En global fase III-studie av Rilvegostomig eller Pembrolizumab Plus kjemoterapi for førstelinjebehandling av metastatisk plateepitel, ikke-småcellet lungekreft (NSCLC)
28. oktober 2026 oppdatert av: AstraZeneca
En fase III, randomisert, dobbeltblind, multisenter, global studie av Rilvegostomig eller Pembrolizumab i kombinasjon med platinabasert kjemoterapi for førstelinjebehandling av pasienter med metastatisk plateepitel, ikke-småcellet lungekreft hvis svulster uttrykker 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).
Studieoversikt
Status
Rekruttering
Forhold
Detaljert 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%).
Studietype
Intervensjonell
Registrering (Antatt)
1160
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: 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, Australia, 2010
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Hyde Park, Australia, 4812
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Southport, Australia, 4215
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Wollongong, Australia, 2500
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Anderlecht, Belgia, 1070
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Brussels, Belgia, 1160
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Charleroi, Belgia, 6060
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Kortrijk, Belgia, 8500
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Ottignies, Belgia, 1340
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Sint-Niklaas, Belgia, 9100
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Barretos, Brasil, 14784-400
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Florianópolis, Brasil, 88034-000
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Ijuí, Brasil, 98700-000
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Londrina, Brasil, 86015-520
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Porto Alegre, Brasil, 91350-200
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Salvador, Brasil, 40050 410
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São Paulo, Brasil, 01246-000
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São Paulo, Brasil, 05652-900
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Taubaté, Brasil, 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
- Har ikke rekruttert ennå
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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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Arizona
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Tucson, Arizona, Forente stater, 85724
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Arkansas
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Springdale, Arkansas, Forente stater, 72762
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California
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Anaheim, California, Forente stater, 92801
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Beverly Hills, California, Forente stater, 90211
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Loma Linda, California, Forente stater, 92354
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Los Alamitos, California, Forente stater, 90720
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Redlands, California, Forente stater, 92373
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San Francisco, California, Forente stater, 94121
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Walnut Creek, California, Forente stater, 94598
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Connecticut
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West Haven, Connecticut, Forente stater, 06516
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Delaware
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Newark, Delaware, Forente stater, 19713
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Florida
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Bay Pines, Florida, Forente stater, 33744
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Fort Lauderdale, Florida, Forente stater, 33308
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Gainesville, Florida, Forente stater, 32610
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Gainesville, Florida, Forente stater, 32608
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Jacksonville, Florida, Forente stater, 32224
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Georgia
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Athens, Georgia, Forente stater, 30607
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Atlanta, Georgia, Forente stater, 30341
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Savannah, Georgia, Forente stater, 31404
- Har ikke rekruttert ennå
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Idaho
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Boise, Idaho, Forente stater, 83712
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Illinois
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Chicago, Illinois, Forente stater, 60637
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Decatur, Illinois, Forente stater, 62526
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Hinsdale, Illinois, Forente stater, 60521
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Quincy, Illinois, Forente stater, 62301
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Rockford, Illinois, Forente stater, 61114
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Indiana
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Fort Wayne, Indiana, Forente stater, 46845
- Har ikke rekruttert ennå
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Iowa
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Waterloo, Iowa, Forente stater, 50702
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Kentucky
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Lexington, Kentucky, Forente stater, 40509
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Lexington, Kentucky, Forente stater, 40536
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Louisville, Kentucky, Forente stater, 40207
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Louisville, Kentucky, Forente stater, 40202
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Louisiana
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Alexandria, Louisiana, Forente stater, 71301
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Baton Rouge, Louisiana, Forente stater, 70808
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Covington, Louisiana, Forente stater, 70433
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Shreveport, Louisiana, Forente stater, 71105
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Shreveport, Louisiana, Forente stater, 71103
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Maine
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Scarborough, Maine, Forente stater, 04074
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Maryland
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Baltimore, Maryland, Forente stater, 21202
- Fullført
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Bethesda, Maryland, Forente stater, 20817
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Bethesda, Maryland, Forente stater, 20889
- Har ikke rekruttert ennå
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Michigan
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Detroit, Michigan, Forente stater, 48202
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Grand Rapids, Michigan, Forente stater, 49503
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Saginaw, Michigan, Forente stater, 48602
- Har ikke rekruttert ennå
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Minnesota
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Duluth, Minnesota, Forente stater, 55802
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Rochester, Minnesota, Forente stater, 55905
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Missouri
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Bridgeton, Missouri, Forente stater, 63044
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Columbia, Missouri, Forente stater, 65212
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Kansas City, Missouri, Forente stater, 64108
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Nebraska
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Lincoln, Nebraska, Forente stater, 68506
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New Jersey
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Camden, New Jersey, Forente stater, 08103
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New York
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Buffalo, New York, Forente stater, 14221
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East Syracuse, New York, Forente stater, 13057
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Westbury, New York, Forente stater, 11590
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North Carolina
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Wilson, North Carolina, Forente stater, 27893
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North Dakota
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Grand Forks, North Dakota, Forente stater, 58201
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Ohio
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Cincinnati, Ohio, Forente stater, 45267
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Oregon
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Bend, Oregon, Forente stater, 97701
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Medford, Oregon, Forente stater, 97504
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Salem, Oregon, Forente stater, 97301
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Pennsylvania
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Hershey, Pennsylvania, Forente stater, 17033
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York, Pennsylvania, Forente stater, 17403
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South Dakota
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Sioux Falls, South Dakota, Forente stater, 57105
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
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Nashville, Tennessee, Forente stater, 37203
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Texas
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Fort Worth, Texas, Forente stater, 76104
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Houston, Texas, Forente stater, 77090
- Fullført
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Kingwood, Texas, Forente stater, 77339
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Lubbock, Texas, Forente stater, 79410
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Round Rock, Texas, Forente stater, 78665
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Virginia
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Fairfax, Virginia, Forente stater, 22031
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Fredericksburg, Virginia, Forente stater, 22408
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Washington
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Olympia, Washington, Forente stater, 98506
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Seattle, Washington, Forente stater, 98101
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Silverdale, Washington, Forente stater, 98383
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Spokane, Washington, Forente stater, 99208
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Tacoma, Washington, Forente stater, 98405
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Wenatchee, Washington, Forente stater, 98801
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Avignon, Frankrike, 84902
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La Rochelle, Frankrike, 17019
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Lyon, Frankrike, 69008
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Nîmes, Frankrike, 30029
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Rennes, Frankrike, 35033
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Strasbourg, Frankrike, 67091
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Suresnes, Frankrike, 92150
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Toulon, Frankrike, 83800
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Calicut, India, 673601
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Delhi, India, 110029
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Gūrgaon, India, 122001
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Kolkata, India, 700054
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Madurai, India, 625107
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Mumbai, India, 400012
- Har ikke rekruttert ennå
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Nagpur, India, 440001
- Har ikke rekruttert ennå
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Nashik, India, 422002
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New Delhi, India, 110075
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Puducherry, India, 605006
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Surat, India, 395017
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Varanasi, India, 221005
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Florence, Italia, 50134
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Legnano, Italia, 20025
- Har ikke rekruttert ennå
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Livorno, Italia, 57126
- Har ikke rekruttert ennå
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Monza, Italia, 20900
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Orbassano, Italia, 10043
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Padova, Italia, 35128
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Peschiera del Garda, Italia, 37019
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Roma, Italia, 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
- Har ikke rekruttert ennå
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Hiroshima, Japan, 734-8551
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Kakogawa-shi, Japan, 675-8611
- Har ikke rekruttert ennå
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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
- Rekruttering
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Kitakyushu-shi, Japan, 807-8555
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Kiyose-shi, Japan, 204-8522
- Har ikke rekruttert ennå
- Research Site
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Kobe, Japan, 650-0017
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Kumamoto, Japan, 861-4193
- Rekruttering
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Kumamoto, Japan, 860-8556
- Rekruttering
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Kyoto, Japan, 612-8555
- Rekruttering
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Kōtoku, Japan, 135-8550
- Rekruttering
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Matsusaka-shi, Japan, 515-8544
- Rekruttering
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Obihiro-shi, Japan, 080-0024
- Har ikke rekruttert ennå
- Research Site
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Osaka, Japan, 541-8567
- Rekruttering
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Ota-shi, Japan, 373-8550
- Rekruttering
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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
- Rekruttering
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Sendai, Japan, 981-0914
- Rekruttering
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Shinjuku-ku, Japan, 160-0023
- Rekruttering
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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
- Tilbaketrukket
- Research Site
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Beijing, Kina, CN-100730
- Rekruttering
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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
- Rekruttering
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Hefei, Kina, 230001
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Jinan, Kina, 250117
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Kunming, Kina, 650118
- Rekruttering
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Linhai, Kina, 317000
- Rekruttering
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Linyi, Kina, 276001
- Rekruttering
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Nanchang, Kina, 330008
- Rekruttering
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Ningbo, Kina, 315010
- Rekruttering
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Shanghai, Kina, 200032
- Rekruttering
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Shanghai, Kina, 200030
- Rekruttering
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Shanghai, Kina, 200433
- Rekruttering
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Shenyang, Kina, 110004
- Tilbaketrukket
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Shenzhen, Kina, 518020
- Tilbaketrukket
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Taiyuan, Kina, 030000
- Rekruttering
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Tianjin, Kina, 300050
- Rekruttering
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Wenzhou, Kina, CN-325000
- Rekruttering
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Wuhan, Kina, 430030
- Rekruttering
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Xi'an, Kina, 710061
- Rekruttering
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Yangzhou, Kina, 225001
- Rekruttering
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Yueyang, Kina, 414000
- Rekruttering
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Zhengzhou, Kina, 450008
- Rekruttering
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Zhengzhou, Kina, 450052
- Rekruttering
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George Town, Malaysia, 10450
- Rekruttering
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Johor Bahru, Malaysia, 81100
- Rekruttering
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Kuala Lumpur, Malaysia, 59100
- Rekruttering
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Alkmaar, Nederland, 1815 JD
- Rekruttering
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Ede, Nederland, 6716 RP
- Rekruttering
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Groningen, Nederland, 9713 GZ
- Tilbaketrukket
- Research Site
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Leidschendam, Nederland, 2262 BA
- Rekruttering
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Veldhoven, Nederland, 5504 DB
- Rekruttering
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Zwolle, Nederland, 8025 AB
- Rekruttering
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Lima, Peru, L27
- Tilbaketrukket
- Research Site
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Lima, Peru, 15036
- Tilbaketrukket
- Research Site
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Lima, Peru, LIMA 29
- Tilbaketrukket
- Research Site
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Lima, Peru, 15102
- Tilbaketrukket
- Research Site
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Lima, Peru, 34
- Tilbaketrukket
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Lima, Peru, Lima39
- Tilbaketrukket
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Bialystok, Polen, 15-027
- Tilbaketrukket
- Research Site
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Biała Podlaska, Polen, 21-500
- Tilbaketrukket
- Research Site
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Bydgoszcz, Polen, 85-796
- Tilbaketrukket
- Research Site
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Bystra, Polen, 43-360
- Rekruttering
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Lodz, Polen, 93-338
- Rekruttering
- Research Site
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Lublin, Polen, 20-090
- Har ikke rekruttert ennå
- Research Site
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Poznan, Polen, 60-569
- Rekruttering
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Warsaw, Polen, 04-141
- Rekruttering
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Wroclaw, Polen, 53-413
- Rekruttering
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San Juan, Puerto Rico, 00918
- Rekruttering
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San Juan, Puerto Rico, 00909
- Rekruttering
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Almería, Spania, 04009
- Har ikke rekruttert ennå
- Research Site
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Barcelona, Spania, 8035
- Rekruttering
- Research Site
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Las Palmas de Gran Canaria, Spania, 35016
- Rekruttering
- Research Site
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Lleida, Spania, 25198
- Rekruttering
- Research Site
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Madrid, Spania, 28007
- Rekruttering
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Madrid, Spania, 28034
- Rekruttering
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Majadahonda, Spania, 28222
- Rekruttering
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Seville, Spania, 41013
- Rekruttering
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Aberdeen, Storbritannia, AB25 2ZN
- Rekruttering
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Cambridge, Storbritannia, CB2 0QQ
- Rekruttering
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Edinburgh, Storbritannia, EH4 2XU
- Rekruttering
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Exeter, Storbritannia, EX2 5DW
- Tilbaketrukket
- Research Site
-
Greater London, Storbritannia, SW3 6JJ
- Rekruttering
- Research Site
-
London, Storbritannia, EC1A 7BE
- Rekruttering
- Research Site
-
London, Storbritannia, SE1 9RT
- Rekruttering
- Research Site
-
Manchester, Storbritannia, M20 4BX
- Rekruttering
- Research Site
-
Newcastle upon Tyne, Storbritannia, NE7 7AF
- Rekruttering
- Research Site
-
Preston, Storbritannia, PR2 9HT
- Rekruttering
- Research Site
-
-
-
-
-
Changwon-si, Sør -Korea, 51353
- Rekruttering
- Research Site
-
Cheongju-si, Sør -Korea, 28644
- Rekruttering
- Research Site
-
Incheon, Sør -Korea, 21565
- Rekruttering
- Research Site
-
JinJoo, Sør -Korea, 52727
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 03080
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 05505
- Rekruttering
- Research Site
-
Seoul, Sør -Korea, 03722
- Rekruttering
- Research Site
-
Suwon, Sør -Korea, 16247
- Rekruttering
- Research Site
-
Suwon, Sør -Korea, 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, Tyrkia (Türkiye), 6500
- Rekruttering
- Research Site
-
Antalya, Tyrkia (Türkiye), 07059
- Rekruttering
- Research Site
-
Istanbul, Tyrkia (Türkiye), 34098
- Rekruttering
- Research Site
-
Yenimahalle, Tyrkia (Türkiye), 06170
- Rekruttering
- Research Site
-
-
-
-
-
Bad Berka, Tyskland, 99437
- Rekruttering
- Research Site
-
Berlin, Tyskland, 13125
- Tilbaketrukket
- Research Site
-
Berlin, Tyskland, 13585
- Tilbaketrukket
- Research Site
-
Bielefeld, Tyskland, 33611
- Har ikke rekruttert ennå
- Research Site
-
Bochum, Tyskland, 44791
- Har ikke rekruttert ennå
- Research Site
-
Chemnitz, Tyskland, 09116
- Har ikke rekruttert ennå
- Research Site
-
Cologne, Tyskland, 51109
- Rekruttering
- Research Site
-
Cologne, Tyskland, 50677
- Har ikke rekruttert ennå
- Research Site
-
Essen, Tyskland, 45136
- Har ikke rekruttert ennå
- 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
- Har ikke rekruttert ennå
- Research Site
-
Hamburg, Tyskland, 20251
- Rekruttering
- Research Site
-
Hamburg, Tyskland, 22087
- Har ikke rekruttert ennå
- 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
- Har ikke rekruttert ennå
- 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
- Har ikke rekruttert ennå
- Research Site
-
Regensburg, Tyskland, 93053
- Rekruttering
- Research Site
-
Schwerin, Tyskland, 19049
- Har ikke rekruttert ennå
- Research Site
-
Velbert, Tyskland, 42551
- Har ikke rekruttert ennå
- 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
- Har ikke rekruttert ennå
- Research Site
-
Gyöngyös, Ungarn, 3200
- Tilbaketrukket
- Research Site
-
Gyöngyös - Mátraháza, Ungarn, 3200
- Rekruttering
- Research Site
-
Győr, Ungarn, 9024
- Rekruttering
- Research Site
-
Pécs, Ungarn, 7624
- Rekruttering
- Research Site
-
Székesfehérvár, Ungarn, 8000
- Suspendert
- 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, Østerrike, 6020
- Rekruttering
- Research Site
-
Krems, Østerrike, 3500
- Rekruttering
- Research Site
-
Rankweil, Østerrike, 6830
- Rekruttering
- Research Site
-
Vienna, Østerrike, 1210
- Rekruttering
- Research Site
-
Vienna, Østerrike, 1160
- Rekruttering
- Research Site
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 navn:
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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. november 2024
Primær fullføring (Antatt)
1. juli 2030
Studiet fullført (Antatt)
1. juli 2030
Datoer for studieregistrering
Først innsendt
4. oktober 2024
Først innsendt som oppfylte QC-kriteriene
14. november 2024
Først lagt ut (Faktiske)
18. november 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Karsinom, ikke-småcellet lunge
- Organiske kjemikalier
- Hydrokarboner
- Cycloparaffins
- Hydrokarboner, alicyklisk
- Hydrokarboner, syklisk
- Terpener
- Koordinasjonskomplekser
- Taxoider
- Cyclodecanes
- Diterpenes
- Karboplatin
- Paclitaxel
- pembrolizumab
- 130-nm albuminbundet paclitaxel
Andre studie-ID-numre
- D702BC00001
- 2024-514281-39-00 (Registeridentifikator: CTIS (EU))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Tilgangskriterier for IPD-deling
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 Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .