En global undersøgelse for at vurdere virkningerne af Durvalumab med Oleclumab eller Durvalumab med Monalizumab efter samtidig kemoradiation hos patienter med trin III uoperabel ikke-småcellet lungekræft (PACIFIC-9)
3. november 2026 opdateret af: AstraZeneca
En fase III, dobbeltblind, placebokontrolleret, randomiseret, multicenter, international undersøgelse af Durvalumab Plus Oleclumab og Durvalumab Plus Monalizumab hos patienter med lokalt fremskreden (stadium III), uoperabel ikke-småcellet lungekræft (NSCLC), som ikke har udviklet sig Efter endelig, platinbaseret samtidig kemoradiationsterapi
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1051
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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Box Hill, Australien, 3128
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East Melbourne, Australien, 3002
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Elizabeth Vale, Australien, 5112
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Gosford, Australien, 2250
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Heidelberg, Australien, 3084
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Kogarah, Australien, 2217
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South Brisbane, Australien, 4101
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St Albans, Australien, 3021
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Westmead, Australien, 2145
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Barretos, Brasilien, 14784-400
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Belo Horizonte, Brasilien, 30380-090
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Florianópolis, Brasilien, 88034-000
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Fortaleza, Brasilien, 60336-232
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Jaú, Brasilien, 17210-120
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Natal, Brasilien, 59075-740
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Porto Alegre, Brasilien, 91350-200
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Porto Alegre, Brasilien, 90610-001
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Recife, Brasilien, 52010-075
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São Paulo, Brasilien, 01323-903
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Uberlândia, Brasilien, 38408-150
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Vitória, Brasilien, 29043-260
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
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Hamilton, Ontario, Canada, L8V 5C2
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Kingston, Ontario, Canada, K7L 2V7
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London, Ontario, Canada, N6A 5W9
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Mississauga, Ontario, Canada, L5M 2N1
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Toronto, Ontario, Canada, M5G 2M9
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Quebec
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Rimouski, Quebec, Canada, G5L 5T1
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Barranquilla, Colombia, 080020
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Bogota D.C., Colombia, 110131
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Medellín, Colombia, 050034
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Valledupar, Colombia, 200001
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Belfast, Det Forenede Kongerige, BT9 7AB
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Bristol, Det Forenede Kongerige, BS2 8ED
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Dundee, Det Forenede Kongerige, DD1 9SY
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Edinburgh, Det Forenede Kongerige, EH4 2XR
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London, Det Forenede Kongerige, W6 8RF
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London, Det Forenede Kongerige, NW1 2PG
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Middlesbrough, Det Forenede Kongerige, TS4 3BW
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Poole, Det Forenede Kongerige, BH15 2JB
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Torquay, Det Forenede Kongerige, TQ2 7AA
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Truro, Det Forenede Kongerige, TR1 3LJ
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Wolverhampton, Det Forenede Kongerige, WV10 OQP
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California
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San Diego, California, Forenede Stater, 92123
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
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Florida
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Stuart, Florida, Forenede Stater, 34994
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Illinois
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Urbana, Illinois, Forenede Stater, 61801
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Indiana
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New Albany, Indiana, Forenede Stater, 47150
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
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Louisville, Kentucky, Forenede Stater, 40241
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Maryland
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Annapolis, Maryland, Forenede Stater, 21401
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Baltimore, Maryland, Forenede Stater, 21201
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Baltimore, Maryland, Forenede Stater, 21229
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Bethesda, Maryland, Forenede Stater, 20817
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49503
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Minnesota
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Duluth, Minnesota, Forenede Stater, 55805
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Montana
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Billings, Montana, Forenede Stater, 59101
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New Jersey
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Ridgewood, New Jersey, Forenede Stater, 07450
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New York
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Ithaca, New York, Forenede Stater, 14850
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North Carolina
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Greensboro, North Carolina, Forenede Stater, 27403
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Ohio
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Cleveland, Ohio, Forenede Stater, 44195
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Cleveland, Ohio, Forenede Stater, 44124
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Maumee, Ohio, Forenede Stater, 43537
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Oregon
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Portland, Oregon, Forenede Stater, 97239
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
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York, Pennsylvania, Forenede Stater, 17403
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
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Texas
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Houston, Texas, Forenede Stater, 77030
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
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Fairfax, Virginia, Forenede Stater, 22031
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Fredericksburg, Virginia, Forenede Stater, 22408
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Richmond, Virginia, Forenede Stater, 23235
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Washington
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Richland, Washington, Forenede Stater, 99352
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Spokane, Washington, Forenede Stater, 99204
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Tacoma, Washington, Forenede Stater, 98405
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
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Avignon, Frankrig, 84918
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Besançon, Frankrig, 25030
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Bordeaux, Frankrig, 33075
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Clermont-Ferrand, Frankrig, 63000
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Créteil, Frankrig, 94010
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Lorient, Frankrig, 56322
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Marseille, Frankrig, 13015
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Montpellier, Frankrig, 34298
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Rennes, Frankrig, 35033
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Rouen, Frankrig, 76031
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Toulouse, Frankrig, 31059
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Villejuif, Frankrig, 94805
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Brescia, Italien, 25123
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Florence, Italien, 50134
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Lucca, Italien, 55100
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Meldola, Italien, 47014
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Orbassano, Italien, 10043
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Parma, Italien, 43126
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Pavia, Italien, 27100
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Roma, Italien, 00128
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Himeji-shi, Japan, 670-8520
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Hiroshima, Japan, 730-0011
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Kashiwa, Japan, 227-8577
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Kurume-shi, Japan, 830-0011
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Natori-shi, Japan, 981-1293
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Niigata, Japan, 951-8566
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Osaka, Japan, 541-8567
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Sendai, Japan, 980-0873
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Tokushima, Japan, 770-8503
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Toon-shi, Japan, 791-0295
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Wakayama, Japan, 641-8510
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Anyang, Kina, 455000
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Beijing, Kina, 100021
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Changchun, Kina, 130021
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Changsha, Kina, 410013
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Changsha, Kina, 410008
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Guangzhou, Kina, 510060
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Guangzhou, Kina, 510062
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Guangzhou, Kina, 510700
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Hangzhou, Kina, 310022
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Hangzhou, Kina, 310002
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Hefei, Kina, 230031
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Hefei, Kina, 133500
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Kunming, Kina, 650118
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Linhai, Kina, 317000
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Nanchang, Kina, 330006
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Nanning, Kina, 530021
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Nantong, Kina, 226361
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Neijiang, Kina, 641000
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Ningbo, Kina, 315100
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Shaoguan, Kina, 512027
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Tianjin, Kina, 300060
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Wuhan, Kina, 430079
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Wuhan, Kina, 430022
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Wuhan, Kina, 430071
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Zhanjiang, Kina, 524001
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Zhengzhou, Kina, 450008
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Zhengzhou, Kina, 450000
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Zhongshan, Kina, 528403
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Lima, Peru, Lima 32
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Lima, Peru, 15038
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Lima, Peru, Lima 34
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Bydgoszcz, Polen, 85-796
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Gdansk, Polen, 80-952
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Koszalin, Polen, 75-581
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Poznan, Polen, 60-569
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Siedlce, Polen, 08-110
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Tomaszów Mazowiecki, Polen, 97-200
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Warsaw, Polen, 02-781
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Lisbon, Portugal, 1998-018
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Lisbon, Portugal, 1769-001
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Lisbon, Portugal, 1099-023
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Lisbon, Portugal, 1400-038
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Loures, Portugal, 2674-514
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Porto, Portugal, 4200-319
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Barcelona, Spanien, 8035
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Barcelona, Spanien, 8003
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Granada, Spanien, 18016
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Madrid, Spanien, 28034
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Madrid, Spanien, 28040
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Santiago de Compostela, Spanien, 15706
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Valencia, Spanien, 46010
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Changwon-si, Sydkorea, 51353
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Cheongju-si, Sydkorea, 28644
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Seongnam-si, Sydkorea, 13620
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Seoul, Sydkorea, 03080
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Seoul, Sydkorea, 03722
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Seoul, Sydkorea, 05505
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Suwon, Sydkorea, 16499
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Suwon, Sydkorea, 16247
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Hsinchu, Taiwan, 300
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New Taipei City, Taiwan, 23561
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Taichung, Taiwan, 40705
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Taichung, Taiwan, 402
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Taipei, Taiwan
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Taipei, Taiwan, 11490
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Taoyuan City, Taiwan, 333
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Bangkok, Thailand, 10300
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Bangkok, Thailand, 10700
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Hat Yai, Thailand, 90110
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Khon Kaen, Thailand, 40002
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Khon Kaen, Thailand, 40000
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Lampang, Thailand, 52000
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Muang, Thailand, 50200
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Muang, Thailand, 22000
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Mueang, Thailand, 20000
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Naimuang, Thailand, 30000
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Ankara, Tyrkiet (Türkiye), 06230
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Ankara, Tyrkiet (Türkiye), 06800
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Ankara, Tyrkiet (Türkiye), 06010
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Cordaleo, Tyrkiet (Türkiye), 35575
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Diyarbakır, Tyrkiet (Türkiye), 21280
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Goztepe Istanbul, Tyrkiet (Türkiye)
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Erfurt, Tyskland, 99089
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Erlangen, Tyskland, 91054
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Essen, Tyskland, 45147
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Esslingen am Neckar, Tyskland, 73730
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Georgsmarienhütte, Tyskland, 49124
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Gütersloh, Tyskland, 33332
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Hanover, Tyskland, 30459
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Oldenburg, Tyskland, 26121
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Würzburg, Tyskland, 97080
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Haiphong, Vietnam, 180000
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Hanoi, Vietnam, 100000
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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
Køn, der er berettiget til at studere
Alle
Beskrivelse
INCLUSION CRITERIA:
- Participant must be ≥ 18 years at the time of screening.
- Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
- Provision of a tumour tissue sample obtained prior to CRT
- Documented tumour PD-L1 status by central lab
- Documented EGFR and ALK wild-type status (local or central).
- Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
- Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
- Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
- WHO performance status of 0 or 1 at randomization
- Adequate organ and marrow function
EXCLUSION CRITERIA:
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.
- Mixed small cell and non-small cell lung cancer histology.
- Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
- Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
- Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
- Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization.
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
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 |
|---|---|
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Eksperimentel: Arm A: Durvalumab and Oleclumab
Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months |
Durvalumab IV (intravenous infusion) Oleclumab IV (intravenous infusion) |
|
Eksperimentel: Arm B: Durvalumab and Monalizumab
Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only |
Durvalumab IV (intravenous infusion) Monalizumab IV (intravenous infusion) Placebo IV (intravenous infusion) |
|
Aktiv komparator: Arm C: Durvalumab and Placebo
Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months |
Durvalumab IV (intravenous infusion) Placebo IV (intravenous infusion) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Surival (PFS)
Tidsramme: Up to 5 years after first patient randomized.
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Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1. |
Up to 5 years after first patient randomized.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to 9 years after first patient randomized
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Overall survival (OS) |
Up to 9 years after first patient randomized
|
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Objective response rate (ORR)
Tidsramme: Up to 5 years after first patient randomized
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Objective response rate (ORR) per RECIST 1.1 as assessed by BICR |
Up to 5 years after first patient randomized
|
|
Overall survival (OS) at 24 months
Tidsramme: Up to 9 years after first patient randomized
|
Overall survival (OS) at 24 months |
Up to 9 years after first patient randomized
|
|
Duration of response (DoR)
Tidsramme: Up to 5 years after first patient randomized
|
Duration of response (DoR) per RECIST 1.1 as assessed by BICR |
Up to 5 years after first patient randomized
|
|
Progression free survival (PFS) at 6, 12, 18, and 24 months
Tidsramme: From date of randomization until 24 months
|
Progression free survival (PFS) at 6, 12, 18, and 24 months respectively, per RECIST 1.1 as assessed by BICR |
From date of randomization until 24 months
|
|
Time from randomization to second progression (PFS2)
Tidsramme: Up to 5 years after first patient randomized
|
Time from randomization to second progression (PFS2) |
Up to 5 years after first patient randomized
|
|
Time from randomization to first date of distant metastasis or death (TTDM)
Tidsramme: Up to 5 years after first patient randomized
|
Time from randomization to first date of distant metastasis or death (TTDM) |
Up to 5 years after first patient randomized
|
|
Time from randomization to start date of first subsequent therapy (TFST)
Tidsramme: Up to 9 years after first patient randomized
|
Time from randomization to start date of first subsequent therapy (TFST) |
Up to 9 years after first patient randomized
|
|
Progression free survival (PFS) as assessed by Investigator
Tidsramme: Up to 5 years after first patient randomized
|
Progression free survival (PFS) as assessed by Investigator |
Up to 5 years after first patient randomized
|
|
IHC analysis of PD-L1 TC expression
Tidsramme: Up to 5 years after first patient randomized
|
IHC analysis of PD-L1 TC expression relative to efficacy outcomes |
Up to 5 years after first patient randomized
|
|
Concentration of Durvalumab
Tidsramme: From date of randomization until 3 months after date of last IP dose
|
To assess the Pharmacokinetics of Durvalumab when in combination with Monalizumab or Oleclumab - serum peak and trough concentrations |
From date of randomization until 3 months after date of last IP dose
|
|
Anti-drug antibodies (ADAs)
Tidsramme: From date of randomization until 3 months after date of last IP dose
|
The immunogenicity of durvalumab, oleclumab, and monalizumab as assessed by presence of anti-drug antibodies (ADAs) |
From date of randomization until 3 months after date of last IP dose
|
|
Time to deterioration in pulmonary symptoms (TTFCD)
Tidsramme: Up to 5 years after last patient randomized
|
Time to deterioration in pulmonary symptoms (TTFCD) |
Up to 5 years after last patient randomized
|
|
Concentration of Oleclumab
Tidsramme: From date of randomization until 3 months after last dose of IP
|
To assess the Pharmacokinetics of Oleclumab when in combination with Durvulumab - serum peak and trough concentrations |
From date of randomization until 3 months after last dose of IP
|
|
Concentration of Monalizumab
Tidsramme: From date of randomization until 3 months after last dose of IP
|
To assess the Pharmacokinetics of Monalizumab when in combination with Durvalumab - serum peak and trough concentrations |
From date of randomization until 3 months after last dose of IP
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Fabrice Barlesi, MD, Gustave Roussy, Cancer Campus, Grand Paris
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.
Hjælpsomme links
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)
7. februar 2022
Primær færdiggørelse (Anslået)
8. januar 2027
Studieafslutning (Anslået)
2. juli 2030
Datoer for studieregistrering
Først indsendt
14. januar 2022
Først indsendt, der opfyldte QC-kriterier
2. februar 2022
Først opslået (Faktiske)
3. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D9078C00001
- 2021-004346-37 (EudraCT nummer)
- 2023-503999-24-00 (Registry Identifier: Clinical Trial Information System (CTIS))
- 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 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 IPD, but this does not mean all requests will be shared.
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .