En studie av Atezolizumab og Tiragolumab sammenlignet med Durvalumab hos deltakere med lokalt avansert, ikke-opererbar stadium III ikke-småcellet lungekreft (NSCLC) (SKYSCRAPER-03)
7. mai 2026 oppdatert av: Hoffmann-La Roche
En fase III, åpen, randomisert studie av Atezolizumab og Tiragolumab sammenlignet med Durvalumab hos pasienter med lokalt avansert, ikke-opererbar stadium III ikke-småcellet lungekreft som ikke har progrediert etter samtidig platinabasert kjemoradiasjon
Hensikten med denne studien er å evaluere effektiviteten og sikkerheten til atezolizumab i kombinasjon med tirvalumab sammenlignet med durvalumab hos deltakere med lokalt avansert, ikke-opererbar stadium III ikke-småcellet lungekreft (NSCLC) som har fått minst to sykluser med samtidig platina- basert kjemoradioterapi (CRT) og har ikke hatt radiografisk sykdomsprogresjon.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
829
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Buenos Aires, Argentina, C1431FWO
- CEMIC
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Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
- Hospital Británico de Buenos Aires
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Córdoba, Argentina, X5004FHP
- Clínica 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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Charleroi, Belgia, 6000
- GHdC Site Les Viviers
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Ghent, Belgia, 9000
- AZ Maria Middelares
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Hasselt, Belgia, 3500
- Jessa Zkh (Campus Virga Jesse)
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Ceará
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Fortaleza, Ceará, Brasil, 60336-550
- CRIO - Centro Regional Integrado de Oncologia
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Paraná
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Curitiba, Paraná, Brasil, 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, Brasil, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Brasil, 14784-400
- Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, Brasil, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brasil, 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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California
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Palo Alto, California, Forente stater, 94305
- Stanford University
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Colorado
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Greeley, Colorado, Forente stater, 80631
- Banner MD Anderson Cancer Center
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Florida
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Fort Myers, Florida, Forente stater, 33901-8101
- Florida Cancer Specialists
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Palm Bay, Florida, Forente stater, 32901
- Cancer Care Centers of Brevard
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Pensacola, Florida, Forente stater, 32503
- Woodlands Medical Specialists, P.A.
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St. Petersburg, Florida, Forente stater, 33705
- Florida Cancer Specialist, North Region
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Georgia
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Marietta, Georgia, Forente stater, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, Forente stater, 61615
- Illinois Cancer Care
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Maine
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Brunswick, Maine, Forente stater, 04011
- New England Cancer Specialists
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Massachusetts
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Fairhaven, Massachusetts, Forente stater, 02719
- Southcoast Health System
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55404
- Minnesota Oncology Hematology
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Missouri
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Kansas City, Missouri, Forente stater, 64132
- HCA Midwest Health
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Springfield, Missouri, Forente stater, 65807
- Cox Health Systems
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Nevada
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Las Vegas, Nevada, Forente stater, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Forente stater, 89106
- Optum Health Care
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New Jersey
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East Brunswick, New Jersey, Forente stater, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
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New Mexico
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Farmington, New Mexico, Forente stater, 87401
- San Juan Oncology Associates
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New York
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Albany, New York, Forente stater, 12208
- New York Oncology Hematology,P.C.-Albany
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center
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The Bronx, New York, Forente stater, 10461
- Montefiore Medical Center
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South Carolina
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Greenville, South Carolina, Forente stater, 29615
- Prisma Health ? Upstate
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37403
- Tennessee Oncology Chattanooga
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Nashville, Tennessee, Forente stater, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Virginia
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Fairfax, Virginia, Forente stater, 22031
- Virginia Cancer Specialists
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Norfolk, Virginia, Forente stater, 23502
- Virginia Oncology Associates
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Angers, Frankrike, 49933
- CHU Angers
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Caen, Frankrike, 14000
- Centre François Baclesse
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Marseille, Frankrike, 13015
- Hopital Nord AP-HM
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Montpellier, Frankrike, 34070
- Clinique Clementville
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Vantoux, Frankrike, 57070
- Hôpital Robert Schuman
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Villejuif, Frankrike, 94805
- Institut Gustave Roussy
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Asvestochóri, Hellas, 570 10
- General Hospital "G.Papanikolaou"
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Athens, Hellas, 11527
- Sotiria Hospital
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Kifissia, Hellas, 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, Israel, 8410100
- Soroka Medical Center
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Haifa, Israel, 3109601
- Rambam Medical Center
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Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, Israel, 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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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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Beijing, Kina, 101149
- Beijing Chest Hospital
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Beijing, Kina, 100142
- Beijing Cancer Center
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Changchun, Kina, 132013
- Jilin cancer hospital
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Changsha, Kina, 410008
- Xiangya Hospital Central South University
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Chengdu, Kina, 610041
- Sichuan Provincial Cancer Hospital
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Chongqing, Kina, 400030
- Chongqing Cancer Hospital
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Fujian, Kina, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Kina, 350014
- Fujian Provincial Cancer Hospital
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Guangzhou, Kina, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, Kina, 310002
- Hangzhou Cancer Hospital
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Jinan, Kina, 250117
- Shandong Cancer Hospital
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Nanjing, Kina, 210009
- Zhongda Hospital Affiliated to Southeast University
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Qingdao, Kina, 266042
- The Affiliated Hospital of Qingdao University
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Shanghai, Kina, 200000
- Shanghai Chest Hospital
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Shantou, Kina, 515041
- Cancer Hospital of Shantou University Medical College
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Taiyuan, Kina, 030013
- Shanxi Provincial Cancer Hospital
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Tianjin, Kina, 300060
- Tianjin Cancer Hospital
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Wenzhou, Kina, 325000
- The 2nd School of Medicine, WMU
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Xiamen, Kina, 361003
- The First Affiliated Hospital of Xiamen University
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Xuzhou, Kina, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Zhengzhou, Kina, 450008
- Henan Cancer 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, New Zealand, 1023
- Auckland City Hospital, Cancer and Blood Research
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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, Spania, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, Spania, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Spania, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spania, 28046
- Hospital Universitario La Paz
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Madrid, Spania, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, Spania, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, Spania, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Spania, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Spania, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, Spania, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, Spania, 12002
- Hospital Provincial de Castellon
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Birmingham, Storbritannia, B9 5SS
- Birmingham Heartlands Hospital
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Cambridge, Storbritannia, CB2 0QQ
- Addenbrooke's NHS Trust
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Glasgow, Storbritannia, G12 0YN
- Beatson West of Scotland Cancer Centre
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Huddersfield, Storbritannia, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
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Leicester, Storbritannia, LE1 5WW
- Leicester Royal Infirmary
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Maidstone, Storbritannia, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
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Manchester, Storbritannia, M20 4BX
- Christie Foundation Trust
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Sheffield, Storbritannia, S10 2SJ
- Weston Park Hospital
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Cheongju-si, Sør -Korea, 28644
- Chungbuk National University Hospital
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Daegu, Sør -Korea, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, Sør -Korea, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Sør -Korea, 16247
- St. Vincent's Hospital
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Gyeonggi-do, Sør -Korea, 10408
- National Cancer Center
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Gyeonggi-do, Sør -Korea, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, Sør -Korea, 50612
- Pusan National University Yangsan Hospital
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Incheon, Sør -Korea, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Sør -Korea, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital
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Seoul, Sør -Korea, 05505
- Asan Medical Center
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Seoul, Sør -Korea, 06351
- Samsung Medical Center
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Seoul, Sør -Korea, 08308
- Korea University Guro Hospital
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Seoul, Sør -Korea, 06591
- Seoul St Mary's Hospital
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Ulsan, Sør -Korea, 44033
- Ulsan University Hosiptal
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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, Tyrkia (Türkiye), 01220
- Adana Baskent University Medical Faculty
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Ankara, Tyrkia (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, Tyrkia (Türkiye), 06100
- Ankara University Medical Faculty
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Ankara, Tyrkia (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, Tyrkia (Türkiye), 35100
- Ege University Medical Faculty
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Diyarbakır, Tyrkia (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, Tyrkia (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Tyrkia (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Tyrkia (Türkiye), 34214
- Medipol University Medical Faculty
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Malatya, Tyrkia (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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Braunschweig, Tyskland, 38114
- Klinikum Braunschweig
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Cologne, Tyskland, 51109
- Klinikum Koeln-Merheim
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Göttingen, Tyskland, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, Tyskland, 69126
- Thoraxklinik Heidelberg gGmbH
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München, Tyskland, 81925
- Klinikum Bogenhausen
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Regensburg, Tyskland, 93053
- Universitätsklinikum Regensburg
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Pécs, Ungarn, 7623
- Pecsi Tudomanyegyetem
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Tatabánya, Ungarn, 2800
- Szent Borbala Korhaz
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Törökbálint, Ungarn, 2045
- Tudogyogyintezet Torokbalint
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Innsbruck, Østerrike, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, Østerrike, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, Østerrike, 1140
- Klinik Penzing
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Eastern Cooperative Oncology Group (ECOG) ytelsesstatus på 0 eller 1
- Histologisk eller cytologisk dokumentert NSCLC med lokalt avansert, ikke-opererbar stadium III NSCLC av enten plateepitel- eller ikke-plateepitelhistologi
- Helkropps positronemisjonstomografi-computertomografi (PET-CT) skanning, utført før og innen 42 dager etter den første dosen med samtidig kjemoradioterapi (cCRT)
- Minst to tidligere sykluser med platinabasert kjemoterapi administrert samtidig med strålebehandling (RT), som må fullføres innen 1 til 42 dager før randomisering i studien (én syklus med cCRT er definert som 21 eller 28 dager)
- Stråleterapikomponenten (RT) i cCRT må ha vært i en total strålingsdose på 60 (±10 prosent [%)) grå (Gy) (54 Gy til 66 Gy) administrert av intensitetsmodulert RT (foretrukket) eller 3D- konform teknikk
- Ingen progresjon under eller etter samtidig platinabasert CRT
- Et kjent PD-L1-resultat
- Forventet levealder >/= 12 uker
- Tilstrekkelig hematologisk og endeorganfunksjon
- Kvinnelige deltakere må være villige til å unngå graviditet i 90 dager etter siste dose av tirvalumab og 5 måneder etter siste dose atezolizumab, eller i 3 måneder etter siste dose av durvalumab.
- Mannlige deltakere må forbli avholdende eller bruke kondom under behandlingsperioden og i 90 dager etter den siste dosen av tiragolumab
- Mannlige deltakere må ikke donere sæd i løpet av behandlingsperioden og i 90 dager etter siste dose av tiragolumab
Ekskluderingskriterier:
- Enhver historie med tidligere NSCLC og/eller tidligere behandling for NSCLC (deltakere må nylig diagnostiseres med ikke-opererbar stadium III sykdom)
- NSCLC kjent for å ha en mutasjon i genet for epidermal vekstfaktorreseptor (EGFR) eller et anaplastisk lymfomkinase (ALK) fusjonsonkogen
- Eventuelle tegn på Stage IV sykdom
- Behandling med sekvensiell CRT for lokalt avansert NSCLC
- Deltakere med lokalt avansert NSCLC som har utviklet seg under eller etter den definitive cCRT før randomisering
- Enhver grad >2 uløst toksisitet fra tidligere CRT
- Grad >= 2 pneumonitt fra tidligere CRT
- Aktiv eller historie med autoimmun sykdom eller immunsvikt
- Anamnese med idiopatisk lungefibrose, organiserende lungebetennelse, medikamentindusert lungebetennelse eller idiopatisk lungebetennelse eller tegn på aktiv pneumonitt
- Andre maligniteter enn NSCLC innen 5 år før screening med unntak av maligniteter med en ubetydelig risiko for metastaser eller død
- Tidligere allogen stamcelle- eller fastorgantransplantasjon
- Aktiv Epstein-Barr virus (EBV) infeksjon eller kjent eller mistenkt kronisk aktiv EBV infeksjon ved screening
- Behandling med forsøksbehandling innen 28 dager før oppstart av studiebehandling
- Tidligere behandling med CD137-agonister eller immunsjekkpunktblokkadeterapier, inkludert anti-cytotoksisk T-lymfocyttassosiert protein 4, anti-T-celle immunreseptor med Ig- og ITIM-domener (anti-TIGIT), anti-PD-1 og anti-PD-L1
- Enhver tidligere grad >/= 3 immun-mediert bivirkning eller enhver uløst grad > 1 immun-mediert bivirkning mens du har mottatt et tidligere immunterapimiddel annet enn immunkontrollpunktblokkademidler
- Behandling med systemisk immunsuppressiv medisin
- Kvinner som er gravide eller ammer
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Atezolizumab + Tiragolumab
Deltakerne vil få atezolizumab administrert intravenøst (IV) på dag 1 i hver 28-dagers syklus etterfulgt av tiragolumab administrert IV på dag 1 av hver 28-dagers syklus i maksimalt 13 sykluser.
|
Atezolizumab 1680 mg hver 4. uke (Q4W) vil bli administrert IV på dag 1 av hver 28-dagers syklus.
Andre navn:
Tiragolumab 840 mg Q4W vil bli administrert IV på dag 1 av hver 28-dagers syklus.
Andre navn:
|
|
Aktiv komparator: Durvalumab
Deltakerne vil få durvalumab administrert IV i løpet av hver 28-dagers syklus i maksimalt 13 sykluser.
|
Durvalumab vil bli administrert basert på vekt ved 10 mg/kg IV hver 2. uke (Q2W) på dag 1 og 15 i hver 28-dagers syklus, eller vil bli administrert med en fast dose på 1500 mg IV hver 4. uke (Q4W) ( for deltakere med vekt >/= 30 kg) på dag 1 i hver 28-dagers syklus.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Tidsramme: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions.
Kaplan-Meier (K-M) method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
PFS, as Assessed by an IRF in FAS
Tidsramme: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS) in PPAS
Tidsramme: From randomization to death from any cause (up to approximately 57 months)
|
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
|
From randomization to death from any cause (up to approximately 57 months)
|
|
PFS, as Assessed by the Investigator in PPAS
Tidsramme: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS
Tidsramme: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesion & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Confirmed ORR, as Assessed by the Investigator in PPAS
Tidsramme: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Duration of Response (DOR), as Assessed by an IRF in PPAS
Tidsramme: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
DOR, as Assessed by the Investigator in PPAS
Tidsramme: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Time to Confirmed Deterioration (TTCD) in Cough, as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) in PPAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first confirmed clinically meaningful deterioration (CCMD) on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Cough scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Global Health Status (GHS)/Quality-of-life (QoL), as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Core-30 (EORTC QLQ-C30) in PPAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent.
Scores were linearly transformed to a score range of 0-100.
High score for GHS/QoL scale=better health-related quality-of-life (HRQoL).
CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments/initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to a score range of 0-100.
High score for PF=high/healthy level of functioning.
CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
OS in FAS
Tidsramme: From randomization to death from any cause (up to approximately 57 months)
|
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
|
From randomization to death from any cause (up to approximately 57 months)
|
|
PFS, as Assessed by the Investigator in FAS
Tidsramme: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Confirmed ORR, as Assessed by an IRF in FAS
Tidsramme: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Confirmed ORR, as Assessed by the Investigator in FAS
Tidsramme: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
DOR, as Assessed by an IRF in FAS
Tidsramme: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
DOR, as Assessed by the Investigator in FAS
Tidsramme: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Cough was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent.
Scores were linearly transformed to a score range of 0-100.
High score for GHS/QoL scale=better HRQoL.
CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS
Tidsramme: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to a score range of 0-100.
High score for PF=high/healthy level of functioning.
CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS
Tidsramme: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS
Tidsramme: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
OS Rate at 12, 24, 36, and 48 Months in PPAS
Tidsramme: At Months 12, 24, 36, and 48
|
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints.
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate OS rate.
Percentages have been rounded off.
|
At Months 12, 24, 36, and 48
|
|
Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS
Tidsramme: Up to approximately 57 months
|
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first.
Distant metastasis was defined as any new lesion that was outside of the radiation field.
K-M method was used to estimate median TTDM.
|
Up to approximately 57 months
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS
Tidsramme: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in FAS
Tidsramme: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
OS Rate at 12, 24, 36, and 48 Months in FAS
Tidsramme: At Months 12, 24, 36, and 48
|
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints.
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate OS rate.
Percentages have been rounded off.
|
At Months 12, 24, 36, and 48
|
|
TTDM, as Assessed by the Investigator in FAS
Tidsramme: Up to approximately 57 months
|
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first.
Distant metastasis was defined as any new lesion that was outside of the radiation field.
K-M method was used to estimate median TTDM.
|
Up to approximately 57 months
|
|
Number of Participants With Adverse Events (AEs)
Tidsramme: Up to approximately 24.7 months
|
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.
|
Up to approximately 24.7 months
|
|
Number of Participants With Cytokine Release Syndrome (CRS)
Tidsramme: Up to approximately 24.7 months
|
CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells.
Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction.
|
Up to approximately 24.7 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Trials, Hoffmann-La Roche
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
24. august 2020
Primær fullføring (Faktiske)
27. mai 2025
Studiet fullført (Faktiske)
31. juli 2025
Datoer for studieregistrering
Først innsendt
13. august 2020
Først innsendt som oppfylte QC-kriteriene
13. august 2020
Først lagt ut (Faktiske)
14. august 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Lungesykdommer
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Lungeneoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Karsinom, ikke-småcellet lunge
- Antineoplastiske midler, immunologiske
- Immune Checkpoint-hemmere
- Antineoplastiske midler
- Molekylære mekanismer for farmakologisk virkning
- Durvalumab
- Atezolizumab
- Tiragolumab
Andre studie-ID-numre
- GO41854
- 2019-004773-29 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Kvalifiserte forskere kan be om tilgang til individuelle pasientnivådata gjennom plattformen for forespørsel om kliniske studiedata (www.vivli.org).
Ytterligere detaljer om Roches kriterier for kvalifiserte studier er tilgjengelig her (https://vivli.org/members/ourmembers/). For ytterligere detaljer om Roches globale retningslinjer for deling av klinisk informasjon og hvordan du ber om tilgang til relaterte kliniske studiedokumenter, se her (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .