En global undersøgelse for at vurdere virkningerne af Durvalumab + Domvanalimab efter samtidig kemoradiation hos deltagere med trin III uoperabel NSCLC (PACIFIC-8)
26. august 2026 opdateret af: AstraZeneca
Et fase III, randomiseret, dobbeltblindt, placebokontrolleret, multicenter, internationalt studie af Durvalumab Plus Domvanalimab(AB154) hos deltagere med lokalt avanceret (stadie III), uoperabel ikke-småcellet lungekræft, hvis sygdom ikke er udviklet efter endelig platin -baseret Concurrent Chemoradiation Therapy
Dette er et fase III, randomiseret, dobbeltblindt, placebokontrolleret, multicenter, internationalt studie, der vurderer effektiviteten og sikkerheden af durvalumab (MEDI4736) og domvanalimab (AB154) sammenlignet med durvalumab plus placebo hos voksne med lokalt fremskreden (stadie III), uoperabel NSCLC, hvis sygdom ikke er udviklet efter definitiv platinbaseret cCRT.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
791
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brussels, Belgien, 1160
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Edegem, Belgien, 2650
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Haine-Saint-Paul, Belgien, 7100
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Leuven, Belgien, 3000
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Liège, Belgien, 4000
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Sint-Niklaas, Belgien, 9100
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Barretos, Brasilien, 14784-400
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Londrina, Brasilien, 86015-520
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Porto Alegre, Brasilien, 91350200
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Porto Velho, Brasilien, 76834-899
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Rio de Janeiro, Brasilien, 20231-050
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Santo André, Brasilien, 09060-650
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São Paulo, Brasilien, 01221-900
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Taubaté, Brasilien, 12030-200
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Alberta
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Calgary, Alberta, Canada, T2N 5G2
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
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Quebec
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Laval, Quebec, Canada, H7M 3L9
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Montreal, Quebec, Canada, H4A 3J1
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Las Condes, Chile, 7560908
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Port Montt, Chile, 5500243
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Santiago, Chile, 7500713
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Santiago, Chile, 7630370
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Santiago, Chile, 8241479
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Santiago, Chile, 7520426
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Temuco, Chile, 4810218
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Birmingham, Det Forenede Kongerige, B9 5SS
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Brighton, Det Forenede Kongerige, BN2 5BE
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Cardiff, Det Forenede Kongerige, CF14 2TL
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Cheltenham, Det Forenede Kongerige, GL53 7AN
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Edinburgh, Det Forenede Kongerige, EH4 2XR
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High Heaton/Newcastle Upon Tyn, Det Forenede Kongerige, NE7 7DN
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Leeds, Det Forenede Kongerige, LS 9 7TF
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London, Det Forenede Kongerige, SE1 9RT
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Nottingham, Det Forenede Kongerige, NG5 1PB
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Truro, Det Forenede Kongerige, TR1 3LJ
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City of Muntinlupa, Filippinerne, 1780
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Iloilo City, Filippinerne, 5000
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Quezon City, Filippinerne, 1112
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Quezon City, Filippinerne, 1100
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
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Phoenix, Arizona, Forenede Stater, 85054
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California
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Fountain Valley, California, Forenede Stater, 92708
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Santa Rosa, California, Forenede Stater, 95403
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20016
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
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Orlando, Florida, Forenede Stater, 32804
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Saint Augustine, Florida, Forenede Stater, 32086
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Georgia
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Macon, Georgia, Forenede Stater, 31217
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Illinois
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Elmhurst, Illinois, Forenede Stater, 60126
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40202
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
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Silver Spring, Maryland, Forenede Stater, 20910
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106-0995
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Detroit, Michigan, Forenede Stater, 48202
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Minneapolis, Minnesota, Forenede Stater, 55407
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Rochester, Minnesota, Forenede Stater, 55905
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Nevada
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Reno, Nevada, Forenede Stater, 89511
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New Jersey
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East Brunswick, New Jersey, Forenede Stater, 08816
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Ohio
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Columbus, Ohio, Forenede Stater, 43214
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Maumee, Ohio, Forenede Stater, 43537
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73102
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29401
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37404
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Nashville, Tennessee, Forenede Stater, 37203
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Nashville, Tennessee, Forenede Stater, 37232
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Texas
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Fort Sam Houston, Texas, Forenede Stater, 78234
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
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Fort Belvoir, Virginia, Forenede Stater, 22060
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Washington
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Spokane Valley, Washington, Forenede Stater, 99216
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Wisconsin
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Appleton, Wisconsin, Forenede Stater, 54911
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Aix-en-Provence, Frankrig, 13616
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Angers, Frankrig, 49055
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Bobigny, Frankrig, 93000
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Lille, Frankrig, 59000
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Paris, Frankrig, 75014
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Pau, Frankrig, 6400
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Quimper, Frankrig, 29000
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Saint-Grégoire, Frankrig, 35760
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Saint-Quentin, Frankrig, 02321
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Vantoux, Frankrig, 57070
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Villeurbanne, Frankrig, 69100
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Athens, Grækenland, 11527
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Athens, Grækenland, 18547
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Athens, Grækenland, 12462
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Athens, Grækenland, 11526
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Holargos, Athens, Grækenland, 155 62
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Thessaloniki, Grækenland, 56 429
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Thessaloniki, Grækenland, 57001
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Thessaloniki, Grækenland, 55236
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Hong Kong, Hong Kong, 150001
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Ahmedabad, Indien, 380054
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Bangalore, Indien, 560027
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Bangalore, Indien, 560064
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Delhi, Indien, 110085
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Howrah, Indien, 711103
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Hyderabad, Indien, 500032
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Jaipur, Indien, 302004
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Jaipur, Indien, 302022
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Kolkata, Indien, 700160
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Marg Jaipur, Indien, 302004
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Mohali, Indien, 160055
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Namakkal, Indien, 637001
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New Delhi, Indien, 110029
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New Delhi, Indien, 110005
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Varanasi, Indien, 221005
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Bergamo, Italien, 24127
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Roma, Italien, 00144
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Rozzano, Italien, 20089
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Bunkyō City, Japan, 113-8431
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Bunkyō City, Japan, 113-8603
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Bunkyō City, Japan, 113-8677
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Chiba, Japan, 260-8717
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Fukuoka, Japan, 812-8582
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Hidaka-shi, Japan, 350-1298
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Hirosaki-shi, Japan, 036-8563
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Itabashi-ku, Japan, 173-0003
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Kashihara-shi, Japan, 634-8522
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Kumamoto, Japan, 860-8556
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Kōtoku, Japan, 135-8550
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Matsuyama, Japan, 791-0280
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Nagoya, Japan, 464-8681
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Osaka, Japan, 545-8586
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Osakasayama-shi, Japan, 589-8511
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Sapporo, Japan, 003-0804
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Sunto-gun, Japan, 411-8777
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Tokyo, Japan, 104-0045
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Yokohama, Japan, 241-8515
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Yokohama, Japan, 221-0855
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Johor Bahru, Malaysia, 81100
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Kuala Lumpur, Malaysia, 59100
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Kuala Selangor, Malaysia, 46050
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Kuching, Malaysia, 93586
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Chihuahua City, Mexico, 31207
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Guadalajara, Mexico, 44638
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Mexico City, Mexico, 03810
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Oaxaca City, Mexico, 68020
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Bodø, Norge, 8092
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Gjøvik, Norge, 2819
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Oslo, Norge, 0379
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Trondheim, Norge, 0730
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Bialystok, Polen, 15-027
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Gliwice, Polen, 44-102
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Katowice, Polen, 40-074
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Lodz, Polen, 93-513
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Warsaw, Polen, 02-781
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Wroclaw, Polen, 53-413
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Bucharest, Rumænien, 050098
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Bucharest, Rumænien, 022328
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Craiova, Rumænien, 200542
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Floreşti, Rumænien
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Iași, Rumænien, 700483
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Oradea, Rumænien, 410001
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Sibiu, Rumænien, 550245
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Suceava, Rumænien, 720214
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Basel, Schweiz, 4031
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Bern, Schweiz, CH-3010
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Lausanne, Schweiz, 1011
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Bilbao (Vizcaya), Spanien, 48013
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Castellon, Spanien, 12002
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Córdoba, Spanien, 14004
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El Palmar, Spanien, 30120
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Palma de Mallorca, Spanien, 07010
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Sabadell (Barcelona), Spanien, 08208
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Parktown, Sydafrika, 2193
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Pretoria, Sydafrika, 0084
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eManzimtoti, Sydafrika, 4126
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Daegu, Sydkorea, 42415
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Goyang-si, Sydkorea, 10408
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Incheon, Sydkorea, 21565
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Incheon, Sydkorea, 21431
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Jinju, Sydkorea, 52727
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Seoul, Sydkorea, 03722
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Seoul, Sydkorea, 06273
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Seoul, Sydkorea, 06351
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Seoul, Sydkorea, 07061
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Suwon, Sydkorea, 16247
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Hsinchu, Taiwan, 300
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New Taipei City, Taiwan, 220216
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 40447
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Tainan, Taiwan, 704
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 10449
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Taipei, Taiwan, 11217
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Taoyuan, Taiwan, 333
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Bangkok, Thailand, 10300
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Bangkok, Thailand, 10400
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Bangkok, Thailand, 10700
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Hat Yai, Thailand, 90110
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Adapazarı, Tyrkiet (Türkiye), 54290
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Ankara, Tyrkiet (Türkiye), 06340
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Ankara, Tyrkiet (Türkiye), 6100
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Antalya, Tyrkiet (Türkiye), 07058
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Edirne, Tyrkiet (Türkiye), 22030
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Istanbul, Tyrkiet (Türkiye), 34098
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Istanbul, Tyrkiet (Türkiye), 34662
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Izmir, Tyrkiet (Türkiye), 35360
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Konya, Tyrkiet (Türkiye), 42080
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Çankaya, Tyrkiet (Türkiye), 06680
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Berlin, Tyskland, 12351
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Berlin-Zehlendorf, Tyskland, 14165
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Braunschweig, Tyskland, 38114
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Chemnitz, Tyskland, 09116
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Cologne, Tyskland, 51109
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Erlangen, Tyskland, 91054
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Essen, Tyskland, 45147
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Giessen, Tyskland, 35392
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Halle, Tyskland, 06120
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Koblenz, Tyskland, 56073
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Krefeld, Tyskland, 47805
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Löwenstein, Tyskland, 74245
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Moers, Tyskland, 47441
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Regensburg, Tyskland, 93053
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Regensburg, Tyskland, 93049
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Tübingen, Tyskland, 72076
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Budapest, Ungarn, 1121
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Budapest, Ungarn, 1122
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Deszk, Ungarn, 6772
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Győr, Ungarn, 9024
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Salgótarján, Ungarn, 3100
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Székesfehérvár, Ungarn, 8000
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Törökbálint, Ungarn, 2045
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Hanoi, Vietnam, 100000
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Hanoi, Vietnam, 10000
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Ho Chi Minh City, Vietnam, 700000
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
INKLUSIONSKRITERIER:
- Deltageren skal være ≥ 18 år på screeningstidspunktet.
- Histologisk eller cytologisk dokumenteret NSCLC og er blevet behandlet med samtidig CRT for lokalt fremskreden, inoperabel (stadie III) sygdom 3. Tilvejebringelse af en tumorvævsprøve opnået før CRT
- Tilvejebringelse af en tumorvævsprøve opnået før CRT
- Dokumenteret tumor PD-L1 status ≥ 1 % af centralt laboratorium
- Dokumenteret EGFR og ALK vildtype status (lokal eller central).
- Patienter må ikke have udviklet sig efter definitiv, platinbaseret, samtidig kemoradioterapi
- Deltagerne skal have modtaget mindst 2 cyklusser af platinbaseret kemoterapi samtidig med strålebehandling
- Deltagerne skal have modtaget en samlet strålingsdosis på 60 Gy ±10 % (54 Gy til 66 Gy) som en del af kemoradiationsterapien for at blive randomiseret. Strålebehandling bør administreres ved intensitetsmoduleret RT (foretrukken) eller 3D-konform teknik.
- WHO præstationsstatus på 0 eller 1 ved randomisering
- Tilstrækkelig organ- og marvfunktion
EXKLUSIONSKRITERIER:
- Anamnese med en anden primær malignitet bortset fra malignitet behandlet med kurativ hensigt uden kendt aktiv sygdom > 5 år før den første dosis af undersøgelsesintervention og med lav potentiel risiko for recidiv, basalcellekarcinom i huden, pladecellekarcinom i huden eller lentigo maligne, der har gennemgået potentielt helbredende behandling, tilstrækkeligt behandlet carcinoma in situ eller Ta-tumorer behandlet med helbredende hensigt og uden tegn på sygdom.
- Blandet småcellet og ikke-småcellet lungecancer histologi.
- Deltagere, der modtager sekventiel (ikke inklusiv induktion) kemoradiationsterapi for lokalt fremskreden (stadie III) ikke-operabel NSCLC.
- Deltagere med lokalt fremskreden (stadium III) ikke-operabel NSCLC, som har udviklet sig under platinbaseret cCRT.
- Enhver uafklaret toksicitet CTCAE >grad 2 fra den tidligere kemoradiationsbehandling (eksklusive alopeci).
- Deltagere med ≥grad 2 pneumonitis fra tidligere kemoradiationsbehandling.
- Anamnese med idiopatisk lungefibrose, organiserende lungebetændelse, lægemiddelinduceret lungebetændelse eller idiopatisk lungebetændelse, eller tegn på aktiv pneumonitis, ILD, pleural effusion eller lungefibrose diagnosticeret inden for de seneste 6 måneder før randomisering.
- Aktive eller tidligere dokumenterede autoimmune eller inflammatoriske lidelser (med undtagelser)
- Aktiv EBV-infektion eller kendt eller formodet kronisk aktiv EBV-infektion ved screening
Nuværende eller tidligere brug af immunsuppressiv medicin inden for 14 dage før den første dosis af durvalumab.
Reproduktion
- Negativ graviditetstest (serum) for WOCBP:
- Kvindelige deltagere skal være 1 år efter overgangsalderen, kirurgisk sterile eller bruge 1 yderst effektiv præventionsform
- Mandlige deltagere, der har til hensigt at være seksuelt aktive med en WOCBP, skal være kirurgisk sterile eller bruge en acceptabel præventionsmetode
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm A: Durvalumab + Domvanalimab
Durvalumab og domvanalimab som en IV-infusion q4w, startende på dag 1 i op til maksimalt 12 måneder
|
Durvalumab IV (intravenøs infusion)
Domvanalimab IV (intravenøs infusion)
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Aktiv komparator: Arm B: Durvalumab + Placebo
Durvalumab + placebo som en IV-infusion q4w startende på dag 1 i op til et maksimum på 12 måneder
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Durvalumab IV (intravenøs infusion)
Placebo IV (intravenøs infusion)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS)
Tidsramme: Up to 5 years after randomization
|
Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 50%. Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Up to 5 years after randomization
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS)
Tidsramme: Up to 5 years after randomization
|
Defined as time from randomisation until progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause in participants with PD-L1 TC ≥ 1% Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Up to 5 years after randomization
|
|
Overall Survival (OS)
Tidsramme: Approximately 5 years after randomization
|
Overall Survival (OS) Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 5 years after randomization
|
|
Objective Response Rate (ORR)
Tidsramme: Approximately 5 years after randomization
|
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 5 years after randomization
|
|
Duration of Response (DoR)
Tidsramme: Approximately 5 years after randomization
|
Duration of Response (DoR) using BICR assessment according to RECIST 1.1 Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 5 years after randomization
|
|
Time from randomization to second progression (PFS2)
Tidsramme: Approximately 5 years after randomization
|
Time from randomization to second progression (PFS2) Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 5 years after randomization
|
|
Time from randomization to first date of distant metastasis or death (TTDM)
Tidsramme: Approximately 5 years after randomization
|
Time from randomization until the first date of distant metastasis or death in the absence of distant metastasis (TTDM). Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 5 years after randomization
|
|
Time to first subsequent therapy (TFST)
Tidsramme: Approximately 5 years after randomization
|
Time to first subsequent therapy (TFST) Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 5 years after randomization
|
|
Concentration of Durvalumab and Domvanalimab
Tidsramme: Approximately 12 weeks after last IP dose
|
The pharmacokinetics (PK) of Durvalumab and Domvanalimab as determined by concentration Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 12 weeks after last IP dose
|
|
PFS6, PFS12, PFS18, PFS24
Tidsramme: Approximately 6, 12, 18 and 24 months after randomization
|
PFS at 6, 12, 18 and 24 months (proportion per Kaplan-Meier) Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 6, 12, 18 and 24 months after randomization
|
|
Anti-Drug Antibodies (ADAs)
Tidsramme: Approximately 12 weeks after last IP dose.
|
The immunogenicity of Durvalumab and domvanalimab as assessed by presence of Anti-Drug Antibodies (ADAs) Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 12 weeks after last IP dose.
|
|
Time to deterioration in pulmonary symptoms (TTFCD)
Tidsramme: Approximately 5 years after randomization
|
Time to deterioration in pulmonary symptoms (TTFCD) Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 5 years after randomization
|
|
PFS investigator
Tidsramme: Up to 5 years after randomization
|
Defined as time from randomisation until progression per RECIST 1.1 as assessed by Investigator or death due to any cause in participants Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Up to 5 years after randomization
|
|
OS 24
Tidsramme: Approximately 24 months after randomization
|
Overall Survival (OS) at 24 months Outcomes measures were applicable with the previous version of the protocol. The study objectives are considered descriptive rather than confirmatory according to the protocol amendment. |
Approximately 24 months after randomization
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hidehito Horinouchi, MD, PhD, National Cancer Center Hospital
- Ledende efterforsker: Alexander Spira, MD, PhD, Virginia Cancer Specialists Research Institute
- Ledende efterforsker: Jinming Yu, MD, PhD, Shandong Cancer Hospital And Institute
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)
18. februar 2022
Primær færdiggørelse (Faktiske)
10. august 2026
Studieafslutning (Anslået)
8. september 2027
Datoer for studieregistrering
Først indsendt
11. januar 2022
Først indsendt, der opfyldte QC-kriterier
26. januar 2022
Først opslået (Faktiske)
27. januar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D9075C00001
- 2021-004327-32 (EudraCT nummer)
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 .