Une étude comparant l'atezolizumab et le tiragolumab au durvalumab chez des participants atteints d'un cancer du poumon non à petites cellules (NSCLC) de stade III localement avancé et non résécable (SKYSCRAPER-03)
7 mai 2026 mis à jour par: Hoffmann-La Roche
Une étude de phase III, ouverte et randomisée comparant l'atezolizumab et le tiragolumab au durvalumab chez des patients atteints d'un cancer du poumon non à petites cellules de stade III localement avancé et non résécable qui n'ont pas progressé après une chimioradiothérapie concomitante à base de platine
Le but de cette étude est d'évaluer l'efficacité et l'innocuité de l'atezolizumab en association avec le tiragolumab par rapport au durvalumab chez les participants atteints d'un cancer du poumon non à petites cellules (NSCLC) de stade III localement avancé et non résécable qui ont reçu au moins deux cycles de platine- chimioradiothérapie (CRT) et n'ont pas eu de progression radiographique de la maladie.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
829
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Braunschweig, Allemagne, 38114
- Klinikum Braunschweig
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Cologne, Allemagne, 51109
- Klinikum Koeln-Merheim
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Göttingen, Allemagne, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, Allemagne, 69126
- Thoraxklinik Heidelberg gGmbH
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München, Allemagne, 81925
- Klinikum Bogenhausen
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Regensburg, Allemagne, 93053
- Universitätsklinikum Regensburg
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Buenos Aires, Argentine, C1431FWO
- CEMIC
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Ciudad Autonoma Buenos Aires, Argentine, C1284AEB
- Hospital Británico de Buenos Aires
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Córdoba, Argentine, X5004FHP
- Clínica Universitaria Reina Fabiola
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Rosario, Argentine, S2000QGB
- Sanatorio Parque S.A.
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New South Wales
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Blacktown, New South Wales, Australie, 2148
- Blacktown Hospital
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Campbelltown, New South Wales, Australie, 2560
- Macarthur Cancer Therapy Centre
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Kogarah, New South Wales, Australie, 2217
- St George Hospital
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South Australia
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Bedford Park, South Australia, Australie, 5042
- Flinders Medical Centre
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Victoria
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Victoria, Victoria, Australie, 3168
- Monash Health Translational Precinct
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Western Australia
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Bull Creek, Western Australia, Australie, 6149
- Fiona Stanley Hospital
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Charleroi, Belgique, 6000
- GHdC Site Les Viviers
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Ghent, Belgique, 9000
- AZ Maria Middelares
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Hasselt, Belgique, 3500
- Jessa Zkh (Campus Virga Jesse)
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Ceará
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Fortaleza, Ceará, Brésil, 60336-550
- CRIO - Centro Regional Integrado de Oncologia
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Paraná
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Curitiba, Paraná, Brésil, 80810-050
- Centro Integrado de Oncologia de Curitiba
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, Brésil, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Brésil, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Brésil, 14784-400
- Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, Brésil, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brésil, 01246-000
- Instituto do Câncer do Estado de São Paulo - ICESP
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British Columbia
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Abbotsford British Columbia, British Columbia, Canada, V2S 0C2
- BC Cancer ? Abbotsford
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Victoria, British Columbia, Canada, V8R 6V5
- BC Cancer - Victoria
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
- Royal Victoria Regional Health Centre
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Brampton, Ontario, Canada, L6R 3J7
- William Osler Health System Brampton Civic Hospital
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital Research Institute
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Beijing, Chine, 101149
- Beijing Chest Hospital
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Beijing, Chine, 100142
- Beijing Cancer Center
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Changchun, Chine, 132013
- Jilin cancer hospital
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Changsha, Chine, 410008
- Xiangya Hospital Central South University
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Chengdu, Chine, 610041
- Sichuan Provincial Cancer Hospital
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Chongqing, Chine, 400030
- Chongqing Cancer Hospital
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Fujian, Chine, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Chine, 350014
- Fujian Provincial Cancer Hospital
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Guangzhou, Chine, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, Chine, 310002
- Hangzhou Cancer Hospital
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Jinan, Chine, 250117
- Shandong Cancer Hospital
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Nanjing, Chine, 210009
- Zhongda Hospital Affiliated to Southeast University
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Qingdao, Chine, 266042
- The Affiliated Hospital of Qingdao University
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Shanghai, Chine, 200000
- Shanghai Chest Hospital
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Shantou, Chine, 515041
- Cancer Hospital of Shantou University Medical College
