Een studie van atezolizumab en tiragolumab vergeleken met durvalumab bij deelnemers met lokaal gevorderde, inoperabele stadium III niet-kleincellige longkanker (NSCLC) (SKYSCRAPER-03)
7 mei 2026 bijgewerkt door: Hoffmann-La Roche
Een open-label, gerandomiseerde fase III-studie van atezolizumab en tiragolumab vergeleken met durvalumab bij patiënten met lokaal gevorderde, inoperabele stadium III niet-kleincellige longkanker die geen progressie hebben vertoond na gelijktijdige op platina gebaseerde chemoradiatie
Het doel van deze studie is het evalueren van de werkzaamheid en veiligheid van atezolizumab in combinatie met tiragolumab in vergelijking met durvalumab bij deelnemers met lokaal gevorderde, inoperabele stadium III niet-kleincellige longkanker (NSCLC) die ten minste twee gelijktijdige platinacycli hebben gekregen. gebaseerde chemoradiotherapie (CRT) en geen radiografische ziekteprogressie hebben gehad.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
829
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Buenos Aires, Argentinië, C1431FWO
- CEMIC
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Ciudad Autonoma Buenos Aires, Argentinië, C1284AEB
- Hospital Británico de Buenos Aires
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Córdoba, Argentinië, X5004FHP
- Clínica Universitaria Reina Fabiola
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Rosario, Argentinië, S2000QGB
- Sanatorio Parque S.A.
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New South Wales
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Blacktown, New South Wales, Australië, 2148
- Blacktown Hospital
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Campbelltown, New South Wales, Australië, 2560
- Macarthur Cancer Therapy Centre
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Kogarah, New South Wales, Australië, 2217
- St George Hospital
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South Australia
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Bedford Park, South Australia, Australië, 5042
- Flinders Medical Centre
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Victoria
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Victoria, Victoria, Australië, 3168
- Monash Health Translational Precinct
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Western Australia
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Bull Creek, Western Australia, Australië, 6149
- Fiona Stanley Hospital
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Charleroi, België, 6000
- GHdC Site Les Viviers
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Ghent, België, 9000
- AZ Maria Middelares
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Hasselt, België, 3500
- Jessa Zkh (Campus Virga Jesse)
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Ceará
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Fortaleza, Ceará, Brazilië, 60336-550
- CRIO - Centro Regional Integrado de Oncologia
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Paraná
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Curitiba, Paraná, Brazilië, 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, Brazilië, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Brazilië, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Brazilië, 14784-400
- Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, Brazilië, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brazilië, 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, China, 101149
- Beijing Chest Hospital
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Beijing, China, 100142
- Beijing Cancer Center
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Changchun, China, 132013
- Jilin cancer hospital
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Changsha, China, 410008
- Xiangya Hospital Central South University
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Chengdu, China, 610041
- Sichuan Provincial Cancer Hospital
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Chongqing, China, 400030
- Chongqing Cancer Hospital
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Fujian, China, 350001
- Fujian Medical University Union Hospital
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Fuzhou, China, 350014
- Fujian Provincial Cancer Hospital
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Guangzhou, China, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, China, 310002
- Hangzhou Cancer Hospital
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Jinan, China, 250117
- Shandong Cancer Hospital
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Nanjing, China, 210009
- Zhongda Hospital Affiliated to Southeast University
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Qingdao, China, 266042
- The Affiliated Hospital of Qingdao University
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Shanghai, China, 200000
- Shanghai Chest Hospital
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Shantou, China, 515041
- Cancer Hospital of Shantou University Medical College
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Taiyuan, China, 030013
- Shanxi Provincial Cancer Hospital
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Tianjin, China, 300060
- Tianjin Cancer Hospital
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Wenzhou, China, 325000
- The 2nd School of Medicine, WMU
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Xiamen, China, 361003
- The First Affiliated Hospital of Xiamen University
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Xuzhou, China, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Zhengzhou, China, 450008
- Henan Cancer Hospital
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Braunschweig, Duitsland, 38114
- Klinikum Braunschweig
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Cologne, Duitsland, 51109
- Klinikum Koeln-Merheim
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Göttingen, Duitsland, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, Duitsland, 69126
- Thoraxklinik Heidelberg gGmbH
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München, Duitsland, 81925
- Klinikum Bogenhausen
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Regensburg, Duitsland, 93053
- Universitätsklinikum Regensburg
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Angers, Frankrijk, 49933
- CHU Angers
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Caen, Frankrijk, 14000
- Centre François Baclesse
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Marseille, Frankrijk, 13015
- Hopital Nord AP-HM
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Montpellier, Frankrijk, 34070
- Clinique Clementville
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Vantoux, Frankrijk, 57070
- Hôpital Robert Schuman
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Villejuif, Frankrijk, 94805
- Institut Gustave Roussy
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Asvestochóri, Griekenland, 570 10
- General Hospital "G.Papanikolaou"
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Athens, Griekenland, 11527
- Sotiria Hospital
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Kifissia, Griekenland, 145 64
- Agioi Anargyroi Cancer Hospital
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Pécs, Hongarije, 7623
- Pecsi Tudomanyegyetem
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Tatabánya, Hongarije, 2800
- Szent Borbala Korhaz
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Törökbálint, Hongarije, 2045
- Tudogyogyintezet Torokbalint
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Hong Kong, Hongkong
- Tuen Mun Hospital
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Hong Kong, Hongkong
- Pamela Youde Nethersole Eastern Hospital
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Hong Kong, Hongkong, DUMMY_VALUE
- Queen Elizabeth Hospital
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Hong Kong, Hongkong, DUMMY_VALUE
- Princess Margaret Hospital, Oncology
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Pokfulam, Hongkong, DUMMY_VALUE
- Queen Mary Hospital
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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, Italië, 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, Italië, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Parma, Emilia-Romagna, Italië, 43100
- Azienda Ospedaliero Universitaria di Parma
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Lazio
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Rome, Lazio, Italië, 00128
- Policlinico Universitario Campus Biomedico
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Rome, Lazio, Italië, 00144
- IRCCS Istituto Regina Elena (IFO)
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Liguria
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Genoa, Liguria, Italië, 16132
- IRCCS AOU San Martino - IST
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Lombardy
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Brescia, Lombardy, Italië, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
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Milan, Lombardy, Italië, DUMMY_VALUE
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Pavia, Lombardy, Italië, 27100
- Fondazione IRCCS Policlinico San Matteo
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Tuscany
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Pisa, Tuscany, Italië, 56124
- Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
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Veneto
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Vicenza, Veneto, Italië, 36100
- Azienda ULSS 8 Berica
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Aichi, Japan, 464-8681
- Aichi Cancer Center
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Chiba, Japan, 277-8577
- National Cancer Center East
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Hyōgo, Japan, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, Japan, 252-0375
- Kitasato University Hospital
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Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Miyagi, Japan, 981-0914
- Sendai Kousei Hospital
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japan, 589-8511
- Kindai University Hospital
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Saitama, Japan, 362-0806
- Saitama Cancer Center
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Shizuoka, Japan, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japan, 104-0045
- National Cancer Center Hospital
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Tokyo, Japan, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, Japan, 641-8510
- Wakayama Medical University Hospital
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Amersfoort, Nederland, 3813 TZ
- Meander Medisch Centrum
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Breda, Nederland, 4819 EV
- Amphia Ziekenhuis
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Leidschendam, Nederland, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
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Sittard-Geleen, Nederland, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
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Auckland, Nieuw-Zeeland, 1023
- Auckland City Hospital, Cancer and Blood Research
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Innsbruck, Oostenrijk, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, Oostenrijk, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, Oostenrijk, 1140
- Klinik Penzing
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Gda?sk, Polen, 80-214
- Uniwersyteckie Centrum Kliniczne
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Olsztyn, Polen, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
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Otwock, Polen, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Warsaw, Polen, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
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Wroc?aw, Polen, 53-413
- Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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Coimbra, Portugal, 3000-075
- IPO de Coimbra
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Lisbon, Portugal, 1500-650
- Hospital da Luz
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Porto, Portugal, 4100-180
- Hospital CUF Porto
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Porto, Portugal, 4200-072
- IPO do Porto
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A Coruña, Spanje, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, Spanje, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Spanje, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spanje, 28046
- Hospital Universitario La Paz
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Madrid, Spanje, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, Spanje, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, Spanje, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Spanje, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Spanje, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, Spanje, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, Spanje, 12002
- Hospital Provincial de Castellon
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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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Bangkok, Thailand, 10400
- Rajavithi Hospital
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Bangkok, Thailand, 10300
- Vajira Hospital
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Bangkok, Thailand, 10400
- Ramathibodi Hospital;Medicine/Oncology
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Songkhla, Thailand, 90110
- Songklanagarind Hospital
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Adana, Turkije (Türkiye), 01220
- Adana Baskent University Medical Faculty
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Ankara, Turkije (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, Turkije (Türkiye), 06100
- Ankara University Medical Faculty
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Ankara, Turkije (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, Turkije (Türkiye), 35100
- Ege University Medical Faculty
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Diyarbakır, Turkije (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, Turkije (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turkije (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Turkije (Türkiye), 34214
- Medipol University Medical Faculty
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Malatya, Turkije (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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Birmingham, Verenigd Koninkrijk, B9 5SS
- Birmingham Heartlands Hospital
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Cambridge, Verenigd Koninkrijk, CB2 0QQ
- Addenbrooke's NHS Trust
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Glasgow, Verenigd Koninkrijk, G12 0YN
- Beatson West of Scotland Cancer Centre
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Huddersfield, Verenigd Koninkrijk, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
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Leicester, Verenigd Koninkrijk, LE1 5WW
- Leicester Royal Infirmary
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Maidstone, Verenigd Koninkrijk, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
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Manchester, Verenigd Koninkrijk, M20 4BX
- Christie Foundation Trust
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Sheffield, Verenigd Koninkrijk, S10 2SJ
- Weston Park Hospital
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California
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Palo Alto, California, Verenigde Staten, 94305
- Stanford University
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Colorado
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Greeley, Colorado, Verenigde Staten, 80631
- Banner MD Anderson Cancer Center
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Florida
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Fort Myers, Florida, Verenigde Staten, 33901-8101
- Florida Cancer Specialists
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Palm Bay, Florida, Verenigde Staten, 32901
- Cancer Care Centers of Brevard
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Pensacola, Florida, Verenigde Staten, 32503
- Woodlands Medical Specialists, P.A.
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St. Petersburg, Florida, Verenigde Staten, 33705
