Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Uno studio globale di fase III sulla chemioterapia con Rilvegostomig o Pembrolizumab più per il trattamento di prima linea del carcinoma polmonare squamoso non a piccole cellule (NSCLC) metastatico

28 ottobre 2026 aggiornato da: AstraZeneca

Uno studio globale di fase III, randomizzato, in doppio cieco, multicentrico su rilvegostomig o pembrolizumab in combinazione con chemioterapia a base di platino per il trattamento di prima linea di pazienti con carcinoma polmonare metastatico squamoso non a piccole cellule i cui tumori esprimono PD-L1 (ARTEMIDE -Polmone02)

The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Tipo di studio

Interventistico

Iscrizione (Stimato)

1160

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.

Contatto studio

Luoghi di studio

      • Buenos Aires, Argentina, C1431FWO
        • Reclutamento
        • Research Site
      • CABA, Argentina, 1425
        • Reclutamento
        • Research Site
      • La Plata, Argentina, 1900
        • Ritirato
        • Research Site
      • Pilar, Argentina, B1629ODT
        • Reclutamento
        • Research Site
      • Rosario, Argentina, S2000DEJ
        • Reclutamento
        • Research Site
      • Darlinghurst, Australia, 2010
        • Reclutamento
        • Research Site
      • Hyde Park, Australia, 4812
        • Reclutamento
        • Research Site
      • Southport, Australia, 4215
        • Reclutamento
        • Research Site
      • Wollongong, Australia, 2500
        • Reclutamento
        • Research Site
      • Innsbruck, Austria, 6020
        • Reclutamento
        • Research Site
      • Krems, Austria, 3500
        • Reclutamento
        • Research Site
      • Rankweil, Austria, 6830
        • Reclutamento
        • Research Site
      • Vienna, Austria, 1210
        • Reclutamento
        • Research Site
      • Vienna, Austria, 1160
        • Reclutamento
        • Research Site
      • Anderlecht, Belgio, 1070
        • Ritirato
        • Research Site
      • Brussels, Belgio, 1160
        • Reclutamento
        • Research Site
      • Charleroi, Belgio, 6060
        • Reclutamento
        • Research Site
      • Kortrijk, Belgio, 8500
        • Reclutamento
        • Research Site
      • Ottignies, Belgio, 1340
        • Reclutamento
        • Research Site
      • Sint-Niklaas, Belgio, 9100
        • Ritirato
        • Research Site
      • Barretos, Brasile, 14784-400
        • Reclutamento
        • Research Site
      • Florianópolis, Brasile, 88034-000
        • Reclutamento
        • Research Site
      • Ijuí, Brasile, 98700-000
        • Reclutamento
        • Research Site
      • Londrina, Brasile, 86015-520
        • Reclutamento
        • Research Site
      • Porto Alegre, Brasile, 91350-200
        • Reclutamento
        • Research Site
      • Salvador, Brasile, 40050 410
        • Reclutamento
        • Research Site
      • São Paulo, Brasile, 01246-000
        • Reclutamento
        • Research Site
      • São Paulo, Brasile, 05652-900
        • Reclutamento
        • Research Site
      • Taubaté, Brasile, 12030-200
        • Ritirato
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Reclutamento
        • Research Site
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Reclutamento
        • Research Site
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Non ancora reclutamento
        • Research Site
      • Hamilton, Ontario, Canada, L8V 1C3
        • Reclutamento
        • Research Site
      • Sault Ste. Marie, Ontario, Canada, P6A 0A8
        • Reclutamento
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Reclutamento
        • Research Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Reclutamento
        • Research Site
      • Beijing, Cina, 100029
        • Ritirato
        • Research Site
      • Beijing, Cina, CN-100730
        • Reclutamento
        • Research Site
      • Beijing, Cina, 100142
        • Reclutamento
        • Research Site
      • Beijing, Cina, 100021
        • Reclutamento
        • Research Site
      • Beijing, Cina, 101149
        • Reclutamento
        • Research Site
      • Changchun, Cina, 130012
        • Reclutamento
        • Research Site
      • Changde, Cina, 415000
        • Reclutamento
        • Research Site
      • Changsha, Cina, 410013
        • Reclutamento
        • Research Site
      • Chengdu, Cina, 610041
        • Reclutamento
        • Research Site
      • Chengdu, Cina, 610072
        • Reclutamento
        • Research Site
      • Chongqing, Cina, 400030
        • Reclutamento
        • Research Site
      • Dalian, Cina, 116001
        • Reclutamento
        • Research Site
      • Guangzhou, Cina, 510062
        • Reclutamento
        • Research Site
      • Guangzhou, Cina, 510100
        • Reclutamento
        • Research Site
      • Hangzhou, Cina, 310003
        • Reclutamento
        • Research Site
      • Hangzhou, Cina, 310022
        • Reclutamento
        • Research Site
      • Hangzhou, Cina, 310016
        • Reclutamento
        • Research Site
      • Harbin, Cina, 150081
        • Reclutamento
        • Research Site
      • Hefei, Cina, 230601
        • Reclutamento
        • Research Site
      • Hefei, Cina, 230001
        • Reclutamento
        • Research Site
      • Jinan, Cina, 250117
        • Reclutamento
        • Research Site
      • Kunming, Cina, 650118
        • Reclutamento
        • Research Site
      • Linhai, Cina, 317000
        • Reclutamento
        • Research Site
      • Linyi, Cina, 276001
        • Reclutamento
        • Research Site
      • Nanchang, Cina, 330008
        • Reclutamento
        • Research Site
      • Ningbo, Cina, 315010
        • Reclutamento
        • Research Site
      • Shanghai, Cina, 200032
        • Reclutamento
        • Research Site
      • Shanghai, Cina, 200030
        • Reclutamento
        • Research Site
      • Shanghai, Cina, 200433
        • Reclutamento
        • Research Site
      • Shenyang, Cina, 110004
        • Ritirato
        • Research Site
      • Shenzhen, Cina, 518020
        • Ritirato
        • Research Site
      • Taiyuan, Cina, 030000
        • Reclutamento
        • Research Site
      • Tianjin, Cina, 300050
        • Reclutamento
        • Research Site
      • Wenzhou, Cina, CN-325000
        • Reclutamento
        • Research Site
      • Wuhan, Cina, 430030
        • Reclutamento
        • Research Site
      • Xi'an, Cina, 710061
        • Reclutamento
        • Research Site
      • Yangzhou, Cina, 225001
        • Reclutamento
        • Research Site
      • Yueyang, Cina, 414000
        • Reclutamento
        • Research Site
      • Zhengzhou, Cina, 450008
        • Reclutamento
        • Research Site
      • Zhengzhou, Cina, 450052
        • Reclutamento
        • Research Site
      • Changwon-si, Corea del Sud, 51353
        • Reclutamento
        • Research Site
      • Cheongju-si, Corea del Sud, 28644
        • Reclutamento
        • Research Site
      • Incheon, Corea del Sud, 21565
        • Reclutamento
        • Research Site
      • JinJoo, Corea del Sud, 52727
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 03080
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 06351
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 05505
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 03722
        • Reclutamento
        • Research Site
      • Suwon, Corea del Sud, 16247
        • Reclutamento
        • Research Site
      • Suwon, Corea del Sud, 16499
        • Reclutamento
        • Research Site
      • Avignon, Francia, 84902
        • Reclutamento
        • Research Site
      • La Rochelle, Francia, 17019
        • Reclutamento
        • Research Site
      • Lyon, Francia, 69008
        • Reclutamento
        • Research Site
      • Nîmes, Francia, 30029
        • Reclutamento
        • Research Site
      • Rennes, Francia, 35033
        • Reclutamento
        • Research Site
      • Strasbourg, Francia, 67091
        • Reclutamento
        • Research Site
      • Suresnes, Francia, 92150
        • Reclutamento
        • Research Site
      • Toulon, Francia, 83800
        • Reclutamento
        • Research Site
      • Bad Berka, Germania, 99437
        • Reclutamento
        • Research Site
      • Berlin, Germania, 13125
        • Ritirato
        • Research Site
      • Berlin, Germania, 13585
        • Ritirato
        • Research Site
      • Bielefeld, Germania, 33611
        • Non ancora reclutamento
        • Research Site
      • Bochum, Germania, 44791
        • Non ancora reclutamento
        • Research Site
      • Chemnitz, Germania, 09116
        • Non ancora reclutamento
        • Research Site
      • Cologne, Germania, 51109
        • Reclutamento
        • Research Site
      • Cologne, Germania, 50677
        • Non ancora reclutamento
        • Research Site
      • Essen, Germania, 45136
        • Non ancora reclutamento
        • Research Site
      • Esslingen am Neckar, Germania, 73730
        • Reclutamento
        • Research Site
      • Frankfurt, Germania, 60488
        • Reclutamento
        • Research Site
      • Frankfurt am Main, Germania, 60431
        • Reclutamento
        • Research Site
      • Gauting, Germania, 82131
        • Reclutamento
        • Research Site
      • Giessen, Germania, 35392
        • Reclutamento
        • Research Site
      • Großhansdorf, Germania, 22927
        • Reclutamento
        • Research Site
      • Halle, Germania, 06120
        • Non ancora reclutamento
        • Research Site
      • Hamburg, Germania, 20251
        • Reclutamento
        • Research Site
      • Hamburg, Germania, 22087
        • Non ancora reclutamento
        • Research Site
      • Hanover, Germania, 30625
        • Reclutamento
        • Research Site
      • Hanover, Germania, 30459
        • Reclutamento
        • Research Site
      • Heidelberg, Germania, 69126
        • Reclutamento
        • Research Site
      • Hemer, Germania, 58675
        • Reclutamento
        • Research Site
      • Homburg, Germania, 66424
        • Reclutamento
        • Research Site
      • Kassel, Germania, 34125
        • Reclutamento
        • Research Site
      • Kiel, Germania, 24105
        • Reclutamento
        • Research Site
      • Krefeld, Germania, 47805
        • Reclutamento
        • Research Site
      • Magdeburg, Germania, 39120
        • Non ancora reclutamento
        • Research Site
      • Minden, Germania, 32429
        • Reclutamento
        • Research Site
      • Moers, Germania, 47441
        • Reclutamento
        • Research Site
      • München, Germania, 81925
        • Reclutamento
        • Research Site
      • Oldenburg i.H., Germania, 23758
        • Non ancora reclutamento
        • Research Site
      • Regensburg, Germania, 93053
        • Reclutamento
        • Research Site
      • Schwerin, Germania, 19049
        • Non ancora reclutamento
        • Research Site
      • Velbert, Germania, 42551
        • Non ancora reclutamento
        • Research Site
      • Würzburg, Germania, 97067
        • Reclutamento
        • Research Site
      • Amagasaki-shi, Giappone, 660-8550
        • Reclutamento
        • Research Site
      • Bunkyō City, Giappone, 113-8603
        • Reclutamento
        • Research Site
      • Chūōku, Giappone, 104-0045
        • Reclutamento
        • Research Site
      • Fukuoka, Giappone, 812-8582
        • Reclutamento
        • Research Site
      • Fukuoka, Giappone, 814-0180
        • Reclutamento
        • Research Site
      • Hirakata-shi, Giappone, 573-1191
        • Non ancora reclutamento
        • Research Site
      • Hiroshima, Giappone, 734-8551
        • Reclutamento
        • Research Site
      • Kakogawa-shi, Giappone, 675-8611
        • Non ancora reclutamento
        • Research Site
      • Kanazawa, Giappone, 920-8530
        • Reclutamento
        • Research Site
      • Kawagoe-shi, Giappone, 350-8550
        • Reclutamento
        • Research Site
      • Kawasaki-shi, Giappone, 216-8511
        • Reclutamento
        • Research Site
      • Kitaadachi-gun, Giappone, 362-0806
        • Reclutamento
        • Research Site
      • Kitakyushu-shi, Giappone, 807-8555
        • Reclutamento
        • Research Site
      • Kiyose-shi, Giappone, 204-8522
        • Non ancora reclutamento
        • Research Site
      • Kobe, Giappone, 650-0017
        • Reclutamento
        • Research Site
      • Kumamoto, Giappone, 861-4193
        • Reclutamento
        • Research Site
      • Kumamoto, Giappone, 860-8556
        • Reclutamento
        • Research Site
      • Kyoto, Giappone, 612-8555
        • Reclutamento
        • Research Site
      • Kōtoku, Giappone, 135-8550
        • Reclutamento
        • Research Site
      • Matsusaka-shi, Giappone, 515-8544
        • Reclutamento
        • Research Site
      • Obihiro-shi, Giappone, 080-0024
        • Non ancora reclutamento
        • Research Site
      • Osaka, Giappone, 541-8567
        • Reclutamento
        • Research Site
      • Ota-shi, Giappone, 373-8550
        • Reclutamento
        • Research Site
      • Saitama-shi, Giappone, 338-0001
        • Reclutamento
        • Research Site
      • Sakai, Giappone, 590-0197
        • Reclutamento
        • Research Site
      • Sapporo, Giappone, 006-8555
        • Reclutamento
        • Research Site
      • Sendai, Giappone, 981-0914
        • Reclutamento
        • Research Site
      • Shinjuku-ku, Giappone, 160-0023
        • Reclutamento
        • Research Site
      • Takaoka-shi, Giappone, 933-8555
        • Reclutamento
        • Research Site
      • Yokohama, Giappone, 241-8515
        • Reclutamento
        • Research Site
      • Yokohama, Giappone, 232-0024
        • Reclutamento
        • Research Site
      • Calicut, India, 673601
        • Reclutamento
        • Research Site
      • Delhi, India, 110029
        • Reclutamento
        • Research Site
      • Gūrgaon, India, 122001
        • Reclutamento
        • Research Site
      • Kolkata, India, 700054
        • Ritirato
        • Research Site
      • Madurai, India, 625107
        • Reclutamento
        • Research Site
      • Mumbai, India, 400012
        • Non ancora reclutamento
        • Research Site
      • Nagpur, India, 440001
        • Non ancora reclutamento
        • Research Site
      • Nashik, India, 422002
        • Reclutamento
        • Research Site
      • New Delhi, India, 110075
        • Ritirato
        • Research Site
      • Puducherry, India, 605006
        • Ritirato
        • Research Site
      • Surat, India, 395017
        • Reclutamento
        • Research Site
      • Varanasi, India, 221005
        • Reclutamento
        • Research Site
      • Florence, Italia, 50134
        • Reclutamento
        • Research Site
      • Legnano, Italia, 20025
        • Non ancora reclutamento
        • Research Site
      • Livorno, Italia, 57126
        • Non ancora reclutamento
        • Research Site
      • Monza, Italia, 20900
        • Reclutamento
        • Research Site
      • Orbassano, Italia, 10043
        • Reclutamento
        • Research Site
      • Padova, Italia, 35128
        • Reclutamento
        • Research Site
      • Peschiera del Garda, Italia, 37019
        • Reclutamento
        • Research Site
      • Roma, Italia, 00168
        • Reclutamento
        • Research Site
      • George Town, Malaysia, 10450
        • Reclutamento
        • Research Site
      • Johor Bahru, Malaysia, 81100
        • Reclutamento
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Reclutamento
        • Research Site
      • Alkmaar, Olanda, 1815 JD
        • Reclutamento
        • Research Site
      • Ede, Olanda, 6716 RP
        • Reclutamento
        • Research Site
      • Groningen, Olanda, 9713 GZ
        • Ritirato
        • Research Site
      • Leidschendam, Olanda, 2262 BA
        • Reclutamento
        • Research Site
      • Veldhoven, Olanda, 5504 DB
        • Reclutamento
        • Research Site
      • Zwolle, Olanda, 8025 AB
        • Reclutamento
        • Research Site
      • Lima, Perù, L27
        • Ritirato
        • Research Site
      • Lima, Perù, 15036
        • Ritirato
        • Research Site
      • Lima, Perù, LIMA 29
        • Ritirato
        • Research Site
      • Lima, Perù, 15102
        • Ritirato
        • Research Site
      • Lima, Perù, 34
        • Ritirato
        • Research Site
      • Lima, Perù, Lima39
        • Ritirato
        • Research Site
      • Bialystok, Polonia, 15-027
        • Ritirato
        • Research Site
      • Biała Podlaska, Polonia, 21-500
        • Ritirato
        • Research Site
      • Bydgoszcz, Polonia, 85-796
        • Ritirato
        • Research Site
      • Bystra, Polonia, 43-360
        • Reclutamento
        • Research Site
      • Lodz, Polonia, 93-338
        • Reclutamento
        • Research Site
      • Lublin, Polonia, 20-090
        • Non ancora reclutamento
        • Research Site
      • Poznan, Polonia, 60-569
        • Reclutamento
        • Research Site
      • Warsaw, Polonia, 04-141
        • Reclutamento
        • Research Site
      • Wroclaw, Polonia, 53-413
        • Reclutamento
        • Research Site
      • San Juan, Porto Rico, 00918
        • Reclutamento
        • Research Site
      • San Juan, Porto Rico, 00909
        • Reclutamento
        • Research Site
      • Aberdeen, Regno Unito, AB25 2ZN
        • Reclutamento
        • Research Site
      • Cambridge, Regno Unito, CB2 0QQ
        • Reclutamento
        • Research Site
      • Edinburgh, Regno Unito, EH4 2XU
        • Reclutamento
        • Research Site
      • Exeter, Regno Unito, EX2 5DW
        • Ritirato
        • Research Site
      • Greater London, Regno Unito, SW3 6JJ
        • Reclutamento
        • Research Site
      • London, Regno Unito, EC1A 7BE
        • Reclutamento
        • Research Site
      • London, Regno Unito, SE1 9RT
        • Reclutamento
        • Research Site
      • Manchester, Regno Unito, M20 4BX
        • Reclutamento
        • Research Site
      • Newcastle upon Tyne, Regno Unito, NE7 7AF
        • Reclutamento
        • Research Site
      • Preston, Regno Unito, PR2 9HT
        • Reclutamento
        • Research Site
      • Almería, Spagna, 04009
        • Non ancora reclutamento
        • Research Site
      • Barcelona, Spagna, 8035
        • Reclutamento
        • Research Site
      • Las Palmas de Gran Canaria, Spagna, 35016
        • Reclutamento
        • Research Site
      • Lleida, Spagna, 25198
        • Reclutamento
        • Research Site
      • Madrid, Spagna, 28007
        • Reclutamento
        • Research Site
      • Madrid, Spagna, 28034
        • Reclutamento
        • Research Site
      • Majadahonda, Spagna, 28222
        • Reclutamento
        • Research Site
      • Seville, Spagna, 41013
        • Reclutamento
        • Research Site
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85724
        • Reclutamento
        • Research Site
    • Arkansas
      • Springdale, Arkansas, Stati Uniti, 72762
        • Reclutamento
        • Research Site
    • California
      • Anaheim, California, Stati Uniti, 92801
        • Reclutamento
        • Research Site
      • Beverly Hills, California, Stati Uniti, 90211
        • Reclutamento
        • Research Site
      • Loma Linda, California, Stati Uniti, 92354
        • Reclutamento
        • Research Site
      • Los Alamitos, California, Stati Uniti, 90720
        • Reclutamento
        • Research Site
      • Redlands, California, Stati Uniti, 92373
        • Reclutamento
        • Research Site
      • San Francisco, California, Stati Uniti, 94121
        • Reclutamento
        • Research Site
      • Walnut Creek, California, Stati Uniti, 94598
        • Reclutamento
        • Research Site
    • Connecticut
      • West Haven, Connecticut, Stati Uniti, 06516
        • Reclutamento
        • Research Site
    • Delaware
      • Newark, Delaware, Stati Uniti, 19713
        • Reclutamento
        • Research Site
    • Florida
      • Bay Pines, Florida, Stati Uniti, 33744
        • Reclutamento
        • Research Site
      • Fort Lauderdale, Florida, Stati Uniti, 33308
        • Reclutamento
        • Research Site
      • Gainesville, Florida, Stati Uniti, 32610
        • Ritirato
        • Research Site
      • Gainesville, Florida, Stati Uniti, 32608
        • Reclutamento
        • Research Site
      • Jacksonville, Florida, Stati Uniti, 32224
        • Reclutamento
        • Research Site
    • Georgia
      • Athens, Georgia, Stati Uniti, 30607
        • Reclutamento
        • Research Site
      • Atlanta, Georgia, Stati Uniti, 30341
        • Ritirato
        • Research Site
      • Savannah, Georgia, Stati Uniti, 31404
        • Non ancora reclutamento
        • Research Site
    • Idaho
      • Boise, Idaho, Stati Uniti, 83712
        • Reclutamento
        • Research Site
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • Reclutamento
        • Research Site
      • Decatur, Illinois, Stati Uniti, 62526
        • Reclutamento
        • Research Site
      • Hinsdale, Illinois, Stati Uniti, 60521
        • Reclutamento
        • Research Site
      • Quincy, Illinois, Stati Uniti, 62301
        • Reclutamento
        • Research Site
      • Rockford, Illinois, Stati Uniti, 61114
        • Ritirato
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, Stati Uniti, 46845
        • Non ancora reclutamento
        • Research Site
    • Iowa
      • Waterloo, Iowa, Stati Uniti, 50702
        • Reclutamento
        • Research Site
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40509
        • Reclutamento
        • Research Site
      • Lexington, Kentucky, Stati Uniti, 40536
        • Ritirato
        • Research Site
      • Louisville, Kentucky, Stati Uniti, 40207
        • Reclutamento
        • Research Site
      • Louisville, Kentucky, Stati Uniti, 40202
        • Reclutamento
        • Research Site
    • Louisiana
      • Alexandria, Louisiana, Stati Uniti, 71301
        • Ritirato
        • Research Site
      • Baton Rouge, Louisiana, Stati Uniti, 70808
        • Reclutamento
        • Research Site
      • Covington, Louisiana, Stati Uniti, 70433
        • Ritirato
        • Research Site
      • Shreveport, Louisiana, Stati Uniti, 71105
        • Reclutamento
        • Research Site
      • Shreveport, Louisiana, Stati Uniti, 71103
        • Reclutamento
        • Research Site
    • Maine
      • Scarborough, Maine, Stati Uniti, 04074
        • Reclutamento
        • Research Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21202
        • Completato
        • Research Site
      • Bethesda, Maryland, Stati Uniti, 20817
        • Reclutamento
        • Research Site
      • Bethesda, Maryland, Stati Uniti, 20889
        • Non ancora reclutamento
        • Research Site
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48202
        • Reclutamento
        • Research Site
      • Grand Rapids, Michigan, Stati Uniti, 49503
        • Reclutamento
        • Research Site
      • Saginaw, Michigan, Stati Uniti, 48602
        • Non ancora reclutamento
        • Research Site
    • Minnesota
      • Duluth, Minnesota, Stati Uniti, 55802
        • Reclutamento
        • Research Site
      • Rochester, Minnesota, Stati Uniti, 55905
        • Reclutamento
        • Research Site
    • Missouri
      • Bridgeton, Missouri, Stati Uniti, 63044
        • Reclutamento
        • Research Site
      • Columbia, Missouri, Stati Uniti, 65212
        • Ritirato
        • Research Site
      • Kansas City, Missouri, Stati Uniti, 64108
        • Reclutamento
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, Stati Uniti, 68506
        • Reclutamento
        • Research Site
    • New Jersey
      • Camden, New Jersey, Stati Uniti, 08103
        • Reclutamento
        • Research Site
    • New York
      • Buffalo, New York, Stati Uniti, 14221
        • Reclutamento
        • Research Site
      • East Syracuse, New York, Stati Uniti, 13057
        • Reclutamento
        • Research Site
      • Westbury, New York, Stati Uniti, 11590
        • Reclutamento
        • Research Site
    • North Carolina
      • Wilson, North Carolina, Stati Uniti, 27893
        • Reclutamento
        • Research Site
    • North Dakota
      • Grand Forks, North Dakota, Stati Uniti, 58201
        • Reclutamento
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45267
        • Reclutamento
        • Research Site
    • Oregon
      • Bend, Oregon, Stati Uniti, 97701
        • Ritirato
        • Research Site
      • Medford, Oregon, Stati Uniti, 97504
        • Reclutamento
        • Research Site
      • Salem, Oregon, Stati Uniti, 97301
        • Reclutamento
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, Stati Uniti, 17033
        • Reclutamento
        • Research Site
      • York, Pennsylvania, Stati Uniti, 17403
        • Reclutamento
        • Research Site
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57105
        • Reclutamento
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, Stati Uniti, 37404
        • Reclutamento
        • Research Site
      • Nashville, Tennessee, Stati Uniti, 37203
        • Reclutamento
        • Research Site
    • Texas
      • Fort Worth, Texas, Stati Uniti, 76104
        • Reclutamento
        • Research Site
      • Houston, Texas, Stati Uniti, 77090
        • Completato
        • Research Site
      • Kingwood, Texas, Stati Uniti, 77339
        • Reclutamento
        • Research Site
      • Lubbock, Texas, Stati Uniti, 79410
        • Reclutamento
        • Research Site
      • Round Rock, Texas, Stati Uniti, 78665
        • Reclutamento
        • Research Site
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Reclutamento
        • Research Site
      • Fredericksburg, Virginia, Stati Uniti, 22408
        • Reclutamento
        • Research Site
    • Washington
      • Olympia, Washington, Stati Uniti, 98506
        • Reclutamento
        • Research Site
      • Seattle, Washington, Stati Uniti, 98101
        • Reclutamento
        • Research Site
      • Silverdale, Washington, Stati Uniti, 98383
        • Ritirato
        • Research Site
      • Spokane, Washington, Stati Uniti, 99208
        • Reclutamento
        • Research Site
      • Tacoma, Washington, Stati Uniti, 98405
        • Reclutamento
        • Research Site
      • Wenatchee, Washington, Stati Uniti, 98801
        • Ritirato
        • Research Site
      • Bangkok, Tailandia, 10700
        • Reclutamento
        • Research Site
      • Chiang Mai, Tailandia, 50200
        • Reclutamento
        • Research Site
      • Dusit, Tailandia, 10300
        • Reclutamento
        • Research Site
      • Nakhon Ratchasima, Tailandia, 30000
        • Reclutamento
        • Research Site
      • Songkhla, Tailandia, 90110
        • Reclutamento
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Reclutamento
        • Research Site
      • Kaohsiung City, Taiwan, 824
        • Reclutamento
        • Research Site
      • New Taipei City, Taiwan, 220
        • Reclutamento
        • Research Site
      • New Taipei City, Taiwan, 23561
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 40705
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 402
        • Reclutamento
        • Research Site
      • Tainan, Taiwan, 73657
        • Reclutamento
        • Research Site
      • Taoyuan, Taiwan, 333
        • Reclutamento
        • Research Site
      • Ankara, Turchia (Türkiye), 6500
        • Reclutamento
        • Research Site
      • Antalya, Turchia (Türkiye), 07059
        • Reclutamento
        • Research Site
      • Istanbul, Turchia (Türkiye), 34098
        • Reclutamento
        • Research Site
      • Yenimahalle, Turchia (Türkiye), 06170
        • Reclutamento
        • Research Site
      • Budapest, Ungheria, 1121
        • Reclutamento
        • Research Site
      • Budapest, Ungheria, 1083
        • Reclutamento
        • Research Site
      • Budapest, Ungheria, 1122
        • Reclutamento
        • Research Site
      • Debrecen, Ungheria, 4032
        • Reclutamento
        • Research Site
      • Edelény, Ungheria, 3780
        • Non ancora reclutamento
        • Research Site
      • Gyöngyös, Ungheria, 3200
        • Ritirato
        • Research Site
      • Gyöngyös - Mátraháza, Ungheria, 3200
        • Reclutamento
        • Research Site
      • Győr, Ungheria, 9024
        • Reclutamento
        • Research Site
      • Pécs, Ungheria, 7624
        • Reclutamento
        • Research Site
      • Székesfehérvár, Ungheria, 8000
        • Sospeso
        • Research Site
      • Törökbálint, Ungheria, 2045
        • Reclutamento
        • Research Site
      • Can Tho, Vietnam, 900000
        • Reclutamento
        • Research Site
      • Hanoi, Vietnam, 100000
        • Reclutamento
        • Research Site
      • Ho Chi Minh City, Vietnam, 700000
        • Reclutamento
        • Research Site
      • Vinh, Vietnam, 460000
        • Reclutamento
        • Research Site