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Taiyuan, Chine, 030013
- Shanxi Provincial Cancer Hospital
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Tianjin, Chine, 300060
- Tianjin Cancer Hospital
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Wenzhou, Chine, 325000
- The 2nd School of Medicine, WMU
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Xiamen, Chine, 361003
- The First Affiliated Hospital of Xiamen University
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Xuzhou, Chine, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Zhengzhou, Chine, 450008
- Henan Cancer Hospital
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Cheongju-si, Corée du Sud, 28644
- Chungbuk National University Hospital
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Daegu, Corée du Sud, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, Corée du Sud, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Corée du Sud, 16247
- St. Vincent's Hospital
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Gyeonggi-do, Corée du Sud, 10408
- National Cancer Center
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Gyeonggi-do, Corée du Sud, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, Corée du Sud, 50612
- Pusan National University Yangsan Hospital
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Incheon, Corée du Sud, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Corée du Sud, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Corée du Sud, 03080
- Seoul National University Hospital
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Seoul, Corée du Sud, 05505
- Asan Medical Center
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Seoul, Corée du Sud, 06351
- Samsung Medical Center
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Seoul, Corée du Sud, 08308
- Korea University Guro Hospital
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Seoul, Corée du Sud, 06591
- Seoul St Mary's Hospital
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Ulsan, Corée du Sud, 44033
- Ulsan University Hosiptal
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A Coruña, Espagne, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, Espagne, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Espagne, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Espagne, 28046
- Hospital Universitario La Paz
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Madrid, Espagne, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, Espagne, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, Espagne, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Espagne, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Espagne, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, Espagne, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, Espagne, 12002
- Hospital Provincial de Castellon
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Angers, France, 49933
- CHU Angers
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Caen, France, 14000
- Centre François Baclesse
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Marseille, France, 13015
- Hopital Nord AP-HM
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Montpellier, France, 34070
- Clinique Clementville
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Vantoux, France, 57070
- Hôpital Robert Schuman
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Villejuif, France, 94805
- Institut Gustave Roussy
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Asvestochóri, Grèce, 570 10
- General Hospital "G.Papanikolaou"
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Athens, Grèce, 11527
- Sotiria Hospital
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Kifissia, Grèce, 145 64
- Agioi Anargyroi Cancer Hospital
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Hong Kong, Hong Kong
- Tuen Mun Hospital
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Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- Queen Elizabeth Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- Princess Margaret Hospital, Oncology
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Pokfulam, Hong Kong, DUMMY_VALUE
- Queen Mary Hospital
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Pécs, Hongrie, 7623
- Pecsi Tudomanyegyetem
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Tatabánya, Hongrie, 2800
- Szent Borbala Korhaz
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Törökbálint, Hongrie, 2045
- Tudogyogyintezet Torokbalint
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Beersheba, Israël, 8410100
- Soroka Medical Center
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Haifa, Israël, 3109601
- Rambam Medical Center
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Jerusalem, Israël, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, Israël, 4941492
- Rabin Medical Center
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Campania
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Naples, Campania, Italie, 80131
- Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italie, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Parma, Emilia-Romagna, Italie, 43100
- Azienda Ospedaliero Universitaria di Parma
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Lazio
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Rome, Lazio, Italie, 00128
- Policlinico Universitario Campus Biomedico
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Rome, Lazio, Italie, 00144
- IRCCS Istituto Regina Elena (IFO)
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Liguria
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Genoa, Liguria, Italie, 16132
- IRCCS AOU San Martino - IST
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Lombardy
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Brescia, Lombardy, Italie, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
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Milan, Lombardy, Italie, DUMMY_VALUE
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Pavia, Lombardy, Italie, 27100
- Fondazione IRCCS Policlinico San Matteo
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Tuscany
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Pisa, Tuscany, Italie, 56124
- Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
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Veneto
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Vicenza, Veneto, Italie, 36100
- Azienda ULSS 8 Berica
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Aichi, Japon, 464-8681
- Aichi Cancer Center
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Chiba, Japon, 277-8577
- National Cancer Center East
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Hyōgo, Japon, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, Japon, 252-0375
- Kitasato University Hospital
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Kyoto, Japon, 606-8507
- Kyoto University Hospital
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Miyagi, Japon, 981-0914
- Sendai Kousei Hospital
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Niigata, Japon, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japon, 589-8511
- Kindai University Hospital
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Saitama, Japon, 362-0806
- Saitama Cancer Center
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Shizuoka, Japon, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japon, 104-0045
- National Cancer Center Hospital
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Tokyo, Japon, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, Japon, 641-8510
- Wakayama Medical University Hospital
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Innsbruck, L'Autriche, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, L'Autriche, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, L'Autriche, 1140
- Klinik Penzing
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Coimbra, Le Portugal, 3000-075
- IPO de Coimbra
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Lisbon, Le Portugal, 1500-650
- Hospital da Luz
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Porto, Le Portugal, 4100-180
- Hospital CUF Porto
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Porto, Le Portugal, 4200-072
- IPO do Porto
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Auckland, Nouvelle-Zélande, 1023
- Auckland City Hospital, Cancer and Blood Research
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Amersfoort, Pays-Bas, 3813 TZ
- Meander Medisch Centrum
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Breda, Pays-Bas, 4819 EV
- Amphia Ziekenhuis
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Leidschendam, Pays-Bas, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
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Sittard-Geleen, Pays-Bas, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
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Gda?sk, Pologne, 80-214
- Uniwersyteckie Centrum Kliniczne
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Olsztyn, Pologne, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
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Otwock, Pologne, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Warsaw, Pologne, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
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Wroc?aw, Pologne, 53-413
- Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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Birmingham, Royaume-Uni, B9 5SS
- Birmingham Heartlands Hospital
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Cambridge, Royaume-Uni, CB2 0QQ
- Addenbrooke's NHS Trust
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Glasgow, Royaume-Uni, G12 0YN
- Beatson West of Scotland Cancer Centre
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Huddersfield, Royaume-Uni, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
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Leicester, Royaume-Uni, LE1 5WW
- Leicester Royal Infirmary
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Maidstone, Royaume-Uni, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
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Manchester, Royaume-Uni, M20 4BX
- Christie Foundation Trust
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Sheffield, Royaume-Uni, S10 2SJ
- Weston Park Hospital
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Taichung, Taïwan, 40447
- China Medical University Hospital
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Taipei, Taïwan, 112
- Taipei Veterans General Hospital
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Bangkok, Thaïlande, 10400
- Rajavithi Hospital
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Bangkok, Thaïlande, 10300
- Vajira Hospital
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Bangkok, Thaïlande, 10400
- Ramathibodi Hospital;Medicine/Oncology
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Songkhla, Thaïlande, 90110
- Songklanagarind Hospital
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Adana, Turquie (Türkiye), 01220
- Adana Baskent University Medical Faculty
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Ankara, Turquie (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, Turquie (Türkiye), 06100
- Ankara University Medical Faculty
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Ankara, Turquie (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, Turquie (Türkiye), 35100
- Ege University Medical Faculty
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Diyarbakır, Turquie (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, Turquie (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turquie (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Turquie (Türkiye), 34214
- Medipol University Medical Faculty
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Malatya, Turquie (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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California
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Palo Alto, California, États-Unis, 94305
- Stanford University
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Colorado
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Greeley, Colorado, États-Unis, 80631
- Banner MD Anderson Cancer Center
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Florida
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Fort Myers, Florida, États-Unis, 33901-8101
- Florida Cancer Specialists
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Palm Bay, Florida, États-Unis, 32901
- Cancer Care Centers of Brevard
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Pensacola, Florida, États-Unis, 32503
- Woodlands Medical Specialists, P.A.
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St. Petersburg, Florida, États-Unis, 33705
- Florida Cancer Specialist, North Region
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Georgia
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Marietta, Georgia, États-Unis, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, États-Unis, 61615
- Illinois Cancer Care
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Maine
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Brunswick, Maine, États-Unis, 04011
- New England Cancer Specialists
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Massachusetts
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Fairhaven, Massachusetts, États-Unis, 02719
- Southcoast Health System
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55404
- Minnesota Oncology Hematology
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Missouri
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Kansas City, Missouri, États-Unis, 64132
- HCA Midwest Health
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Springfield, Missouri, États-Unis, 65807
- Cox Health Systems
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Nevada
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Las Vegas, Nevada, États-Unis, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, États-Unis, 89106
- Optum Health Care
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New Jersey
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East Brunswick, New Jersey, États-Unis, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
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New Mexico
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Farmington, New Mexico, États-Unis, 87401
- San Juan Oncology Associates
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New York
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Albany, New York, États-Unis, 12208
- New York Oncology Hematology,P.C.-Albany
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New York, New York, États-Unis, 10029
- Mount Sinai Medical Center
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The Bronx, New York, États-Unis, 10461
- Montefiore Medical Center
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South Carolina
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Greenville, South Carolina, États-Unis, 29615
- Prisma Health ? Upstate
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37403
- Tennessee Oncology Chattanooga
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Nashville, Tennessee, États-Unis, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Virginia
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Fairfax, Virginia, États-Unis, 22031
- Virginia Cancer Specialists
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Norfolk, Virginia, États-Unis, 23502
- Virginia Oncology Associates
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- Statut de performance du Eastern Cooperative Oncology Group (ECOG) de 0 ou 1
- CPNPC histologiquement ou cytologiquement documenté avec CPNPC de stade III localement avancé et non résécable d'histologie pavimenteuse ou non pavimenteuse
- Tomodensitométrie par émission de positrons du corps entier (TEP-CT), effectuée avant et dans les 42 jours suivant la première dose de chimioradiothérapie concomitante (cCRT)
- Au moins deux cycles antérieurs de chimiothérapie à base de platine administrés en même temps que la radiothérapie (RT), qui doivent être terminés dans les 1 à 42 jours précédant la randomisation dans l'étude (un cycle de cCRT est défini comme 21 ou 28 jours)
- Le composant de radiothérapie (RT) dans le cCRT doit avoir été à une dose totale de rayonnement de 60 (± 10 pour cent [%]) gray (Gy) (54 Gy à 66 Gy) administrée par RT modulée en intensité (préférée) ou 3D- technique conforme
- Aucune progression pendant ou après une CRT concomitante à base de platine
- Un résultat PD-L1 connu
- Espérance de vie >/= 12 semaines
- Fonction hématologique et des organes cibles adéquate
- Les participantes doivent être disposées à éviter une grossesse pendant 90 jours après la dernière dose de tiragolumab et 5 mois après la dernière dose d'atezolizumab, ou pendant 3 mois après la dernière dose de durvalumab
- Les participants masculins doivent rester abstinents ou utiliser un préservatif pendant la période de traitement et pendant 90 jours après la dernière dose de tiragolumab
- Les participants masculins ne doivent pas donner de sperme pendant la période de traitement et pendant 90 jours après la dernière dose de tiragolumab
Critère d'exclusion:
- Tout antécédent de NSCLC antérieur et/ou tout antécédent de traitement antérieur pour le NSCLC (les participants doivent être nouvellement diagnostiqués avec une maladie de stade III non résécable)
- NSCLC connu pour avoir une mutation dans le gène du récepteur du facteur de croissance épidermique (EGFR) ou un oncogène de fusion de la kinase du lymphome anaplasique (ALK)
- Tout signe de maladie de stade IV
- Traitement par CRT séquentielle pour le NSCLC localement avancé
- Participants atteints de NSCLC localement avancé qui ont progressé pendant ou après le cCRT définitif avant la randomisation
- Toute toxicité non résolue de grade> 2 d'un CRT précédent
- Pneumopathie de grade >= 2 d'un CRT antérieur
- Actif ou antécédents de maladie auto-immune ou de déficit immunitaire
- Antécédents de fibrose pulmonaire idiopathique, de pneumonie organisée, de pneumonie d'origine médicamenteuse ou de pneumonie idiopathique ou signes de pneumonie active
- Antécédents de malignité autre que NSCLC dans les 5 ans précédant le dépistage à l'exception des malignités avec un risque négligeable de métastases ou de décès
- Antécédents de greffe allogénique de cellules souches ou d'organes solides
- Infection active par le virus Epstein-Barr (EBV) ou infection chronique active connue ou suspectée à EBV lors du dépistage
- Traitement avec un traitement expérimental dans les 28 jours précédant le début du traitement à l'étude
- Traitement antérieur avec des agonistes de CD137 ou des thérapies de blocage des points de contrôle immunitaire, y compris la protéine 4 associée aux lymphocytes T cytotoxiques, l'immunorécepteur anti-cellules T avec les domaines Ig et ITIM (anti-TIGIT), anti-PD-1 et anti-PD-L1
- Tout événement indésirable à médiation immunitaire antérieur de grade >/= 3 ou tout événement indésirable à médiation immunitaire de grade > 1 non résolu lors de la réception d'un agent d'immunothérapie antérieur autre que les agents de blocage des points de contrôle immunitaires
- Traitement avec des médicaments immunosuppresseurs systémiques
- Femmes enceintes ou allaitantes
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Atézolizumab + Tiragolumab
Les participants recevront de l'atezolizumab administré par voie intraveineuse (IV) le jour 1 de chaque cycle de 28 jours, suivi de tiragolumab administré par voie intraveineuse le jour 1 de chaque cycle de 28 jours pendant un maximum de 13 cycles.
|
L'atezolizumab 1 680 mg toutes les 4 semaines (Q4W) sera administré par voie intraveineuse le jour 1 de chaque cycle de 28 jours.
Autres noms:
Le tiragolumab 840 mg Q4W sera administré par voie IV le jour 1 de chaque cycle de 28 jours.
Autres noms:
|
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Comparateur actif: Durvalumab
Les participants recevront du durvalumab administré par voie intraveineuse au cours de chaque cycle de 28 jours pendant un maximum de 13 cycles.
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Le durvalumab sera administré en fonction du poids à 10 mg/kg IV toutes les 2 semaines (Q2W) les jours 1 et 15 de chaque cycle de 28 jours, ou sera administré à une dose fixe de 1500 mg IV toutes les 4 semaines (Q4W) ( pour les participants dont le poids >/= 30 kg) le jour 1 de chaque cycle de 28 jours.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Délai: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions.
Kaplan-Meier (K-M) method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
PFS, as Assessed by an IRF in FAS
Délai: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS) in PPAS
Délai: From randomization to death from any cause (up to approximately 57 months)
|
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
|
From randomization to death from any cause (up to approximately 57 months)
|
|
PFS, as Assessed by the Investigator in PPAS
Délai: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS
Délai: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesion & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Confirmed ORR, as Assessed by the Investigator in PPAS
Délai: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Duration of Response (DOR), as Assessed by an IRF in PPAS
Délai: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
DOR, as Assessed by the Investigator in PPAS
Délai: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Time to Confirmed Deterioration (TTCD) in Cough, as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) in PPAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first confirmed clinically meaningful deterioration (CCMD) on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Cough scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Global Health Status (GHS)/Quality-of-life (QoL), as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Core-30 (EORTC QLQ-C30) in PPAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent.
Scores were linearly transformed to a score range of 0-100.
High score for GHS/QoL scale=better health-related quality-of-life (HRQoL).
CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments/initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to a score range of 0-100.
High score for PF=high/healthy level of functioning.
CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
OS in FAS
Délai: From randomization to death from any cause (up to approximately 57 months)
|
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
|
From randomization to death from any cause (up to approximately 57 months)
|
|
PFS, as Assessed by the Investigator in FAS
Délai: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Confirmed ORR, as Assessed by an IRF in FAS
Délai: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Confirmed ORR, as Assessed by the Investigator in FAS
Délai: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
DOR, as Assessed by an IRF in FAS
Délai: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
DOR, as Assessed by the Investigator in FAS
Délai: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Cough was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent.
Scores were linearly transformed to a score range of 0-100.
High score for GHS/QoL scale=better HRQoL.
CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS
Délai: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to a score range of 0-100.
High score for PF=high/healthy level of functioning.
CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS
Délai: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS
Délai: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
OS Rate at 12, 24, 36, and 48 Months in PPAS
Délai: At Months 12, 24, 36, and 48
|
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints.
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate OS rate.
Percentages have been rounded off.
|
At Months 12, 24, 36, and 48
|
|
Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS
Délai: Up to approximately 57 months
|
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first.
Distant metastasis was defined as any new lesion that was outside of the radiation field.
K-M method was used to estimate median TTDM.
|
Up to approximately 57 months
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS
Délai: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in FAS
Délai: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
OS Rate at 12, 24, 36, and 48 Months in FAS
Délai: At Months 12, 24, 36, and 48
|
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints.
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate OS rate.
Percentages have been rounded off.
|
At Months 12, 24, 36, and 48
|
|
TTDM, as Assessed by the Investigator in FAS
Délai: Up to approximately 57 months
|
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first.
Distant metastasis was defined as any new lesion that was outside of the radiation field.
K-M method was used to estimate median TTDM.
|
Up to approximately 57 months
|
|
Number of Participants With Adverse Events (AEs)
Délai: Up to approximately 24.7 months
|
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.
|
Up to approximately 24.7 months
|
|
Number of Participants With Cytokine Release Syndrome (CRS)
Délai: Up to approximately 24.7 months
|
CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells.
Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction.
|
Up to approximately 24.7 months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Trials, Hoffmann-La Roche
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
24 août 2020
Achèvement primaire (Réel)
27 mai 2025
Achèvement de l'étude (Réel)
31 juillet 2025
Dates d'inscription aux études
Première soumission
13 août 2020
Première soumission répondant aux critères de contrôle qualité
13 août 2020
Première publication (Réel)
14 août 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Maladies pulmonaires
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pulmonaires
- Carcinome bronchique
- Tumeurs bronchiques
- Carcinome pulmonaire non à petites cellules
- Agents antinéoplasiques immunologiques
- Inhibiteurs de point de contrôle immunitaire
- Agents antinéoplasiques
- Mécanismes moléculaires d'action pharmacologique
- durvalumab
- atézolizumab
- Tiragolumab
Autres numéros d'identification d'étude
- GO41854
- 2019-004773-29 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Les chercheurs qualifiés peuvent demander l'accès aux données individuelles des patients via la plateforme de demande de données d'études cliniques (www.vivli.org).
De plus amples détails sur les critères de Roche pour les études éligibles sont disponibles ici (https://vivli.org/members/ourmembers/). Pour plus de détails sur la politique mondiale de Roche sur le partage des informations cliniques et sur la façon de demander l'accès aux documents d'études cliniques connexes, voir ici (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .