Uno studio globale per valutare gli effetti di durvalumab con oleclumab o durvalumab con monalizumab in seguito a chemioradioterapia concomitante in pazienti con carcinoma polmonare non a piccole cellule non resecabile in stadio III (PACIFIC-9)
3 novembre 2026 aggiornato da: AstraZeneca
Uno studio internazionale di fase III, in doppio cieco, controllato con placebo, randomizzato, multicentrico su Durvalumab Plus Oleclumab e Durvalumab Plus Monalizumab in pazienti con carcinoma polmonare non a piccole cellule (NSCLC) localmente avanzato (Stadio III), non resecabile che non sono progrediti A seguito di terapia chemioradioterapica concomitante definitiva a base di platino
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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1051
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Box Hill, Australia, 3128
- Research Site
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East Melbourne, Australia, 3002
- Research Site
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Elizabeth Vale, Australia, 5112
- Research Site
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Gosford, Australia, 2250
- Research Site
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Heidelberg, Australia, 3084
- Research Site
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Kogarah, Australia, 2217
- Research Site
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South Brisbane, Australia, 4101
- Research Site
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St Albans, Australia, 3021
- Research Site
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Westmead, Australia, 2145
- Research Site
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Barretos, Brasile, 14784-400
- Research Site
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Belo Horizonte, Brasile, 30380-090
- Research Site
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Florianópolis, Brasile, 88034-000
- Research Site
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Fortaleza, Brasile, 60336-232
- Research Site
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Jaú, Brasile, 17210-120
- Research Site
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Natal, Brasile, 59075-740
- Research Site
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Porto Alegre, Brasile, 91350-200
- Research Site
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Porto Alegre, Brasile, 90610-001
- Research Site
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Recife, Brasile, 52010-075
- Research Site
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São Paulo, Brasile, 01323-903
- Research Site
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Uberlândia, Brasile, 38408-150
- Research Site
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Vitória, Brasile, 29043-260
- Research Site
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Research Site
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
- Research Site
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Hamilton, Ontario, Canada, L8V 5C2
- Research Site
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Kingston, Ontario, Canada, K7L 2V7
- Research Site
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London, Ontario, Canada, N6A 5W9
- Research Site
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Mississauga, Ontario, Canada, L5M 2N1
- Research Site
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Toronto, Ontario, Canada, M5G 2M9
- Research Site
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Quebec
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Rimouski, Quebec, Canada, G5L 5T1
- Research Site
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Anyang, Cina, 455000
- Research Site
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Beijing, Cina, 100021
- Research Site
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Changchun, Cina, 130021
- Research Site
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Changsha, Cina, 410013
- Research Site
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Changsha, Cina, 410008
- Research Site
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Guangzhou, Cina, 510060
- Research Site
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Guangzhou, Cina, 510062
- Research Site
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Guangzhou, Cina, 510700
- Research Site
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Hangzhou, Cina, 310022
- Research Site
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Hangzhou, Cina, 310002
- Research Site
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Hefei, Cina, 230031
- Research Site
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Hefei, Cina, 133500
- Research Site
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Kunming, Cina, 650118
- Research Site
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Linhai, Cina, 317000
- Research Site
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Nanchang, Cina, 330006
- Research Site
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Nanning, Cina, 530021
- Research Site
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Nantong, Cina, 226361
- Research Site
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Neijiang, Cina, 641000
- Research Site
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Ningbo, Cina, 315100
- Research Site
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Shaoguan, Cina, 512027
- Research Site
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Tianjin, Cina, 300060
- Research Site
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Wuhan, Cina, 430079
- Research Site
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Wuhan, Cina, 430022
- Research Site
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Wuhan, Cina, 430071
- Research Site
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Zhanjiang, Cina, 524001
- Research Site
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Zhengzhou, Cina, 450008
- Research Site
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Zhengzhou, Cina, 450000
- Research Site
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Zhongshan, Cina, 528403
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Barranquilla, Colombia, 080020
- Research Site
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Bogota D.C., Colombia, 110131
- Research Site
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Medellín, Colombia, 050034
- Research Site
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Valledupar, Colombia, 200001
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Changwon-si, Corea del Sud, 51353
- Research Site
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Cheongju-si, Corea del Sud, 28644
- Research Site
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Seongnam-si, Corea del Sud, 13620
- Research Site
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Seoul, Corea del Sud, 03080
- Research Site
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Seoul, Corea del Sud, 03722
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Seoul, Corea del Sud, 05505
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Suwon, Corea del Sud, 16499
- Research Site
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Suwon, Corea del Sud, 16247
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Avignon, Francia, 84918
- Research Site
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Besançon, Francia, 25030
- Research Site
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Bordeaux, Francia, 33075
- Research Site
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Clermont-Ferrand, Francia, 63000
- Research Site
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Créteil, Francia, 94010
- Research Site
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Lorient, Francia, 56322
- Research Site
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Marseille, Francia, 13015
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Montpellier, Francia, 34298
- Research Site
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Rennes, Francia, 35033
- Research Site
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Rouen, Francia, 76031
- Research Site
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Toulouse, Francia, 31059
- Research Site
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Villejuif, Francia, 94805
- Research Site
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Erfurt, Germania, 99089
- Research Site
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Erlangen, Germania, 91054
- Research Site
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Essen, Germania, 45147
- Research Site
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Esslingen am Neckar, Germania, 73730
- Research Site
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Georgsmarienhütte, Germania, 49124
- Research Site
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Gütersloh, Germania, 33332
- Research Site
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Hanover, Germania, 30459
- Research Site
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Oldenburg, Germania, 26121
- Research Site
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Würzburg, Germania, 97080
- Research Site
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Himeji-shi, Giappone, 670-8520
- Research Site
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Hiroshima, Giappone, 730-0011
- Research Site
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Kashiwa, Giappone, 227-8577
- Research Site
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Kurume-shi, Giappone, 830-0011
- Research Site
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Natori-shi, Giappone, 981-1293
- Research Site
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Niigata, Giappone, 951-8566
- Research Site
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Osaka, Giappone, 541-8567
- Research Site
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Sendai, Giappone, 980-0873
- Research Site
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Tokushima, Giappone, 770-8503
- Research Site
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Toon-shi, Giappone, 791-0295
- Research Site
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Wakayama, Giappone, 641-8510
- Research Site
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Brescia, Italia, 25123
- Research Site
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Florence, Italia, 50134
- Research Site
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Lucca, Italia, 55100
- Research Site
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Meldola, Italia, 47014
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Orbassano, Italia, 10043
- Research Site
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Parma, Italia, 43126
- Research Site
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Pavia, Italia, 27100
- Research Site
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Roma, Italia, 00128
- Research Site
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Lima, Perù, Lima 32
- Research Site
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Lima, Perù, 15038
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Lima, Perù, Lima 34
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Bydgoszcz, Polonia, 85-796
- Research Site
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Gdansk, Polonia, 80-952
- Research Site
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Koszalin, Polonia, 75-581
- Research Site
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Poznan, Polonia, 60-569
- Research Site
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Siedlce, Polonia, 08-110
- Research Site
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Tomaszów Mazowiecki, Polonia, 97-200
- Research Site
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Warsaw, Polonia, 02-781
- Research Site
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Lisbon, Portogallo, 1998-018
- Research Site
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Lisbon, Portogallo, 1769-001
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Lisbon, Portogallo, 1099-023
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Lisbon, Portogallo, 1400-038
- Research Site
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Loures, Portogallo, 2674-514
- Research Site
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Porto, Portogallo, 4200-319
- Research Site
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Belfast, Regno Unito, BT9 7AB
- Research Site
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Bristol, Regno Unito, BS2 8ED
- Research Site
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Dundee, Regno Unito, DD1 9SY
- Research Site
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Edinburgh, Regno Unito, EH4 2XR
- Research Site
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London, Regno Unito, W6 8RF
- Research Site
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London, Regno Unito, NW1 2PG
- Research Site
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Middlesbrough, Regno Unito, TS4 3BW
- Research Site
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Poole, Regno Unito, BH15 2JB
- Research Site
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Torquay, Regno Unito, TQ2 7AA
- Research Site
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Truro, Regno Unito, TR1 3LJ
- Research Site
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Wolverhampton, Regno Unito, WV10 OQP
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Barcelona, Spagna, 8035
- Research Site
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Barcelona, Spagna, 8003
- Research Site
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Granada, Spagna, 18016
- Research Site
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Madrid, Spagna, 28034
- Research Site
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Madrid, Spagna, 28040
- Research Site
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Santiago de Compostela, Spagna, 15706
- Research Site
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Valencia, Spagna, 46010
- Research Site
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California
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San Diego, California, Stati Uniti, 92123
- Research Site
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06510
- Research Site
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Florida
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Stuart, Florida, Stati Uniti, 34994
- Research Site
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Illinois
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Urbana, Illinois, Stati Uniti, 61801
- Research Site
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Indiana
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New Albany, Indiana, Stati Uniti, 47150
- Research Site
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40503
- Research Site
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Louisville, Kentucky, Stati Uniti, 40241
- Research Site
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Maryland
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Annapolis, Maryland, Stati Uniti, 21401
- Research Site
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Baltimore, Maryland, Stati Uniti, 21201
- Research Site
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Baltimore, Maryland, Stati Uniti, 21229
- Research Site
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Bethesda, Maryland, Stati Uniti, 20817
- Research Site
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Michigan
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Grand Rapids, Michigan, Stati Uniti, 49503
- Research Site
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Minnesota
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Duluth, Minnesota, Stati Uniti, 55805
- Research Site
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Montana
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Billings, Montana, Stati Uniti, 59101
- Research Site
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New Jersey
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Ridgewood, New Jersey, Stati Uniti, 07450
- Research Site
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New York
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Ithaca, New York, Stati Uniti, 14850
- Research Site
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North Carolina
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Greensboro, North Carolina, Stati Uniti, 27403
- Research Site
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- Research Site
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Cleveland, Ohio, Stati Uniti, 44124
- Research Site
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Maumee, Ohio, Stati Uniti, 43537
- Research Site
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Research Site
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York, Pennsylvania, Stati Uniti, 17403
- Research Site
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South Dakota
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Sioux Falls, South Dakota, Stati Uniti, 57105
- Research Site
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Texas
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Houston, Texas, Stati Uniti, 77030
- Research Site
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Virginia
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Charlottesville, Virginia, Stati Uniti, 22908
- Research Site
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Fairfax, Virginia, Stati Uniti, 22031
- Research Site
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Fredericksburg, Virginia, Stati Uniti, 22408
- Research Site
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Richmond, Virginia, Stati Uniti, 23235
- Research Site
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Washington
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Richland, Washington, Stati Uniti, 99352
- Research Site
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Spokane, Washington, Stati Uniti, 99204
- Research Site
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Tacoma, Washington, Stati Uniti, 98405
- Research Site
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Research Site
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Bangkok, Tailandia, 10300
- Research Site
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Bangkok, Tailandia, 10700
- Research Site
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Hat Yai, Tailandia, 90110
- Research Site
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Khon Kaen, Tailandia, 40002
- Research Site
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Khon Kaen, Tailandia, 40000
- Research Site
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Lampang, Tailandia, 52000
- Research Site
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Muang, Tailandia, 50200
- Research Site
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Muang, Tailandia, 22000
- Research Site
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Mueang, Tailandia, 20000
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Naimuang, Tailandia, 30000
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Hsinchu, Taiwan, 300
- Research Site
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New Taipei City, Taiwan, 23561
- Research Site
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Taichung, Taiwan, 40705
- Research Site
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Taichung, Taiwan, 402
- Research Site
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Taipei, Taiwan
- Research Site
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Taipei, Taiwan, 11490
- Research Site
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Taoyuan City, Taiwan, 333
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Ankara, Turchia (Türkiye), 06230
- Research Site
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Ankara, Turchia (Türkiye), 06800
- Research Site
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Ankara, Turchia (Türkiye), 06010
- Research Site
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Cordaleo, Turchia (Türkiye), 35575
- Research Site
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Diyarbakır, Turchia (Türkiye), 21280
- Research Site
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Goztepe Istanbul, Turchia (Türkiye)
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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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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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) |
|
Sperimentale: 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) |
|
Comparatore attivo: 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) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression Free Surival (PFS)
Lasso di tempo: Up to 5 years after first patient randomized.
|
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1. |
Up to 5 years after first patient randomized.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival (OS)
Lasso di tempo: Up to 9 years after first patient randomized
|
Overall survival (OS) |
Up to 9 years after first patient randomized
|
|
Objective response rate (ORR)
Lasso di tempo: Up to 5 years after first patient randomized
|
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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Fabrice Barlesi, MD, Gustave Roussy, Cancer Campus, Grand Paris
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
7 febbraio 2022
Completamento primario (Stimato)
8 gennaio 2027
Completamento dello studio (Stimato)
2 luglio 2030
Date di iscrizione allo studio
Primo inviato
14 gennaio 2022
Primo inviato che soddisfa i criteri di controllo qualità
2 febbraio 2022
Primo Inserito (Effettivo)
3 febbraio 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 novembre 2026
Ultimo verificato
1 ottobre 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D9078C00001
- 2021-004346-37 (Numero EudraCT)
- 2023-503999-24-00 (Identificatore di registro: Clinical Trial Information System (CTIS))
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
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.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .