersey, Forenede Stater, 08103
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New York
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Buffalo, New York, Forenede Stater, 14221
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East Syracuse, New York, Forenede Stater, 13057
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Westbury, New York, Forenede Stater, 11590
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North Carolina
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Wilson, North Carolina, Forenede Stater, 27893
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North Dakota
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Grand Forks, North Dakota, Forenede Stater, 58201
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45267
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Oregon
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Bend, Oregon, Forenede Stater, 97701
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Medford, Oregon, Forenede Stater, 97504
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Salem, Oregon, Forenede Stater, 97301
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Pennsylvania
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Hershey, Pennsylvania, Forenede Stater, 17033
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York, Pennsylvania, Forenede Stater, 17403
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
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Nashville, Tennessee, Forenede Stater, 37203
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Texas
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Fort Worth, Texas, Forenede Stater, 76104
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Houston, Texas, Forenede Stater, 77090
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Kingwood, Texas, Forenede Stater, 77339
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Lubbock, Texas, Forenede Stater, 79410
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Round Rock, Texas, Forenede Stater, 78665
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
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Fredericksburg, Virginia, Forenede Stater, 22408
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Washington
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Olympia, Washington, Forenede Stater, 98506
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Seattle, Washington, Forenede Stater, 98101
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Silverdale, Washington, Forenede Stater, 98383
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Spokane, Washington, Forenede Stater, 99208
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Tacoma, Washington, Forenede Stater, 98405
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Wenatchee, Washington, Forenede Stater, 98801
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Avignon, Frankrig, 84902
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La Rochelle, Frankrig, 17019
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Lyon, Frankrig, 69008
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Nîmes, Frankrig, 30029
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Rennes, Frankrig, 35033
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Strasbourg, Frankrig, 67091
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Suresnes, Frankrig, 92150
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Toulon, Frankrig, 83800
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Alkmaar, Holland, 1815 JD
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Ede, Holland, 6716 RP
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Groningen, Holland, 9713 GZ
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Leidschendam, Holland, 2262 BA
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Veldhoven, Holland, 5504 DB
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Zwolle, Holland, 8025 AB
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Calicut, Indien, 673601
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Delhi, Indien, 110029
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Gūrgaon, Indien, 122001
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Kolkata, Indien, 700054
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Madurai, Indien, 625107
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Mumbai, Indien, 400012
- Ikke rekrutterer endnu
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Nagpur, Indien, 440001
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Nashik, Indien, 422002
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New Delhi, Indien, 110075
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Puducherry, Indien, 605006
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Surat, Indien, 395017
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Varanasi, Indien, 221005
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Florence, Italien, 50134
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Legnano, Italien, 20025
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Livorno, Italien, 57126
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Monza, Italien, 20900
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Orbassano, Italien, 10043
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Padova, Italien, 35128
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Peschiera del Garda, Italien, 37019
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Roma, Italien, 00168
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Amagasaki-shi, Japan, 660-8550
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Bunkyō City, Japan, 113-8603
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Chūōku, Japan, 104-0045
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Fukuoka, Japan, 812-8582
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Fukuoka, Japan, 814-0180
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Hirakata-shi, Japan, 573-1191
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Hiroshima, Japan, 734-8551
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Kakogawa-shi, Japan, 675-8611
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Kanazawa, Japan, 920-8530
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Kawagoe-shi, Japan, 350-8550
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Kawasaki-shi, Japan, 216-8511
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Kitaadachi-gun, Japan, 362-0806
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Kitakyushu-shi, Japan, 807-8555
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Kiyose-shi, Japan, 204-8522
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Kobe, Japan, 650-0017
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Kumamoto, Japan, 861-4193
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Kumamoto, Japan, 860-8556
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Kyoto, Japan, 612-8555
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Kōtoku, Japan, 135-8550
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Matsusaka-shi, Japan, 515-8544
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Obihiro-shi, Japan, 080-0024
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Osaka, Japan, 541-8567
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Ota-shi, Japan, 373-8550
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Saitama-shi, Japan, 338-0001
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Sakai, Japan, 590-0197
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Sapporo, Japan, 006-8555
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Sendai, Japan, 981-0914
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Shinjuku-ku, Japan, 160-0023
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Takaoka-shi, Japan, 933-8555
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Yokohama, Japan, 241-8515
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Yokohama, Japan, 232-0024
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Beijing, Kina, 100029
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Beijing, Kina, CN-100730
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Beijing, Kina, 100142
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Beijing, Kina, 100021
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Beijing, Kina, 101149
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Changchun, Kina, 130012
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Changde, Kina, 415000
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Changsha, Kina, 410013
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Chengdu, Kina, 610041
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Chengdu, Kina, 610072
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Chongqing, Kina, 400030
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Dalian, Kina, 116001
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Guangzhou, Kina, 510062
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Guangzhou, Kina, 510100
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Hangzhou, Kina, 310003
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Hangzhou, Kina, 310022
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Hangzhou, Kina, 310016
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Harbin, Kina, 150081
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Hefei, Kina, 230601
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Hefei, Kina, 230001
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Jinan, Kina, 250117
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Kunming, Kina, 650118
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Linhai, Kina, 317000
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Linyi, Kina, 276001
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Nanchang, Kina, 330008
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Ningbo, Kina, 315010
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Shanghai, Kina, 200032
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Shanghai, Kina, 200030
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Shanghai, Kina, 200433
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Shenyang, Kina, 110004
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Shenzhen, Kina, 518020
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Taiyuan, Kina, 030000
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Tianjin, Kina, 300050
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Wenzhou, Kina, CN-325000
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Wuhan, Kina, 430030
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Xi'an, Kina, 710061
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Yangzhou, Kina, 225001
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Yueyang, Kina, 414000
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Zhengzhou, Kina, 450008
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Zhengzhou, Kina, 450052
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George Town, Malaysia, 10450
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Johor Bahru, Malaysia, 81100
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Kuala Lumpur, Malaysia, 59100
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Lima, Peru, L27
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Lima, Peru, 15036
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Lima, Peru, LIMA 29
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Lima, Peru, 15102
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Lima, Peru, 34
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Lima, Peru, Lima39
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Bialystok, Polen, 15-027
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Biała Podlaska, Polen, 21-500
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Bydgoszcz, Polen, 85-796
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Bystra, Polen, 43-360
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Lodz, Polen, 93-338
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Lublin, Polen, 20-090
- Ikke rekrutterer endnu
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Poznan, Polen, 60-569
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Warsaw, Polen, 04-141
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Wroclaw, Polen, 53-413
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San Juan, Puerto Rico, 00918
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San Juan, Puerto Rico, 00909
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Almería, Spanien, 04009
- Ikke rekrutterer endnu
- Research Site
-
Barcelona, Spanien, 8035
- Rekruttering
- Research Site
-
Las Palmas de Gran Canaria, Spanien, 35016
- Rekruttering
- Research Site
-
Lleida, Spanien, 25198
- Rekruttering
- Research Site
-
Madrid, Spanien, 28007
- Rekruttering
- Research Site
-
Madrid, Spanien, 28034
- Rekruttering
- Research Site
-
Majadahonda, Spanien, 28222
- Rekruttering
- Research Site
-
Seville, Spanien, 41013
- Rekruttering
- Research Site
-
-
-
-
-
Changwon-si, Sydkorea, 51353
- Rekruttering
- Research Site
-
Cheongju-si, Sydkorea, 28644
- Rekruttering
- Research Site
-
Incheon, Sydkorea, 21565
- Rekruttering
- Research Site
-
JinJoo, Sydkorea, 52727
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 03080
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 06351
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 05505
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 03722
- Rekruttering
- Research Site
-
Suwon, Sydkorea, 16247
- Rekruttering
- Research Site
-
Suwon, Sydkorea, 16499
- Rekruttering
- Research Site
-
-
-
-
-
Kaohsiung City, Taiwan, 80756
- Rekruttering
- Research Site
-
Kaohsiung City, Taiwan, 824
- Rekruttering
- Research Site
-
New Taipei City, Taiwan, 220
- Rekruttering
- Research Site
-
New Taipei City, Taiwan, 23561
- Rekruttering
- Research Site
-
Taichung, Taiwan, 40705
- Rekruttering
- Research Site
-
Taichung, Taiwan, 402
- Rekruttering
- Research Site
-
Tainan, Taiwan, 73657
- Rekruttering
- Research Site
-
Taoyuan, Taiwan, 333
- Rekruttering
- Research Site
-
-
-
-
-
Bangkok, Thailand, 10700
- Rekruttering
- Research Site
-
Chiang Mai, Thailand, 50200
- Rekruttering
- Research Site
-
Dusit, Thailand, 10300
- Rekruttering
- Research Site
-
Nakhon Ratchasima, Thailand, 30000
- Rekruttering
- Research Site
-
Songkhla, Thailand, 90110
- Rekruttering
- Research Site
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 6500
- Rekruttering
- Research Site
-
Antalya, Tyrkiet (Türkiye), 07059
- Rekruttering
- Research Site
-
Istanbul, Tyrkiet (Türkiye), 34098
- Rekruttering
- Research Site
-
Yenimahalle, Tyrkiet (Türkiye), 06170
- Rekruttering
- Research Site
-
-
-
-
-
Bad Berka, Tyskland, 99437
- Rekruttering
- Research Site
-
Berlin, Tyskland, 13125
- Trukket tilbage
- Research Site
-
Berlin, Tyskland, 13585
- Trukket tilbage
- Research Site
-
Bielefeld, Tyskland, 33611
- Ikke rekrutterer endnu
- Research Site
-
Bochum, Tyskland, 44791
- Ikke rekrutterer endnu
- Research Site
-
Chemnitz, Tyskland, 09116
- Ikke rekrutterer endnu
- Research Site
-
Cologne, Tyskland, 51109
- Rekruttering
- Research Site
-
Cologne, Tyskland, 50677
- Ikke rekrutterer endnu
- Research Site
-
Essen, Tyskland, 45136
- Ikke rekrutterer endnu
- Research Site
-
Esslingen am Neckar, Tyskland, 73730
- Rekruttering
- Research Site
-
Frankfurt, Tyskland, 60488
- Rekruttering
- Research Site
-
Frankfurt am Main, Tyskland, 60431
- Rekruttering
- Research Site
-
Gauting, Tyskland, 82131
- Rekruttering
- Research Site
-
Giessen, Tyskland, 35392
- Rekruttering
- Research Site
-
Großhansdorf, Tyskland, 22927
- Rekruttering
- Research Site
-
Halle, Tyskland, 06120
- Ikke rekrutterer endnu
- Research Site
-
Hamburg, Tyskland, 20251
- Rekruttering
- Research Site
-
Hamburg, Tyskland, 22087
- Ikke rekrutterer endnu
- Research Site
-
Hanover, Tyskland, 30625
- Rekruttering
- Research Site
-
Hanover, Tyskland, 30459
- Rekruttering
- Research Site
-
Heidelberg, Tyskland, 69126
- Rekruttering
- Research Site
-
Hemer, Tyskland, 58675
- Rekruttering
- Research Site
-
Homburg, Tyskland, 66424
- Rekruttering
- Research Site
-
Kassel, Tyskland, 34125
- Rekruttering
- Research Site
-
Kiel, Tyskland, 24105
- Rekruttering
- Research Site
-
Krefeld, Tyskland, 47805
- Rekruttering
- Research Site
-
Magdeburg, Tyskland, 39120
- Ikke rekrutterer endnu
- Research Site
-
Minden, Tyskland, 32429
- Rekruttering
- Research Site
-
Moers, Tyskland, 47441
- Rekruttering
- Research Site
-
München, Tyskland, 81925
- Rekruttering
- Research Site
-
Oldenburg i.H., Tyskland, 23758
- Ikke rekrutterer endnu
- Research Site
-
Regensburg, Tyskland, 93053
- Rekruttering
- Research Site
-
Schwerin, Tyskland, 19049
- Ikke rekrutterer endnu
- Research Site
-
Velbert, Tyskland, 42551
- Ikke rekrutterer endnu
- Research Site
-
Würzburg, Tyskland, 97067
- Rekruttering
- Research Site
-
-
-
-
-
Budapest, Ungarn, 1121
- Rekruttering
- Research Site
-
Budapest, Ungarn, 1083
- Rekruttering
- Research Site
-
Budapest, Ungarn, 1122
- Rekruttering
- Research Site
-
Debrecen, Ungarn, 4032
- Rekruttering
- Research Site
-
Edelény, Ungarn, 3780
- Ikke rekrutterer endnu
- Research Site
-
Gyöngyös, Ungarn, 3200
- Trukket tilbage
- Research Site
-
Gyöngyös - Mátraháza, Ungarn, 3200
- Rekruttering
- Research Site
-
Győr, Ungarn, 9024
- Rekruttering
- Research Site
-
Pécs, Ungarn, 7624
- Rekruttering
- Research Site
-
Székesfehérvár, Ungarn, 8000
- Suspenderet
- Research Site
-
Törökbálint, Ungarn, 2045
- Rekruttering
- Research Site
-
-
-
-
-
Can Tho, Vietnam, 900000
- Rekruttering
- Research Site
-
Hanoi, Vietnam, 100000
- Rekruttering
- Research Site
-
Ho Chi Minh City, Vietnam, 700000
- Rekruttering
- Research Site
-
Vinh, Vietnam, 460000
- Rekruttering
- Research Site
-
-
-
-
-
Innsbruck, Østrig, 6020
- Rekruttering
- Research Site
-
Krems, Østrig, 3500
- Rekruttering
- Research Site
-
Rankweil, Østrig, 6830
- Rekruttering
- Research Site
-
Vienna, Østrig, 1210
- Rekruttering
- Research Site
-
Vienna, Østrig, 1160
- Rekruttering
- Research 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
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:
- Histologically or cytologically documented squamous NSCLC.
- Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
- Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved and available targeted 1L therapies.
- Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.
- At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
- Adequate organ and bone marrow function.
Exclusion Criteria:
- Presence of small cell and neuroendocrine histology components.
- Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
- Any prior systemic, non-curative therapy received for NSCLC.
- Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
- Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs.
- Active primary immunodeficiency/active infectious disease(s).
- Active tuberculosis infection.
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
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm A
Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig |
Administered intravenously (IV) on Day 1 of each 21-day cycle
Andre navne:
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles |
|
Aktiv komparator: Arm B
Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab |
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles Administered intravenously (IV) on Day 1 of each 21-day cycle
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival (OS)
Tidsramme: Up to approximately 6 years
|
OS is defined as the time from randomization until the date of death due to any cause. |
Up to approximately 6 years
|
|
Progression-free survival (PFS)
Tidsramme: Up to approximately 6 years
|
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression). |
Up to approximately 6 years
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Landmark overall survival (OS) rates
Tidsramme: Up to approximately 6 years
|
OS is defined as the time from randomization until the date of death due to any cause. |
Up to approximately 6 years
|
|
Landmark progression-free survival (PFS) rates
Tidsramme: Up to approximately 6 years
|
PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression). |
Up to approximately 6 years
|
|
Time to second progression or death (PFS2)
Tidsramme: Up to approximately 6 years
|
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice. |
Up to approximately 6 years
|
|
Overall response rate (ORR)
Tidsramme: Up to approximately 6 years
|
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). |
Up to approximately 6 years
|
|
Duration of response (DoR)
Tidsramme: Up to approximately 6 years
|
DoR is defined as the time from the date of first documented response until the date of documented progression using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression). |
Up to approximately 6 years
|
|
Pharmacokinetic (PK) of rilvegostomig
Tidsramme: Up to approximately 6 years
|
Concentration of rilvegostomig in serum. |
Up to approximately 6 years
|
|
Immunogenicity of rilvegostomig
Tidsramme: Up to approximately 6 years
|
Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig. |
Up to approximately 6 years
|
|
Patient-reported physical functioning
Tidsramme: Up to approximately 6 years
|
Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point. |
Up to approximately 6 years
|
|
Patient-reported global health status (GHS)/quality of life (QoL)
Tidsramme: Up to approximately 6 years
|
Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold. |
Up to approximately 6 years
|
|
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Tidsramme: Up to approximately 6 years
|
Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). TTD is defined as time from randomization to the date of first deterioration. |
Up to approximately 6 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
Studiestart
18. november 2024
Primær færdiggørelse (Anslået)
Primær færdiggørelse
1. juli 2030
Studieafslutning (Anslået)
Studieafslutning
1. juli 2030
Datoer for studieregistrering
Først indsendt
Først indsendt
4. oktober 2024
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
14. november 2024
Først opslået (Faktiske)
Først opslået
18. november 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
29. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. oktober 2026
Sidst verificeret
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Luftvejssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Karcinom, ikke-småcellet lunge
- Organiske kemikalier
- Kulbrinter
- Cycloparaffiner
- Kulbrinter, alicyklisk
- Kulbrinter, cyklisk
- Terpenes
- Koordinationskomplekser
- Taxoider
- Cyclodecanes
- Diterpenes
- Carboplatin
- Paclitaxel
- pembrolizumab
- 130-nm albuminbundet paclitaxel
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- D702BC00001
- 2024-514281-39-00 (Registry Identifier: CTIS (EU))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for Important Protocol Deviation (IPD), but this does not mean all requests will be approved.
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA)/Pharmaceutical Research and Manufacturers of America (PhRMA) Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD-delingsadgangskriterier
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
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 .