- Florida Cancer Specialist, North Region
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Georgia
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Marietta, Georgia, Verenigde Staten, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, Verenigde Staten, 61615
- Illinois Cancer Care
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Maine
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Brunswick, Maine, Verenigde Staten, 04011
- New England Cancer Specialists
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Massachusetts
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Fairhaven, Massachusetts, Verenigde Staten, 02719
- Southcoast Health System
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55404
- Minnesota Oncology Hematology
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64132
- HCA Midwest Health
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Springfield, Missouri, Verenigde Staten, 65807
- Cox Health Systems
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Verenigde Staten, 89106
- Optum Health Care
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New Jersey
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East Brunswick, New Jersey, Verenigde Staten, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
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New Mexico
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Farmington, New Mexico, Verenigde Staten, 87401
- San Juan Oncology Associates
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New York
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Albany, New York, Verenigde Staten, 12208
- New York Oncology Hematology,P.C.-Albany
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New York, New York, Verenigde Staten, 10029
- Mount Sinai Medical Center
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The Bronx, New York, Verenigde Staten, 10461
- Montefiore Medical Center
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29615
- Prisma Health ? Upstate
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Tennessee
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Chattanooga, Tennessee, Verenigde Staten, 37403
- Tennessee Oncology Chattanooga
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Nashville, Tennessee, Verenigde Staten, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Virginia
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Fairfax, Virginia, Verenigde Staten, 22031
- Virginia Cancer Specialists
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Norfolk, Virginia, Verenigde Staten, 23502
- Virginia Oncology Associates
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Cheongju-si, Zuid -Korea, 28644
- Chungbuk National University Hospital
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Daegu, Zuid -Korea, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, Zuid -Korea, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Zuid -Korea, 16247
- St. Vincent's Hospital
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Gyeonggi-do, Zuid -Korea, 10408
- National Cancer Center
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Gyeonggi-do, Zuid -Korea, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, Zuid -Korea, 50612
- Pusan National University Yangsan Hospital
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Incheon, Zuid -Korea, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Zuid -Korea, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Zuid -Korea, 03080
- Seoul National University Hospital
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Seoul, Zuid -Korea, 05505
- Asan Medical Center
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Seoul, Zuid -Korea, 06351
- Samsung Medical Center
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Seoul, Zuid -Korea, 08308
- Korea University Guro Hospital
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Seoul, Zuid -Korea, 06591
- Seoul St Mary's Hospital
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Ulsan, Zuid -Korea, 44033
- Ulsan University Hosiptal
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
- Eastern Cooperative Oncology Group (ECOG) Prestatiestatus van 0 of 1
- Histologisch of cytologisch gedocumenteerd NSCLC met lokaal gevorderd, inoperabel stadium III NSCLC van squameuze of niet-squameuze histologie
- Positronemissietomografie-computertomografie (PET-CT)-scan van het hele lichaam, uitgevoerd vóór en binnen 42 dagen na de eerste dosis gelijktijdige chemoradiotherapie (cCRT)
- Ten minste twee eerdere cycli van op platina gebaseerde chemotherapie gelijktijdig toegediend met radiotherapie (RT), die binnen 1 tot 42 dagen voorafgaand aan randomisatie in het onderzoek moeten zijn voltooid (één cyclus van cCRT wordt gedefinieerd als 21 of 28 dagen)
- De radiotherapie (RT)-component in de cCRT moet een totale stralingsdosis van 60 (±10 procent [%]) grijs (Gy) (54 Gy tot 66 Gy) hebben gehad, toegediend door intensiteitsgemoduleerde RT (bij voorkeur) of 3D- conformerende techniek
- Geen progressie tijdens of na gelijktijdige op platina gebaseerde CRT
- Een bekend PD-L1 resultaat
- Levensverwachting >/= 12 weken
- Adequate hematologische en eindorgaanfunctie
- Vrouwelijke deelnemers moeten bereid zijn zwangerschap te vermijden gedurende 90 dagen na de laatste dosis tiragolumab en 5 maanden na de laatste dosis atezolizumab, of gedurende 3 maanden na de laatste dosis durvalumab
- Mannelijke deelnemers moeten onthouding blijven of een condoom gebruiken tijdens de behandelingsperiode en gedurende 90 dagen na de laatste dosis tiragolumab
- Mannelijke deelnemers mogen geen sperma doneren tijdens de behandelingsperiode en gedurende 90 dagen na de laatste dosis tiragolumab
Uitsluitingscriteria:
- Elke voorgeschiedenis van eerdere NSCLC en/of elke voorgeschiedenis van eerdere behandeling voor NSCLC (deelnemers moeten nieuw gediagnosticeerd zijn met inoperabele fase III-ziekte)
- NSCLC waarvan bekend is dat het een mutatie heeft in het epidermale groeifactorreceptor (EGFR)-gen of een anaplastisch lymfoomkinase (ALK)-fusie-oncogen
- Enig bewijs van stadium IV-ziekte
- Behandeling met sequentiële CRT voor lokaal gevorderde NSCLC
- Deelnemers met lokaal gevorderde NSCLC die gevorderd zijn tijdens of na de definitieve cCRT voorafgaand aan randomisatie
- Elke graad >2 onopgeloste toxiciteit van eerdere CRT
- Graad >= 2 pneumonitis door eerdere CRT
- Actieve of voorgeschiedenis van auto-immuunziekte of immuundeficiëntie
- Geschiedenis van idiopathische longfibrose, organiserende pneumonie, door geneesmiddelen veroorzaakte pneumonitis of idiopathische pneumonitis of bewijs van actieve pneumonitis
- Geschiedenis van andere maligniteiten dan NSCLC binnen 5 jaar voorafgaand aan screening, met uitzondering van maligniteiten met een verwaarloosbaar risico op metastase of overlijden
- Eerdere allogene stamcel- of solide orgaantransplantatie
- Actieve infectie met Epstein-Barr-virus (EBV) of bekende of vermoede chronische actieve EBV-infectie bij screening
- Behandeling met onderzoekstherapie binnen 28 dagen voorafgaand aan de start van de studiebehandeling
- Voorafgaande behandeling met CD137-agonisten of immuuncheckpoint-blokkadetherapieën, waaronder anti-cytotoxisch T-lymfocyt-geassocieerd eiwit 4, anti-T-cel-immunoreceptor met Ig- en ITIM-domeinen (anti-TIGIT), anti-PD-1 en anti-PD-L1
- Elke eerdere graad >/= 3 immuungemedieerde bijwerking of elke onopgeloste graad > 1 immuungemedieerde bijwerking tijdens het ontvangen van een eerder immunotherapiemiddel anders dan immuuncheckpointblokkademiddelen
- Behandeling met systemische immunosuppressiva
- Vrouwen die zwanger zijn of borstvoeding geven
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Atezolizumab + Tiragolumab
Deelnemers krijgen atezolizumab intraveneus (IV) toegediend op dag 1 van elke cyclus van 28 dagen, gevolgd door tiragolumab IV toegediend op dag 1 van elke cyclus van 28 dagen gedurende maximaal 13 cycli.
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Atezolizumab 1680 mg elke 4 weken (Q4W) wordt i.v. toegediend op dag 1 van elke cyclus van 28 dagen.
Andere namen:
Tiragolumab 840 mg Q4W wordt i.v. toegediend op dag 1 van elke cyclus van 28 dagen.
Andere namen:
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Actieve vergelijker: Durvalumab
Deelnemers krijgen durvalumab intraveneus toegediend tijdens elke cyclus van 28 dagen gedurende maximaal 13 cycli.
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Durvalumab zal worden toegediend op basis van gewicht bij 10 mg/kg IV elke 2 weken (Q2W) op dag 1 en 15 van elke cyclus van 28 dagen, of zal worden toegediend in een vaste dosis van 1500 mg IV elke 4 weken (Q4W) ( voor deelnemers met een gewicht >/= 30 kg) op dag 1 van elke cyclus van 28 dagen.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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)
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Overall Survival (OS) in PPAS
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
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TTDM, as Assessed by the Investigator in FAS
Tijdsspanne: 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)
Tijdsspanne: 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.
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Up to approximately 24.7 months
|
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Number of Participants With Cytokine Release Syndrome (CRS)
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Clinical Trials, Hoffmann-La Roche
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
24 augustus 2020
Primaire voltooiing (Werkelijk)
27 mei 2025
Studie voltooiing (Werkelijk)
31 juli 2025
Studieregistratiedata
Eerst ingediend
13 augustus 2020
Eerst ingediend dat voldeed aan de QC-criteria
13 augustus 2020
Eerst geplaatst (Werkelijk)
14 augustus 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
7 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Ziekten van de luchtwegen
- Longziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Longneoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Carcinoom, niet-kleincellige long
- Antineoplastische middelen, immunologisch
- Immuun Checkpoint-remmers
- Antineoplastische middelen
- Moleculaire mechanismen van farmacologische werking
- durvalumab
- atezolizumab
- Tiragolumab
Andere studie-ID-nummers
- GO41854
- 2019-004773-29 (EudraCT-nummer)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Gekwalificeerde onderzoekers kunnen toegang vragen tot gegevens op individueel patiëntniveau via het platform voor het aanvragen van klinische onderzoeksgegevens (www.vivli.org).
Meer details over de criteria van Roche voor in aanmerking komende studies zijn hier beschikbaar (https://vivli.org/members/ourmembers/). Zie hier (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm) voor meer informatie over het wereldwijde beleid van Roche inzake het delen van klinische informatie en hoe u toegang kunt krijgen tot verwante klinische onderzoeksdocumenten.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .