Fase III, åben-label, undersøgelse af First-line Dato-DXd i kombination med Rilvegostomig til avanceret ikke-pladeepitel NSCLC med høj PD-L1-ekspression (TC ≥ 50%) og uden handlingsbare genomiske ændringer (TROPION-Lung10)
27. oktober 2026 opdateret af: AstraZeneca
Et fase III, randomiseret, åbent, globalt studie af datopotamab deruxtecan (Dato-DXd) i kombination med rilvegostomig eller rilvegostomig monoterapi versus pembrolizumab monoterapi til førstelinjebehandling af deltagere med lokalt avanceret eller metastatisk ikke-LC-squam PD-L1-ekspression (TC ≥ 50%) og uden handlingsbare genomiske ændringer (TROPION-Lung10)
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy compared with Pembrolizumab monotherapy for the first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
675
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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Birtinya, Australien, 4575
- Trukket tilbage
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Blacktown, Australien, 2148
- Trukket tilbage
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Clayton, Australien, 3168
- Rekruttering
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Gosford, Australien, 2250
- Rekruttering
- Research Site
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Melbourne, Australien, 3000
- Trukket tilbage
- Research Site
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South Brisbane, Australien, QL 4101
- Rekruttering
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Wodonga, Australien, 3690
- Rekruttering
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Anderlecht, Belgien, 1070
- Trukket tilbage
- Research Site
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Bruges, Belgien, 8000
- Rekruttering
- Research Site
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Hasselt, Belgien, 3500
- Rekruttering
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La Louvière, Belgien, 7100
- Rekruttering
- Research Site
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Liège, Belgien, 4000
- Rekruttering
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Barretos, Brasilien, 14784-400
- Rekruttering
- Research Site
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Curitiba, Brasilien, 80730-150
- Rekruttering
- Research Site
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Florianópolis, Brasilien, 88034-000
- Rekruttering
- Research Site
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Ipatinga, Brasilien, 35162-189
- Rekruttering
- Research Site
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Natal, Brasilien, 59075-740
- Rekruttering
- Research Site
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Porto Alegre, Brasilien, 91350-200
- Rekruttering
- Research Site
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Rio de Janeiro, Brasilien, 22211-230
- Rekruttering
- Research Site
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Santa Maria, Brasilien, 97015-450
- Rekruttering
- Research Site
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São Paulo, Brasilien, 01221-020
- Rekruttering
- Research Site
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Taubaté, Brasilien, 12030-200
- Rekruttering
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Chicoutimi, Canada, G7H 5H6
- Rekruttering
- Research Site
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British Columbia
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Vancouver, British Columbia, Canada, VSZ 4E6
- Rekruttering
- Research Site
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Rekruttering
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Ontario
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London, Ontario, Canada, N6A 4L6
- Rekruttering
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Newmarket, Ontario, Canada, L3Y 2P9
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Oshawa, Ontario, Canada, L1G 2B9
- Rekruttering
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Toronto, Ontario, Canada, M4N 3M5
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- Research Site
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Quebec
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Lévis, Quebec, Canada, G6V 0B8
- Rekruttering
- Research Site
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Montreal, Quebec, Canada, H4J 1C5
- Rekruttering
- Research Site
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Montreal, Quebec, Canada, H3T 1E2
- Rekruttering
- Research Site
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Montreal, Quebec, Canada, H3T 1M5
- Trukket tilbage
- Research Site
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Rimouski, Quebec, Canada, G5L 5T1
- Rekruttering
- Research Site
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Trois-Rivières, Quebec, Canada, G8Z 3R9
- Rekruttering
- Research Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 4H4
- Rekruttering
- Research Site
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Cheltenham, Det Forenede Kongerige, GL53 7AN
- Suspenderet
- Research Site
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Inverness, Det Forenede Kongerige, IV2 3UJ
- Suspenderet
- Research Site
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London, Det Forenede Kongerige, SW17 0QT
- Rekruttering
- Research Site
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London, Det Forenede Kongerige, SW10 9NH
- Rekruttering
- Research Site
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London, Det Forenede Kongerige, SE1 9RT
- Trukket tilbage
- Research Site
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Norwich, Det Forenede Kongerige, NR4 7UY
- Rekruttering
- Research Site
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Preston, Det Forenede Kongerige, PR2 9HT
- Rekruttering
- Research Site
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Truro, Det Forenede Kongerige, TR1 3LJ
- Rekruttering
- Research Site
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Rekruttering
- Research Site
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Arizona
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Tucson, Arizona, Forenede Stater, 85719
- Rekruttering
- Research Site
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- Rekruttering
- Research Site
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Springdale, Arkansas, Forenede Stater, 72762
- Rekruttering
- Research Site
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California
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Anaheim, California, Forenede Stater, 92801
- Rekruttering
- Research Site
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Beverly Hills, California, Forenede Stater, 90211
- Rekruttering
- Research Site
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Fountain Valley, California, Forenede Stater, 92708
- Rekruttering
- Research Site
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Newport Beach, California, Forenede Stater, 92663
- Suspenderet
- Research Site
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Florida
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Clermont, Florida, Forenede Stater, 34711
- Rekruttering
- Research Site
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Gainesville, Florida, Forenede Stater, 32608
- Rekruttering
- Research Site
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Miami Beach, Florida, Forenede Stater, 33140
- Rekruttering
- Research Site
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Orange City, Florida, Forenede Stater, 32763
- Rekruttering
- Research Site
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Orlando, Florida, Forenede Stater, 32806
- Rekruttering
- Research Site
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Orlando, Florida, Forenede Stater, 32827
- Trukket tilbage
- Research Site
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West Palm Beach, Florida, Forenede Stater, 33401
- Rekruttering
- Research Site
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Research Site
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Atlanta, Georgia, Forenede Stater, 30318
- Rekruttering
- Research Site
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Atlanta, Georgia, Forenede Stater, 30342
- Trukket tilbage
- Research Site
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Atlanta, Georgia, Forenede Stater, 30303
- Suspenderet
- Research Site
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Illinois
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Hinsdale, Illinois, Forenede Stater, 60521
- Rekruttering
- Research Site
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Indiana
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Noblesville, Indiana, Forenede Stater, 46062
- Rekruttering
- Research Site
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Kentucky
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Paducah, Kentucky, Forenede Stater, 42003
- Rekruttering
- Research Site
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
- Rekruttering
- Research Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Research Site
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Research Site
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Michigan
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Dearborn, Michigan, Forenede Stater, 48126
- Rekruttering
- Research Site
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Farmington Hills, Michigan, Forenede Stater, 48334
- Rekruttering
- Research Site
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Grand Rapids, Michigan, Forenede Stater, 49503
- Rekruttering
- Research Site
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Traverse City, Michigan, Forenede Stater, 49684
- Trukket tilbage
- Research Site
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
- Rekruttering
- Research Site
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Missouri
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Kansas City, Missouri, Forenede Stater, 64132
- Rekruttering
- Research Site
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Montana
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Bozeman, Montana, Forenede Stater, 59715
- Trukket tilbage
- Research Site
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Nebraska
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Grand Island, Nebraska, Forenede Stater, 68803
- Rekruttering
- Research Site
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Omaha, Nebraska, Forenede Stater, 68130
- Rekruttering
- Research Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- Rekruttering
- Research Site
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Reno, Nevada, Forenede Stater, 89502
- Trukket tilbage
- Research Site
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New Jersey
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Voorhees Township, New Jersey, Forenede Stater, 08043
- Suspenderet
- Research Site
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New York
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Stony Brook, New York, Forenede Stater, 11794
- Rekruttering
- Research Site
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North Carolina
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Greenville, North Carolina, Forenede Stater, 27834
- Rekruttering
- Research Site
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Salisbury, North Carolina, Forenede Stater, 28144
- Rekruttering
- Research Site
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- Research Site
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Columbus, Ohio, Forenede Stater, 43210
- Trukket tilbage
- Research Site
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Maumee, Ohio, Forenede Stater, 43537
- Rekruttering
- Research Site
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Toledo, Ohio, Forenede Stater, 43623
- Rekruttering
- Research Site
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- Trukket tilbage
- Research Site
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South Carolina
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Greenville, South Carolina, Forenede Stater, 29607
- Rekruttering
- Research Site
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Rekruttering
- Research Site
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
- Trukket tilbage
- Research Site
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Knoxville, Tennessee, Forenede Stater, 37920
- Trukket tilbage
- Research Site
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Texas
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Fort Worth, Texas, Forenede Stater, 76104
- Rekruttering
- Research Site
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Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Research Site
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Houston, Texas, Forenede Stater, 77030
- Trukket tilbage
- Research Site
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Houston, Texas, Forenede Stater, 77090
- Suspenderet
- Research Site
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Kingwood, Texas, Forenede Stater, 77339
- Rekruttering
- Research Site
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Odessa, Texas, Forenede Stater, 79761
- Rekruttering
- Research Site
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Virginia
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Fort Belvoir, Virginia, Forenede Stater, 22060
- Rekruttering
- Research Site
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Leesburg, Virginia, Forenede Stater, 20176
- Rekruttering
- Research Site
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Midlothian, Virginia, Forenede Stater, 23114
- Rekruttering
- Research Site
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Richmond, Virginia, Forenede Stater, 23230
- Rekruttering
- Research Site
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Washington
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Tacoma, Washington, Forenede Stater, 98405
- Rekruttering
- Research Site
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Vancouver, Washington, Forenede Stater, 98684
- Rekruttering
- Research Site
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Wenatchee, Washington, Forenede Stater, 98801
- Rekruttering
- Research Site
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Wisconsin
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Appleton, Wisconsin, Forenede Stater, 54911
- Rekruttering
- Research Site
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-
-
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Chennai, Indien, 600031
- Rekruttering
- Research Site
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Dwārka, Indien, 110075
- Rekruttering
- Research Site
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Jaipur, Indien, 302004
- Rekruttering
- Research Site
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Kolkata, Indien, 700099
- Rekruttering
- Research Site
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Marg Jaipur, Indien, 302004
- Trukket tilbage
- Research Site
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Nagpur, Indien, 440001
- Rekruttering
- Research Site
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Nashik, Indien, 422011
- Rekruttering
- Research Site
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New Delhi, Indien, 11029
- Rekruttering
- Research Site
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New Delhi, Indien, 110085
- Rekruttering
- Research Site
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Surat, Indien, 395002
- Rekruttering
- Research Site
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Thiruvananthapuram, Indien, 695011
- Trukket tilbage
- Research Site
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Bergamo, Italien, 24125
- Rekruttering
- Research Site
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Genoa, Italien, 16132
- Rekruttering
- Research Site
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Milan, Italien, 20141
- Rekruttering
- Research Site
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Milan, Italien, 20162
- Rekruttering
- Research Site
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Monza, Italien, 20052
- Rekruttering
- Research Site
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Padova, Italien, 35128
- Rekruttering
- Research Site
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Pavia, Italien, 27100
- Rekruttering
- Research Site
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Ravenna, Italien, 48100
- Rekruttering
- Research Site
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Roma, Italien, 00128
- Rekruttering
- Research Site
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Rozzano, Italien, 20089
- Rekruttering
- Research Site
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Bunkyō City, Japan, 113-8431
- Rekruttering
- Research Site
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Bunkyō City, Japan, 160-0023
- Rekruttering
- Research Site
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Fukuoka, Japan, 812-8582
- Rekruttering
- Research Site
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Fukuoka, Japan, 814-0180
- Rekruttering
- Research Site
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Hakodate-shi, Japan, 040-8611
- Rekruttering
- Research Site
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Hidaka-shi, Japan, 350-1298
- Rekruttering
- Research Site
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Hirakata-shi, Japan, 573-1191
- Rekruttering
- Research Site
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Hirosaki-shi, Japan, 036-8563
- Rekruttering
- Research Site
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Hiroshima, Japan, 730-8518
- Rekruttering
- Research Site
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Kanazawa, Japan, 920-8641
- Rekruttering
- Research Site
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Kashiwa, Japan, 227-8577
- Rekruttering
- Research Site
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Kawasaki-shi, Japan, 216-8511
- Rekruttering
- Research Site
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Kumamoto, Japan, 860-8556
- Rekruttering
- Research Site
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Matsusaka-shi, Japan, 515-8544
- Rekruttering
- Research Site
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Matsuyama, Japan, 790-0024
- Rekruttering
- Research Site
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Nagoya, Japan, 460-0001
- Rekruttering
- Research Site
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Niigata, Japan, 951-8566
- Rekruttering
- Research Site
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Okayama, Japan, 700-8558
- Rekruttering
- Research Site
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Osaka, Japan, 545-8586
- Trukket tilbage
- Research Site
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Osakasayama-shi, Japan, 589-8511
- Rekruttering
- Research Site
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Sagamihara-shi, Japan, 252-0375
- Rekruttering
- Research Site
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Sapporo, Japan, 003-0804
- Rekruttering
- Research Site
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Takaoka-shi, Japan, 933-8555
- Rekruttering
- Research Site
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Takatsuki-shi, Japan, 569-8686
- Rekruttering
- Research Site
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Tokushima, Japan, 770-8503
- Rekruttering
- Research Site
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Tokyo, Japan, 104-0045
- Rekruttering
- Research Site
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Utsunomiya, Japan, 320-0834
- Rekruttering
- Research Site
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Yokohama, Japan, 221-0855
- Rekruttering
- Research Site
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-
-
-
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Beijing, Kina, 100142
- Rekruttering
- Research Site
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Beijing, Kina, 101149
- Rekruttering
- Research Site
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Changchun, Kina, 130000
- Rekruttering
- Research Site
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Changsha, Kina, 410013
- Rekruttering
- Research Site
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Chengdu, Kina, 610000
- Rekruttering
- Research Site
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Chengdu, Kina, 610041
- Rekruttering
- Research Site
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Chongqing, Kina, 400030
- Rekruttering
- Research Site
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Fuzhou, Kina, 350014
- Rekruttering
- Research Site
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Guangzhou, Kina, 510080
- Rekruttering
- Research Site
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Hangzhou, Kina, 310006
- Rekruttering
- Research Site
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Hangzhou, Kina, 310022
- Rekruttering
- Research Site
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Hangzhou, Kina, 310016
- Rekruttering
- Research Site
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Harbin, Kina, 150049
- Rekruttering
- Research Site
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Hefei, Kina, 230601
- Rekruttering
- Research Site
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Hefei, Kina, 230031
- Trukket tilbage
- Research Site
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Jinan, Kina, 250117
- Rekruttering
- Research Site
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Jining, Kina, 272011
- Trukket tilbage
- Research Site
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Kunming, Kina, 650118
- Rekruttering
- Research Site
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Lanzhou, Kina, 730000
- Rekruttering
- Research Site
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Linhai, Kina, 317000
- Rekruttering
- Research Site
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Linyi, Kina, 276001
- Rekruttering
- Research Site
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Nanjing, Kina, 210009
- Rekruttering
- Research Site
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Nanning, Kina, 530021
- Rekruttering
- Research Site
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Nanning, Kina, 530000
- Rekruttering
- Research Site
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Shanghai, Kina, 200032
- Rekruttering
- Research Site
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Shanghai, Kina, 200030
- Rekruttering
- Research Site
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Shanghai, Kina, 200433
- Rekruttering
- Research Site
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Shenyang, Kina, 110022
- Rekruttering
- Research Site
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Taiyuan, Kina, 030000
- Rekruttering
- Research Site
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Tianjin, Kina, 300060
- Rekruttering
- Research Site
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Wenzhou, Kina, 325000
- Rekruttering
- Research Site
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Wuhan, Kina, 430022
- Rekruttering
- Research Site
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Wuhan, Kina, 430030
- Rekruttering
- Research Site
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Wuhan, Kina, 430010
- Rekruttering
- Research Site
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Wuhan, Kina, 430000
- Rekruttering
- Research Site
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Xi'an, Kina, 710061
- Rekruttering
- Research Site
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Yangzhou, Kina, 225001
- Rekruttering
- Research Site
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Zhengzhou, Kina, 450000
- Rekruttering
- Research Site
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Zhengzhou, Kina, 450008
- Rekruttering
- Research Site
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-
-
-
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Olsztyn, Polen, 10-357
- Rekruttering
- Research Site
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Poznan, Polen, 60-569
- Rekruttering
- Research Site
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Przemyśl, Polen, 37-700
- Rekruttering
- Research Site
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Warsaw, Polen, 02-781
- Rekruttering
- Research Site
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Warsaw, Polen, 01-138
- Rekruttering
- Research Site
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-
-
-
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San Juan, Puerto Rico, 00909
- Rekruttering
- Research Site
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-
-
-
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Alicante, Spanien, 03010
- Rekruttering
- Research Site
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Barcelona, Spanien, 08036
- Rekruttering
- Research Site
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Barcelona, Spanien, 08003
- Rekruttering
- Research Site
-
Barcelona, Spanien, 08041
- Ikke rekrutterer endnu
- Research Site
-
Jerez de la Frontera, Spanien, 11407
- Rekruttering
- Research Site
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Reus, Spanien, 43204
- Rekruttering
- Research Site
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Salamanca, Spanien, 37007
- Trukket tilbage
- Research Site
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-
-
-
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Changwon, Sydkorea, 51353
- Rekruttering
- Research Site
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Incheon, Sydkorea, 21565
- Rekruttering
- Research Site
-
Seongnam-si, Sydkorea, 13496
- Rekruttering
- Research Site
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Seoul, Sydkorea, 03080
- Rekruttering
- Research Site
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Seoul, Sydkorea, 03722
- Rekruttering
- Research Site
-
Seoul, Sydkorea, 08308
- Ikke rekrutterer endnu
- Research Site
-
Seoul, Sydkorea, 06973
- Rekruttering
- Research Site
-
Suwon, Sydkorea, 16247
- Rekruttering
- Research Site
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Suwon, Sydkorea, 16499
- Rekruttering
- Research Site
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-
-
-
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Changhua, Taiwan, 500
- Ikke rekrutterer endnu
- Research Site
-
Kaohsiung City, Taiwan, 80756
- Rekruttering
- Research Site
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New Taipei City, Taiwan, 220
- Rekruttering
- Research Site
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Taichung, Taiwan, 40447
- Rekruttering
- Research Site
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Taichung, Taiwan, 40705
- Rekruttering
- Research Site
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Tainan, Taiwan, 704
- Rekruttering
- Research Site
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Taipei, Taiwan, TAIWAN
- Rekruttering
- Research Site
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Taipei, Taiwan, 10002
- Rekruttering
- Research Site
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Taipei, Taiwan, 112
- Rekruttering
- Research Site
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Taipei, Taiwan, 0116
- Rekruttering
- Research Site
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Taoyuan, Taiwan, 333
- Rekruttering
- Research Site
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-
-
-
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Bangkok, Thailand, 10400
- Rekruttering
- Research Site
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Bangkok, Thailand, 10700
- Rekruttering
- Research Site
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Hat Yai, Thailand, 90110
- Rekruttering
- Research Site
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Muang, Thailand, 22000
- Rekruttering
- Research Site
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Mueang, Thailand, 20000
- Rekruttering
- Research Site
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Mueang, Thailand, 32000
- Rekruttering
- Research Site
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-
-
-
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Adapazarı, Tyrkiet (Türkiye), 54100
- Rekruttering
- Research Site
-
Ankara, Tyrkiet (Türkiye), 6200
- Rekruttering
- Research Site
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Ankara, Tyrkiet (Türkiye), 06560
- Rekruttering
- Research Site
-
Antalya, Tyrkiet (Türkiye), 07070
- Rekruttering
- Research Site
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Diyarbakır, Tyrkiet (Türkiye), 21280
- Rekruttering
- Research Site
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Istanbul, Tyrkiet (Türkiye), 34030
- Rekruttering
- Research Site
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Istanbul, Tyrkiet (Türkiye), 34890
- Rekruttering
- Research Site
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-
-
-
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Berlin, Tyskland, 10249
- Ikke rekrutterer endnu
- Research Site
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Bonn, Tyskland, 53113
- Rekruttering
- Research Site
-
Cologne, Tyskland, 50677
- Rekruttering
- Research Site
-
Düsseldorf, Tyskland, 40489
- Trukket tilbage
- Research Site
-
Essen, Tyskland, 45136
- Rekruttering
- Research Site
-
Freiburg im Breisgau, Tyskland, 79106
- Rekruttering
- Research Site
-
Gauting, Tyskland, 82131
- Rekruttering
- Research Site
-
Georgsmarienhütte, Tyskland, 49124
- Trukket tilbage
- Research Site
-
Gera, Tyskland, 07548
- Trukket tilbage
- Research Site
-
Gütersloh, Tyskland, 33332
- Trukket tilbage
- Research Site
-
Hamburg, Tyskland, 20251
- Rekruttering
- Research Site
-
Hamburg, Tyskland, 22087
- Rekruttering
- Research Site
-
Heidelberg, Tyskland, 69126
- Rekruttering
- Research Site
-
Kempten, Tyskland, 87439
- Suspenderet
- Research Site
-
Kiel, Tyskland, 24116
- Ikke rekrutterer endnu
- Research Site
-
Koblenz, Tyskland, 56068
- Suspenderet
- Research Site
-
Ludwigsburg, Tyskland, 71640
- Trukket tilbage
- Research Site
-
München, Tyskland, 81925
- Rekruttering
- Research Site
-
Nuremberg, Tyskland, 90419
- Trukket tilbage
- Research Site
-
Potsdam, Tyskland, 14467
- Rekruttering
- Research Site
-
Ravensburg, Tyskland, 88212
- Rekruttering
- Research Site
-
-
-
-
-
Budapest, Ungarn, 1121
- Rekruttering
- Research Site
-
Edelény, Ungarn, 3780
- Ikke rekrutterer endnu
- Research Site
-
Gyula, Ungarn, 5700
- Suspenderet
- Research Site
-
Gyöngyös, Ungarn, 3200
- Trukket tilbage
- Research Site
-
Gyöngyös - Mátraháza, Ungarn, 3200
- Rekruttering
- Research Site
-
Győr, Ungarn, 9024
- Rekruttering
- Research Site
-
Kecskemét, Ungarn, 6000
- Rekruttering
- Research Site
-
Salgótarján, Ungarn, 3100
- Trukket tilbage
- Research Site
-
Szekszárd, Ungarn, 7100
- Rekruttering
- Research Site
-
Szolnok, Ungarn, 5000
- Trukket tilbage
- Research Site
-
Székesfehérvár, Ungarn, 8000
- Trukket tilbage
- Research Site
-
Törökbálint, Ungarn, 2045
- Rekruttering
- Research Site
-
-
-
-
-
Da Nang, Vietnam, 550000
- Rekruttering
- Research Site
-
Hanoi, Vietnam, 100000
- Rekruttering
- Research Site
-
Ho Chi Minh City, Vietnam, 700000
- Rekruttering
- Research Site
-
Ho Chi Minh City, Vietnam, 700000
- Trukket tilbage
- Research Site
-
Huế, Vietnam, 530000
- Trukket tilbage
- Research Site
-
Hà Nội, Vietnam, 100000
- Rekruttering
- Research Site
-
Vinh, Vietnam, 460000
- Trukket tilbage
- Research Site
-
Vĩnh Yên, Vietnam, 280000
- Rekruttering
- Research Site
-
-
-
-
-
Innsbruck, Østrig, 6020
- Rekruttering
- Research Site
-
Krems, Østrig, 3500
- Rekruttering
- Research Site
-
Linz, Østrig, 4020
- Rekruttering
- Research Site
-
Rankweil, Østrig, 6830
- Rekruttering
- Research Site
-
Vienna, Østrig, 1210
- Rekruttering
- Research Site
-
Vienna, Østrig, 1140
- Rekruttering
- Research Site
-
Wels, Østrig, 4600
- Trukket tilbage
- 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 non-squamous NSCLC.
- Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
- Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
- Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
- Known tumour PD-L1 expression status defined as TC ≥ 50%
- At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
- ECOG performance status of 0 or 1
- Adequate bone marrow reserve and organ function
Exclusion Criteria:
- Prior systemic therapy for advanced/metastatic NSCLC.
- Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
- History of another primary malignancy within 3 years
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol.
- Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
- History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Has significant pulmonary function compromise, as determined by the investigator
- Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
- History of leptomeningeal carcinomatosis
- Known clinically significant corneal disease
- Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
- History of active primary immunodeficiency
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: Enkelt
Antal våben
3
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig
Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
Datopotamab Deruxtecan IV (intravenous)
Andre navne:
Rilvegostomig IV (intravenous)
Andre navne:
|
|
Eksperimentel: Arm 2: Rilvegostomig Monotherapy
Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
Rilvegostomig IV (intravenous)
Andre navne:
|
|
Aktiv komparator: Arm 3: Pembrolizumab Monotherapy
Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
Pembrolizumab IV (intravenous)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) in TROP2 biomarker positive participants.
Tidsramme: Approximately 4 years
|
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis. |
Approximately 4 years
|
|
Overall Survival (OS) in TROP2 biomarker positive participants.
Tidsramme: Approximately 6 years
|
OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of OS. |
Approximately 6 years
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) in the FAS population.
Tidsramme: Approximately 4 years
|
PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • FAS population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis. |
Approximately 4 years
|
|
Overall Survival (OS) in the FAS population.
Tidsramme: Approximately 6 years
|
OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population: • FAS population The measure of interest is the HR of OS. |
Approximately 6 years
|
|
Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations
Tidsramme: Approximately 4 years
|
ORR is defined as the proportion of participants who have a CR or PR, as determined by BICR per RECIST 1.1. The analyses will include all randomised participants, as randomised, with measurable disease at baseline, in the following populations:
The measure of interest is the difference of the ORR. ORR by investigator will be reported as a sensitivity analysis. |
Approximately 4 years
|
|
Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations
Tidsramme: Approximately 4 years
|
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR or death due to any cause. The analyses will include all randomised participants who have a response, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following populations:
|
Approximately 4 years
|
|
Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab.
Tidsramme: Approximately 6 years
|
Time to deterioration in: pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ, in overall lung cancer symptoms as measured by the NSCLC-SAQ, and in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172. Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations:
|
Approximately 6 years
|
|
Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab.
Tidsramme: Approximately 6 years
|
Time to deterioration in physical functioning as measured by PROMIS Physical Function short form 8c. Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations:
|
Approximately 6 years
|
|
Pharmacokinetics (PK)
Tidsramme: Approximately 6 years
|
Concentration of rilvegostomig, Dato-DXd, total anti TROP2 antibody, and MAAA 1181a (payload deruxtecan) in plasma or serum and PK parameters (peak and trough concentrations). |
Approximately 6 years
|
|
Immunogenicity
Tidsramme: Approximately 6 years
|
Presence of ADA for Dato-DXd and rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples). |
Approximately 6 years
|
|
Second Progression-Free Survival (PFS2).
Tidsramme: Approximately 6 years
|
PFS2 is defined as the time from randomisation to the earliest of the progression events (following the initial progression), subsequent to first subsequent therapy, or death. Progression event includes radiological (RECIST 1.1) or clinical disease progression. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard practice. The analyses will include all randomised participants, as randomised, regardless of whether the participant withdraws from subsequent therapy and regardless of missed visits, in the following populations:
|
Approximately 6 years
|
Andre resultatmål
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety of Dato-DXd in combination with rilvegostomig and rilvegostomig monotherapy as compared with pembrolizumab.
Tidsramme: Approximately 6 years
|
Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE Version 5.0). |
Approximately 6 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Efterforskere
Efterforskere
- Ledende efterforsker: Suresh S. Ramalingam, MD, Emory University, Atlanta, Georgia, United States of America.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
11. april 2024
Primær færdiggørelse (Anslået)
Primær færdiggørelse
28. december 2029
Studieafslutning (Anslået)
Studieafslutning
28. december 2029
Datoer for studieregistrering
Først indsendt
Først indsendt
5. april 2024
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
5. april 2024
Først opslået (Faktiske)
Først opslået
10. april 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
28. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. oktober 2026
Sidst verificeret
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- D7632C00001
- 2023-505077-32-00 (Registry Identifier: CTIS (EU))
- 2023 (U.S. NIH-bevilling/kontrakt)
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 group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
For details of our timelines, please rerefer 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 deidentified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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 .