Uno studio su atezolizumab e tiragolumab rispetto a durvalumab in partecipanti con carcinoma polmonare non a piccole cellule (NSCLC) localmente avanzato e non resecabile in stadio III (SKYSCRAPER-03)
7 maggio 2026 aggiornato da: Hoffmann-La Roche
Uno studio di fase III, in aperto, randomizzato su atezolizumab e tiragolumab rispetto a durvalumab in pazienti con carcinoma polmonare non a piccole cellule in stadio III localmente avanzato e non resecabile che non sono progrediti dopo chemioradioterapia concomitante a base di platino
Lo scopo di questo studio è valutare l'efficacia e la sicurezza di atezolizumab in combinazione con tiragolumab rispetto a durvalumab nei partecipanti con carcinoma polmonare non a piccole cellule (NSCLC) di stadio III localmente avanzato e non resecabile che hanno ricevuto almeno due cicli concomitanti di platino- chemioradioterapia (CRT) e non hanno avuto progressione radiografica della malattia.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
829
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina, C1431FWO
- Cemic
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Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
- Hospital Britanico de Buenos Aires
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Córdoba, Argentina, X5004FHP
- Clinica Universitaria Reina Fabiola
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Rosario, Argentina, S2000QGB
- Sanatorio Parque S.A.
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Blacktown Hospital
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Campbelltown, New South Wales, Australia, 2560
- Macarthur Cancer Therapy Centre
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Kogarah, New South Wales, Australia, 2217
- St George Hospital
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Flinders Medical Centre
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Victoria
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Victoria, Victoria, Australia, 3168
- Monash Health Translational Precinct
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Western Australia
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Bull Creek, Western Australia, Australia, 6149
- Fiona Stanley Hospital
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Innsbruck, Austria, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, Austria, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, Austria, 1140
- Klinik Penzing
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Charleroi, Belgio, 6000
- GHdC Site Les Viviers
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Ghent, Belgio, 9000
- AZ Maria Middelares
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Hasselt, Belgio, 3500
- Jessa Zkh (Campus Virga Jesse)
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Ceará
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Fortaleza, Ceará, Brasile, 60336-550
- Crio - Centro Regional Integrado de Oncologia
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Paraná
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Curitiba, Paraná, Brasile, 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, Brasile, 98700-000
- Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Brasile, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Brasile, 14784-400
- Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, Brasile, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brasile, 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, Cina, 101149
- Beijing Chest Hospital
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Beijing, Cina, 100142
- Beijing Cancer Center
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Changchun, Cina, 132013
- Jilin Cancer Hospital
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Changsha, Cina, 410008
- Xiangya Hospital Central South University
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Chengdu, Cina, 610041
- Sichuan Provincial Cancer Hospital
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Chongqing, Cina, 400030
- Chongqing Cancer Hospital
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Fujian, Cina, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Cina, 350014
- Fujian Provincial Cancer Hospital
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Guangzhou, Cina, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, Cina, 310002
- Hangzhou Cancer Hospital
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Jinan, Cina, 250117
- Shandong Cancer Hospital
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Nanjing, Cina, 210009
- Zhongda Hospital Affiliated to Southeast University
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Qingdao, Cina, 266042
- The Affiliated Hospital of Qingdao University
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Shanghai, Cina, 200000
- Shanghai Chest Hospital
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Shantou, Cina, 515041
- Cancer Hospital of Shantou University Medical College
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Taiyuan, Cina, 030013
- Shanxi Provincial Cancer Hospital
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Tianjin, Cina, 300060
- Tianjin Cancer Hospital
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Wenzhou, Cina, 325000
- The 2nd School of Medicine, WMU
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Xiamen, Cina, 361003
- The First Affiliated Hospital of Xiamen University
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Xuzhou, Cina, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Zhengzhou, Cina, 450008
- Henan Cancer Hospital
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Cheongju-si, Corea del Sud, 28644
- Chungbuk National University Hospital
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Daegu, Corea del Sud, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, Corea del Sud, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Corea del Sud, 16247
- St. Vincent's Hospital
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Gyeonggi-do, Corea del Sud, 10408
- National Cancer Center
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Gyeonggi-do, Corea del Sud, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, Corea del Sud, 50612
- Pusan National University Yangsan Hospital
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Incheon, Corea del Sud, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Corea del Sud, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Corea del Sud, 03080
- Seoul National University Hospital
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Seoul, Corea del Sud, 05505
- Asan Medical Center
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Seoul, Corea del Sud, 06351
- Samsung Medical Center
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Seoul, Corea del Sud, 08308
- Korea University Guro Hospital
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Seoul, Corea del Sud, 06591
- Seoul St Mary's Hospital
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Ulsan, Corea del Sud, 44033
- Ulsan University Hosiptal
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Angers, Francia, 49933
- CHU Angers
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Caen, Francia, 14000
- Centre Francois Baclesse
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Marseille, Francia, 13015
- Hopital Nord AP-HM
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Montpellier, Francia, 34070
- Clinique Clémentville
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Vantoux, Francia, 57070
- Hopital Robert Schuman
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Villejuif, Francia, 94805
- Institut Gustave Roussy
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Braunschweig, Germania, 38114
- Klinikum Braunschweig
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Cologne, Germania, 51109
- Klinikum Koeln-Merheim
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Göttingen, Germania, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, Germania, 69126
- Thoraxklinik Heidelberg gGmbH
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München, Germania, 81925
- Klinikum Bogenhausen
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Regensburg, Germania, 93053
- Universitätsklinikum Regensburg
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Aichi, Giappone, 464-8681
- Aichi Cancer Center
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Chiba, Giappone, 277-8577
- National Cancer Center East
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Hyōgo, Giappone, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, Giappone, 252-0375
- Kitasato University Hospital
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Kyoto, Giappone, 606-8507
- Kyoto University Hospital
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Miyagi, Giappone, 981-0914
- Sendai Kousei Hospital
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Niigata, Giappone, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Giappone, 589-8511
- Kindai University Hospital
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Saitama, Giappone, 362-0806
- Saitama Cancer Center
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Shizuoka, Giappone, 411-8777
- Shizuoka Cancer Center
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Tokyo, Giappone, 104-0045
- National Cancer Center Hospital
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Tokyo, Giappone, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, Giappone, 641-8510
- Wakayama Medical University Hospital
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Asvestochóri, Grecia, 570 10
- General Hospital "G.Papanikolaou"
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Athens, Grecia, 11527
- Sotiria Hospital
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Kifissia, Grecia, 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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Beersheba, Israele, 8410100
- Soroka Medical Center
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Haifa, Israele, 3109601
- Rambam Medical Center
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Jerusalem, Israele, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, Israele, 4941492
- Rabin Medical Center
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Campania
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Naples, Campania, Italia, 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, Italia, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Parma, Emilia-Romagna, Italia, 43100
- Azienda Ospedaliero Universitaria di Parma
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Lazio
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Rome, Lazio, Italia, 00128
- Policlinico Universitario Campus Biomedico
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Rome, Lazio, Italia, 00144
- IRCCS Istituto Regina Elena (IFO)
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Liguria
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Genoa, Liguria, Italia, 16132
- IRCCS AOU San Martino - IST
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Lombardy
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Brescia, Lombardy, Italia, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
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Milan, Lombardy, Italia, DUMMY_VALUE
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Pavia, Lombardy, Italia, 27100
- Fondazione IRCCS Policlinico San Matteo
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Tuscany
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Pisa, Tuscany, Italia, 56124
- Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
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Veneto
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Vicenza, Veneto, Italia, 36100
- Azienda ULSS 8 Berica
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Auckland, Nuova Zelanda, 1023
- Auckland City Hospital, Cancer and Blood Research
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Amersfoort, Olanda, 3813 TZ
- Meander Medisch Centrum
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Breda, Olanda, 4819 EV
- Amphia Ziekenhuis
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Leidschendam, Olanda, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
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Sittard-Geleen, Olanda, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
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Gda?sk, Polonia, 80-214
- Uniwersyteckie Centrum Kliniczne
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Olsztyn, Polonia, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
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Otwock, Polonia, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
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Warsaw, Polonia, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
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Wroc?aw, Polonia, 53-413
- Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
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Coimbra, Portogallo, 3000-075
- IPO de Coimbra
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Lisbon, Portogallo, 1500-650
- Hospital da Luz
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Porto, Portogallo, 4100-180
- Hospital CUF Porto
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Porto, Portogallo, 4200-072
- IPO do Porto
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Birmingham, Regno Unito, B9 5SS
- Birmingham Heartlands Hospital
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Cambridge, Regno Unito, CB2 0QQ
- Addenbrooke's NHS Trust
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Glasgow, Regno Unito, G12 0YN
- Beatson West of Scotland Cancer Centre
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Huddersfield, Regno Unito, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
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Leicester, Regno Unito, LE1 5WW
- Leicester Royal Infirmary
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Maidstone, Regno Unito, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
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Manchester, Regno Unito, M20 4BX
- Christie Foundation Trust
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Sheffield, Regno Unito, S10 2SJ
- Weston Park Hospital
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A Coruña, Spagna, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, Spagna, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Spagna, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spagna, 28046
- Hospital Universitario La Paz
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Madrid, Spagna, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, Spagna, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, Spagna, 41013
- Hospital Universitario Virgen del Rocio
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Seville, Spagna, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Spagna, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, Spagna, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, Spagna, 12002
- Hospital Provincial de Castellon
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California
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Palo Alto, California, Stati Uniti, 94305
- Stanford University
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Colorado
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Greeley, Colorado, Stati Uniti, 80631
- Banner MD Anderson Cancer Center
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Florida
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Fort Myers, Florida, Stati Uniti, 33901-8101
- Florida Cancer Specialists
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Palm Bay, Florida, Stati Uniti, 32901
- Cancer Care Centers of Brevard
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Pensacola, Florida, Stati Uniti, 32503
- Woodlands Medical Specialists, P.A.
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St. Petersburg, Florida, Stati Uniti, 33705
- Florida Cancer Specialist, North Region
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Georgia
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Marietta, Georgia, Stati Uniti, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, Stati Uniti, 61615
- Illinois Cancer Care
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Maine
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Brunswick, Maine, Stati Uniti, 04011
- New England Cancer Specialists
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Massachusetts
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Fairhaven, Massachusetts, Stati Uniti, 02719
- Southcoast Health System
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55404
- Minnesota Oncology Hematology
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Missouri
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Kansas City, Missouri, Stati Uniti, 64132
- HCA Midwest Health
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Springfield, Missouri, Stati Uniti, 65807
- Cox Health Systems
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stati Uniti, 89106
- Optum Health Care
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New Jersey
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East Brunswick, New Jersey, Stati Uniti, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
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New Mexico
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Farmington, New Mexico, Stati Uniti, 87401
- San Juan Oncology Associates
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New York
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Albany, New York, Stati Uniti, 12208
- New York Oncology Hematology,P.C.-Albany
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New York, New York, Stati Uniti, 10029
- Mount Sinai Medical Center
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The Bronx, New York, Stati Uniti, 10461
- Montefiore Medical Center
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29615
- Prisma Health ? Upstate
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Tennessee
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Chattanooga, Tennessee, Stati Uniti, 37403
- Tennessee Oncology Chattanooga
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Nashville, Tennessee, Stati Uniti, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Virginia
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Fairfax, Virginia, Stati Uniti, 22031
- Virginia Cancer Specialists
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Norfolk, Virginia, Stati Uniti, 23502
- Virginia Oncology Associates
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Bangkok, Tailandia, 10400
- Rajavithi Hospital
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Bangkok, Tailandia, 10300
- Vajira Hospital
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Bangkok, Tailandia, 10400
- Ramathibodi Hospital;Medicine/Oncology
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Songkhla, Tailandia, 90110
- Songklanagarind Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Adana, Turchia (Türkiye), 01220
- Adana Baskent University Medical Faculty
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Ankara, Turchia (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, Turchia (Türkiye), 06100
- Ankara University Medical Faculty
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Ankara, Turchia (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, Turchia (Türkiye), 35100
- Ege University Medical Faculty
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Diyarbakır, Turchia (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, Turchia (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turchia (Türkiye), 34098
- Istanbul University Cerrahpaşa Faculty of Medicine
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Istanbul, Turchia (Türkiye), 34214
- Medipol University Medical Faculty
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Malatya, Turchia (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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Pécs, Ungheria, 7623
- Pécsi Tudományegyetem
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Tatabánya, Ungheria, 2800
- Szent Borbala Korhaz
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Törökbálint, Ungheria, 2045
- Tudogyogyintezet Torokbalint
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- Performance Status dell'Eastern Cooperative Oncology Group (ECOG) pari a 0 o 1
- NSCLC documentato istologicamente o citologicamente con NSCLC di stadio III localmente avanzato, non resecabile, istologico squamoso o non squamoso
- Tomografia computerizzata a emissione di positroni (PET-TC) di tutto il corpo, eseguita prima ed entro 42 giorni dalla prima dose di chemioradioterapia concomitante (cCRT)
- Almeno due cicli precedenti di chemioterapia a base di platino somministrati in concomitanza con la radioterapia (RT), che devono essere completati entro 1-42 giorni prima della randomizzazione nello studio (un ciclo di cCRT è definito come 21 o 28 giorni)
- La componente di radioterapia (RT) nel cCRT deve essere stata a una dose totale di radiazioni di 60 (±10 percento [%]) gray (Gy) (da 54 Gy a 66 Gy) somministrata mediante RT a intensità modulata (preferita) o 3D- tecnica conforme
- Nessuna progressione durante o dopo una concomitante CRT a base di platino
- Un noto risultato PD-L1
- Aspettativa di vita >/= 12 settimane
- Adeguata funzionalità ematologica e degli organi terminali
- Le partecipanti di sesso femminile devono essere disposte a evitare la gravidanza per 90 giorni dopo la dose finale di tiragolumab e 5 mesi dopo la dose finale di atezolizumab o per 3 mesi dopo la dose finale di durvalumab
- I partecipanti di sesso maschile devono rimanere astinenti o utilizzare un preservativo durante il periodo di trattamento e per 90 giorni dopo la dose finale di tiragolumab
- I partecipanti di sesso maschile non devono donare sperma durante il periodo di trattamento e per 90 giorni dopo la dose finale di tiragolumab
Criteri di esclusione:
- Qualsiasi storia di precedente NSCLC e/o qualsiasi storia di precedente trattamento per NSCLC (i partecipanti devono essere di nuova diagnosi con malattia di stadio III non resecabile)
- NSCLC noto per avere una mutazione nel gene del recettore del fattore di crescita epidermico (EGFR) o un oncogene di fusione della chinasi del linfoma anaplastico (ALK)
- Qualsiasi evidenza di malattia in stadio IV
- Trattamento con CRT sequenziale per NSCLC localmente avanzato
- - Partecipanti con NSCLC localmente avanzato che sono progrediti durante o dopo il cCRT definitivo prima della randomizzazione
- Qualsiasi tossicità irrisolta di grado > 2 da precedente CRT
- Polmonite di grado >= 2 da precedente CRT
- Attivo o storia di malattia autoimmune o immunodeficienza
- Anamnesi di fibrosi polmonare idiopatica, polmonite organizzativa, polmonite indotta da farmaci o polmonite idiopatica o evidenza di polmonite attiva
- Storia di tumori maligni diversi dal NSCLC nei 5 anni precedenti lo screening ad eccezione dei tumori maligni con un rischio trascurabile di metastasi o morte
- Precedente trapianto di cellule staminali allogeniche o di organi solidi
- Infezione da virus di Epstein-Barr attivo (EBV) o infezione da EBV attiva cronica nota o sospetta allo screening
- Trattamento con terapia sperimentale entro 28 giorni prima dell'inizio del trattamento in studio
- Precedente trattamento con agonisti CD137 o terapie di blocco del checkpoint immunitario, tra cui proteina 4 associata ai linfociti T anti-citotossici, immunorecettori anti-cellule T con domini Ig e ITIM (anti-TIGIT), anti-PD-1 e anti-PD-L1
- Qualsiasi precedente evento avverso immuno-mediato di grado >/= 3 o qualsiasi evento avverso immuno-mediato di grado > 1 irrisolto durante la somministrazione di qualsiasi precedente agente immunoterapico diverso dagli agenti di blocco del checkpoint immunitario
- Trattamento con farmaci immunosoppressivi sistemici
- Donne in gravidanza o che allattano
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: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Atezolizumab + Tiragolumab
I partecipanti riceveranno atezolizumab somministrato per via endovenosa (IV) il giorno 1 di ogni ciclo di 28 giorni seguito da tiragolumab somministrato IV il giorno 1 di ogni ciclo di 28 giorni per un massimo di 13 cicli.
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Atezolizumab 1680 mg ogni 4 settimane (Q4W) sarà somministrato IV il giorno 1 di ogni ciclo di 28 giorni.
Altri nomi:
Tiragolumab 840 mg Q4W sarà somministrato IV il giorno 1 di ogni ciclo di 28 giorni.
Altri nomi:
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Comparatore attivo: Durvalumab
I partecipanti riceveranno durvalumab somministrato IV durante ogni ciclo di 28 giorni per un massimo di 13 cicli.
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Durvalumab verrà somministrato in base al peso a 10 mg/kg EV ogni 2 settimane (Q2W) nei giorni 1 e 15 di ogni ciclo di 28 giorni, oppure verrà somministrato a una dose fissa di 1500 mg EV ogni 4 settimane (Q4W) ( per i partecipanti il cui peso >/= 30 kg) il giorno 1 di ogni ciclo di 28 giorni.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Lasso di tempo: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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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.
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From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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PFS, as Assessed by an IRF in FAS
Lasso di tempo: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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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.
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From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Overall Survival (OS) in PPAS
Lasso di tempo: From randomization to death from any cause (up to approximately 57 months)
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OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
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From randomization to death from any cause (up to approximately 57 months)
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PFS, as Assessed by the Investigator in PPAS
Lasso di tempo: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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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.
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From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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Confirmed ORR, as Assessed by the Investigator in PPAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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Duration of Response (DOR), as Assessed by an IRF in PPAS
Lasso di tempo: 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)
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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.
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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)
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DOR, as Assessed by the Investigator in PPAS
Lasso di tempo: 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)
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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.
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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)
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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
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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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
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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OS in FAS
Lasso di tempo: From randomization to death from any cause (up to approximately 57 months)
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OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
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From randomization to death from any cause (up to approximately 57 months)
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PFS, as Assessed by the Investigator in FAS
Lasso di tempo: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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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.
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From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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Confirmed ORR, as Assessed by an IRF in FAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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Confirmed ORR, as Assessed by the Investigator in FAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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DOR, as Assessed by an IRF in FAS
Lasso di tempo: 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)
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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.
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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)
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DOR, as Assessed by the Investigator in FAS
Lasso di tempo: 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)
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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.
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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)
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TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
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PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS
Lasso di tempo: At Months 12, 18, and 24
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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.
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At Months 12, 18, and 24
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PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS
Lasso di tempo: At Months 12, 18, and 24
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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.
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At Months 12, 18, and 24
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OS Rate at 12, 24, 36, and 48 Months in PPAS
Lasso di tempo: At Months 12, 24, 36, and 48
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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.
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At Months 12, 24, 36, and 48
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Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS
Lasso di tempo: Up to approximately 57 months
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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.
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Up to approximately 57 months
|
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PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS
Lasso di tempo: At Months 12, 18, and 24
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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
Lasso di tempo: 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
|
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OS Rate at 12, 24, 36, and 48 Months in FAS
Lasso di tempo: At Months 12, 24, 36, and 48
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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.
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At Months 12, 24, 36, and 48
|
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TTDM, as Assessed by the Investigator in FAS
Lasso di tempo: 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
|
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Number of Participants With Adverse Events (AEs)
Lasso di tempo: Up to approximately 24.7 months
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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.
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Up to approximately 24.7 months
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Number of Participants With Cytokine Release Syndrome (CRS)
Lasso di tempo: 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.
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Up to approximately 24.7 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Clinical Trials, Hoffmann-La Roche
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)
24 agosto 2020
Completamento primario (Effettivo)
27 maggio 2025
Completamento dello studio (Effettivo)
31 luglio 2025
Date di iscrizione allo studio
Primo inviato
13 agosto 2020
Primo inviato che soddisfa i criteri di controllo qualità
13 agosto 2020
Primo Inserito (Effettivo)
14 agosto 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
7 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Malattie delle vie respiratorie
- Malattie polmonari
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Neoplasie polmonari
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Carcinoma, polmone non a piccole cellule
- Agenti antineoplastici, immunologici
- Inibitori del checkpoint immunitario
- Agenti antineoplastici
- Meccanismi molecolari dell'azione farmacologica
- Durvalumab
- atezolizumab
- Tiragolumab
Altri numeri di identificazione dello studio
- GO41854
- 2019-004773-29 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
I ricercatori qualificati possono richiedere l'accesso ai dati dei singoli pazienti attraverso la piattaforma di richiesta dei dati degli studi clinici (www.vivli.org).
Ulteriori dettagli sui criteri di Roche per gli studi ammissibili sono disponibili qui (https://vivli.org/members/ourmembers/). Per ulteriori dettagli sulla politica globale di Roche sulla condivisione delle informazioni cliniche e su come richiedere l'accesso ai documenti relativi agli studi clinici, vedere qui (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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 .
Prove cliniche su Carcinoma polmonare non a piccole cellule (NSCLC)
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Taichung Veterans General HospitalCompletatoCardiotossicità | Carcinoma Polmonare Non a Piccole Cellule (MeSH Term: Carcinoma, Non-Small-Cell Lung) | Effetti Collaterali e Reazioni Avverse Correlati ai Farmaci (Termine MeSH) | Inibitore della Tirosin-chinasi dell'EgfrTaiwan
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National Cancer Institute (NCI)TerminatoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
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Fondazione del Piemonte per l'OncologiaReclutamentoCancro al seno | Cancro ovarico | Cancro del colon-retto | Melanoma (cancro della pelle) | Carcinoma Polmonare Non a Piccole Cellule (MeSH Term: Carcinoma, Non-Small-Cell Lung)Italia
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National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
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National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti
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BeiGeneCompletatoCarcinoma polmonare non a piccole cellule, stadio IV | Carcinoma polmonare non a piccole cellule localmente avanzato, non resecabile o metastatico (NSCLC) | Cancro polmonare nonmall a cell, stadio IIIBFrancia, Cina, Spagna, Australia, Stati Uniti, Grecia, Corea del Sud, Austria
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Genentech, Inc.ReclutamentoMelanoma | Cancro cervicale | HCC | Tumore gastrico | Cancro colorettale | Cancro esofageo | NSCLC | Carcinoma uroteliale | HNSCC | Tumori solidi localmente avanzati o metastatici | TNBC | Clear Cell RCCOlanda, Spagna, Taiwan, Stati Uniti, Australia, Canada, Belgio, Svezia, Grecia, Corea del Sud
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Novartis PharmaceuticalsTerminatoMelanoma | Cancro testa e collo | Tumore del pancreas | Cancro uroteliale | NSCLC, carcinoma polmonare non a piccole cellule | RCC, cancro delle cellule renali | DLBCL, linfoma diffuso a grandi cellule B | MSS, Microsatellite Stable Colon Cancer | TNBC, cancro al seno triplo negativo | mCRPC, carcinoma prostatico...Belgio, Italia, Taiwan, Germania, Spagna, Stati Uniti, Argentina, Australia, Austria, Cechia, Francia, Giappone, Olanda, Svizzera, Singapore
Prove cliniche su Atezolizumab
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University of Geneva, SwitzerlandNon ancora reclutamentoCarcinoma epatocellulare (HCC) | ImmunoterapiaSvizzera
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MediLink Therapeutics (Suzhou) Co., Ltd.Hoffmann-La Roche; Genentech, Inc.ReclutamentoTumori del Torace, Malattie Polmonari, Carcinoma Polmonare a Piccole CelluleStati Uniti, Regno Unito
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Hoffmann-La RocheReclutamentoCarcinoma Polmonare, Carcinoma EpatocellulareSpagna, Belgio, Regno Unito, Italia, Polonia, Austria, Bulgaria, Romania
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Kahr Bio Australia Pty LtdNovotech (Australia) Pty LimitedReclutamentoCancro colorettaleAustralia, Stati Uniti
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University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.Attivo, non reclutanteCancro ai polmoni in stadio IVA AJCC v8 | Cancro al polmone in stadio IVB AJCC v8 | Carcinoma non a piccole cellule del polmone | Cancro al polmone in stadio III AJCC v8 | Cancro al polmone in stadio IV AJCC v8 | Cancro polmonare in stadio II AJCC v8 | Cancro al polmone in stadio IIA AJCC v8 | Cancro... e altre condizioniStati Uniti
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PfizerReclutamentoCarcinoma polmonare a piccole cellule (SCLC)Spagna, Taiwan, Australia, Francia, Giappone, Stati Uniti, Cina, Porto Rico, Italia
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Washington University School of MedicineSumitomo Pharma America, Inc.Non ancora reclutamentoCancro polmonare a piccole cellule | Stadio esteso del carcinoma polmonare a piccole celluleStati Uniti
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Huashan HospitalShanghai Yuansong Biotechnology Co., LTDReclutamento
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MediLink Therapeutics (Suzhou) Co., Ltd.ReclutamentoTumore solido avanzatoStati Uniti, Canada, Francia, Polonia, Spagna, Cina
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Eastern Hepatobiliary Surgery HospitalReclutamentoHCC - Carcinoma epatocellulareCina