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:

  • Histologically or cytologically documented squamous NSCLC.
  • Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
  • Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved and available targeted 1L therapies.
  • Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%.
  • At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
  • Adequate organ and bone marrow function.

Exclusion Criteria:

  • Presence of small cell and neuroendocrine histology components.
  • Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
  • Any prior systemic, non-curative therapy received for NSCLC.
  • Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
  • Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
  • Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs.
  • Active primary immunodeficiency/active infectious disease(s).
  • Active tuberculosis infection.

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

Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig

Administered intravenously (IV) on Day 1 of each 21-day cycle

Altri nomi:
  • AZD2936

Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles

Comparatore attivo: Arm B

Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab

Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles

Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles

Administered intravenously (IV) on Day 1 of each 21-day cycle

Altri nomi:
  • Chiavetruda

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall survival (OS)
Lasso di tempo: Up to approximately 6 years

OS is defined as the time from randomization until the date of death due to any cause.

Up to approximately 6 years
Progression-free survival (PFS)
Lasso di tempo: Up to approximately 6 years

PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).

Up to approximately 6 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Landmark overall survival (OS) rates
Lasso di tempo: Up to approximately 6 years

OS is defined as the time from randomization until the date of death due to any cause.

Up to approximately 6 years
Landmark progression-free survival (PFS) rates
Lasso di tempo: Up to approximately 6 years

PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).

Up to approximately 6 years
Time to second progression or death (PFS2)
Lasso di tempo: Up to approximately 6 years

PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice.

Up to approximately 6 years
Overall response rate (ORR)
Lasso di tempo: Up to approximately 6 years

ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).

Up to approximately 6 years
Duration of response (DoR)
Lasso di tempo: Up to approximately 6 years

DoR is defined as the time from the date of first documented response until the date of documented progression using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression).

Up to approximately 6 years
Pharmacokinetic (PK) of rilvegostomig
Lasso di tempo: Up to approximately 6 years

Concentration of rilvegostomig in serum.

Up to approximately 6 years
Immunogenicity of rilvegostomig
Lasso di tempo: Up to approximately 6 years

Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.

Up to approximately 6 years
Patient-reported physical functioning
Lasso di tempo: Up to approximately 6 years

Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point.

Up to approximately 6 years
Patient-reported global health status (GHS)/quality of life (QoL)
Lasso di tempo: Up to approximately 6 years

Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold.

Up to approximately 6 years
Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)
Lasso di tempo: Up to approximately 6 years

Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ).

TTD is defined as time from randomization to the date of first deterioration.

Up to approximately 6 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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)

18 novembre 2024

Completamento primario (Stimato)

1 luglio 2030

Completamento dello studio (Stimato)

1 luglio 2030

Date di iscrizione allo studio

Primo inviato

4 ottobre 2024

Primo inviato che soddisfa i criteri di controllo qualità

14 novembre 2024

Primo Inserito (Effettivo)

18 novembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • D702BC00001
  • 2024-514281-39-00 (Identificatore di registro: CTIS (EU))

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 (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for Important Protocol Deviation (IPD), but this does not mean all requests will be approved.

Periodo di condivisione IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the European Federation of Pharmaceutical Industries and Associations (EFPIA)/Pharmaceutical Research and Manufacturers of America (PhRMA) Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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. A 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 .