Um estudo de atezolizumabe e tiragolumabe comparado com durvalumabe em participantes com câncer de pulmão de células não pequenas (NSCLC) estágio III localmente avançado e irressecável (SKYSCRAPER-03)
7 de maio de 2026 atualizado por: Hoffmann-La Roche
Um estudo randomizado de fase III, aberto, de atezolizumabe e tiragolumabe comparado com Durvalumabe em pacientes com câncer de pulmão de células não pequenas localmente avançado e irressecável em estágio III que não progrediram após quimiorradiação concomitante à base de platina
O objetivo deste estudo é avaliar a eficácia e a segurança de atezolizumabe em combinação com tiragolumabe em comparação com durvalumabe em participantes com câncer de pulmão de células não pequenas (NSCLC) estágio III localmente avançado e irressecável que receberam pelo menos dois ciclos de tratamento concomitante com platina. baseados em quimiorradioterapia (CRT) e não tiveram progressão radiográfica da doença.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
829
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Braunschweig, Alemanha, 38114
- Klinikum Braunschweig
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Cologne, Alemanha, 51109
- Klinikum Koeln-Merheim
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Göttingen, Alemanha, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, Alemanha, 69126
- Thoraxklinik Heidelberg gGmbH
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München, Alemanha, 81925
- Klinikum Bogenhausen
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Regensburg, Alemanha, 93053
- Universitätsklinikum Regensburg
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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, Austrália, 2148
- Blacktown Hospital
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Campbelltown, New South Wales, Austrália, 2560
- Macarthur Cancer Therapy Centre
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Kogarah, New South Wales, Austrália, 2217
- St George Hospital
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South Australia
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Bedford Park, South Australia, Austrália, 5042
- Flinders Medical Centre
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Victoria
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Victoria, Victoria, Austrália, 3168
- Monash Health Translational Precinct
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Western Australia
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Bull Creek, Western Australia, Austrália, 6149
- Fiona Stanley Hospital
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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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Charleroi, Bélgica, 6000
- GHdC Site Les Viviers
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Ghent, Bélgica, 9000
- AZ Maria Middelares
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Hasselt, Bélgica, 3500
- Jessa Zkh (Campus Virga Jesse)
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British Columbia
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Abbotsford British Columbia, British Columbia, Canadá, V2S 0C2
- BC Cancer ? Abbotsford
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Victoria, British Columbia, Canadá, V8R 6V5
- BC Cancer - Victoria
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Ontario
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Barrie, Ontario, Canadá, L4M 6M2
- Royal Victoria Regional Health Centre
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Brampton, Ontario, Canadá, L6R 3J7
- William Osler Health System Brampton Civic Hospital
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Ottawa, Ontario, Canadá, 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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Cheongju-si, Coréia do Sul, 28644
- Chungbuk National University Hospital
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Daegu, Coréia do Sul, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, Coréia do Sul, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Coréia do Sul, 16247
- St. Vincent's Hospital
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Gyeonggi-do, Coréia do Sul, 10408
- National Cancer Center
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Gyeonggi-do, Coréia do Sul, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, Coréia do Sul, 50612
- Pusan National University Yangsan Hospital
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Incheon, Coréia do Sul, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Coréia do Sul, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Seoul, Coréia do Sul, 08308
- Korea University Guro Hospital
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Seoul, Coréia do Sul, 06591
- Seoul St Mary's Hospital
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Ulsan, Coréia do Sul, 44033
- Ulsan University Hosiptal
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A Coruña, Espanha, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, Espanha, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Espanha, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Espanha, 28046
- Hospital Universitario La Paz
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Madrid, Espanha, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, Espanha, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, Espanha, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Espanha, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Espanha, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, Espanha, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, Espanha, 12002
- Hospital Provincial de Castellon
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California
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Palo Alto, California, Estados Unidos, 94305
- Stanford University
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Colorado
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Greeley, Colorado, Estados Unidos, 80631
- Banner MD Anderson Cancer Center
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Florida
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Fort Myers, Florida, Estados Unidos, 33901-8101
- Florida Cancer Specialists
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Palm Bay, Florida, Estados Unidos, 32901
- Cancer Care Centers of Brevard
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Pensacola, Florida, Estados Unidos, 32503
- Woodlands Medical Specialists, P.A.
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St. Petersburg, Florida, Estados Unidos, 33705
- Florida Cancer Specialist, North Region
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Georgia
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Marietta, Georgia, Estados Unidos, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, Estados Unidos, 61615
- Illinois Cancer Care
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Maine
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Brunswick, Maine, Estados Unidos, 04011
- New England Cancer Specialists
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Massachusetts
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Fairhaven, Massachusetts, Estados Unidos, 02719
- Southcoast Health System
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Minnesota Oncology Hematology
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Missouri
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Kansas City, Missouri, Estados Unidos, 64132
- HCA Midwest Health
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Springfield, Missouri, Estados Unidos, 65807
- Cox Health Systems
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Estados Unidos, 89106
- Optum Health Care
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New Jersey
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East Brunswick, New Jersey, Estados Unidos, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
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New Mexico
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Farmington, New Mexico, Estados Unidos, 87401
- San Juan Oncology Associates
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New York
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Albany, New York, Estados Unidos, 12208
- New York Oncology Hematology,P.C.-Albany
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New York, New York, Estados Unidos, 10029
- Mount Sinai Medical Center
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The Bronx, New York, Estados Unidos, 10461
- Montefiore Medical Center
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- Prisma Health ? Upstate
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37403
- Tennessee Oncology Chattanooga
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Nashville, Tennessee, Estados Unidos, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Virginia
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Fairfax, Virginia, Estados Unidos, 22031
- Virginia Cancer Specialists
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Norfolk, Virginia, Estados Unidos, 23502
- Virginia Oncology Associates
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Angers, França, 49933
- CHU Angers
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Caen, França, 14000
- Centre François Baclesse
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Marseille, França, 13015
- Hopital Nord AP-HM
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Montpellier, França, 34070
- Clinique Clementville
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Vantoux, França, 57070
- Hôpital Robert Schuman
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Villejuif, França, 94805
- Institut Gustave Roussy
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Asvestochóri, Grécia, 570 10
- General Hospital "G.Papanikolaou"
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Athens, Grécia, 11527
- Sotiria Hospital
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Kifissia, Grécia, 145 64
- Agioi Anargyroi Cancer Hospital
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Amersfoort, Holanda, 3813 TZ
- Meander Medisch Centrum
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Breda, Holanda, 4819 EV
- Amphia Ziekenhuis
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Leidschendam, Holanda, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
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Sittard-Geleen, Holanda, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
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Hong Kong, Hong Kong
- Tuen Mun Hospital
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Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- Queen Elizabeth Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- Princess Margaret Hospital, Oncology
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Pokfulam, Hong Kong, DUMMY_VALUE
- Queen Mary Hospital
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Pécs, Hungria, 7623
- Pecsi Tudomanyegyetem
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Tatabánya, Hungria, 2800
- Szent Borbala Korhaz
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Törökbálint, Hungria, 2045
- Tudogyogyintezet Torokbalint
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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, Itália, 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, Itália, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Parma, Emilia-Romagna, Itália, 43100
- Azienda Ospedaliero Universitaria di Parma
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Lazio
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Rome, Lazio, Itália, 00128
- Policlinico Universitario Campus Biomedico
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Rome, Lazio, Itália, 00144
- IRCCS Istituto Regina Elena (IFO)
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Liguria
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Genoa, Liguria, Itália, 16132
- IRCCS AOU San Martino - IST
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Lombardy
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Brescia, Lombardy, Itália, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
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Milan, Lombardy, Itália, DUMMY_VALUE
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Pavia, Lombardy, Itália, 27100
- Fondazione IRCCS Policlinico San Matteo
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Tuscany
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Pisa, Tuscany, Itália, 56124
- Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
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Veneto
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Vicenza, Veneto, Itália, 36100
- Azienda ULSS 8 Berica
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Aichi, Japão, 464-8681
- Aichi Cancer Center
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Chiba, Japão, 277-8577
- National Cancer Center East
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Hyōgo, Japão, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, Japão, 252-0375
- Kitasato University Hospital
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Kyoto, Japão, 606-8507
- Kyoto University Hospital
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Miyagi, Japão, 981-0914
- Sendai Kousei Hospital
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Niigata, Japão, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japão, 589-8511
- Kindai University Hospital
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Saitama, Japão, 362-0806
- Saitama Cancer Center
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Shizuoka, Japão, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japão, 104-0045
- National Cancer Center Hospital
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Tokyo, Japão, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, Japão, 641-8510
- Wakayama Medical University Hospital
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Auckland, Nova Zelândia, 1023
- Auckland City Hospital, Cancer and Blood Research
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Gda?sk, Polônia, 80-214
- Uniwersyteckie Centrum Kliniczne
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Olsztyn, Polônia, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
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Otwock, Polônia, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Warsaw, Polônia, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
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Wroc?aw, Polônia, 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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Birmingham, Reino Unido, B9 5SS
- Birmingham Heartlands Hospital
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Cambridge, Reino Unido, CB2 0QQ
- Addenbrooke's NHS Trust
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Glasgow, Reino Unido, G12 0YN
- Beatson West of Scotland Cancer Centre
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Huddersfield, Reino Unido, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
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Leicester, Reino Unido, LE1 5WW
- Leicester Royal Infirmary
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Maidstone, Reino Unido, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
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Manchester, Reino Unido, M20 4BX
- Christie Foundation Trust
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Sheffield, Reino Unido, S10 2SJ
- Weston Park Hospital
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Bangkok, Tailândia, 10400
- Rajavithi Hospital
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Bangkok, Tailândia, 10300
- Vajira Hospital
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Bangkok, Tailândia, 10400
- Ramathibodi Hospital;Medicine/Oncology
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Songkhla, Tailândia, 90110
- Songklanagarind Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Adana, Turquia (Türkiye), 01220
- Adana Baskent University Medical Faculty
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Ankara, Turquia (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, Turquia (Türkiye), 06100
- Ankara University Medical Faculty
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Ankara, Turquia (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, Turquia (Türkiye), 35100
- Ege University Medical Faculty
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Diyarbakır, Turquia (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, Turquia (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turquia (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Turquia (Türkiye), 34214
- Medipol University Medical Faculty
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Malatya, Turquia (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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Innsbruck, Áustria, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, Áustria, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, Áustria, 1140
- Klinik Penzing
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Status de Desempenho do Eastern Cooperative Oncology Group (ECOG) de 0 ou 1
- NSCLC documentado histologicamente ou citologicamente com NSCLC de estágio III localmente avançado e irressecável de histologia escamosa ou não escamosa
- Tomografia computadorizada por emissão de pósitrons (PET-CT) de corpo inteiro, realizada antes e dentro de 42 dias após a primeira dose de quimiorradioterapia concomitante (cCRT)
- Pelo menos dois ciclos anteriores de quimioterapia à base de platina administrados simultaneamente com radioterapia (RT), que devem ser concluídos dentro de 1 a 42 dias antes da randomização no estudo (um ciclo de cCRT é definido como 21 ou 28 dias)
- O componente de radioterapia (RT) no cCRT deve ter sido em uma dose total de radiação de 60 (±10 por cento [%]) gray (Gy) (54 Gy a 66 Gy) administrado por RT modulada de intensidade (preferencial) ou 3D- técnica conforme
- Sem progressão durante ou após TRC concomitante à base de platina
- Um resultado PD-L1 conhecido
- Expectativa de vida >/= 12 semanas
- Função hematológica e de órgão-alvo adequada
- As participantes do sexo feminino devem estar dispostas a evitar a gravidez por 90 dias após a dose final de tiragolumabe e 5 meses após a dose final de atezolizumabe, ou por 3 meses após a dose final de durvalumabe
- Participantes do sexo masculino devem permanecer abstinentes ou usar preservativo durante o período de tratamento e por 90 dias após a dose final de tiragolumabe
- Participantes do sexo masculino não devem doar esperma durante o período de tratamento e por 90 dias após a dose final de tiragolumabe
Critério de exclusão:
- Qualquer história de NSCLC anterior e/ou qualquer história de tratamento anterior para NSCLC (os participantes devem ser diagnosticados recentemente com doença de estágio III irressecável)
- NSCLC conhecido por ter uma mutação no gene do receptor do fator de crescimento epidérmico (EGFR) ou um oncogene de fusão da quinase do linfoma anaplásico (ALK)
- Qualquer evidência de doença em estágio IV
- Tratamento com TRC sequencial para NSCLC localmente avançado
- Participantes com NSCLC localmente avançado que progrediram durante ou após o cCRT definitivo antes da randomização
- Qualquer toxicidade não resolvida de Grau > 2 do CRT anterior
- Grau >= 2 pneumonite de TRC anterior
- Ativo ou histórico de doença autoimune ou deficiência imunológica
- História de fibrose pulmonar idiopática, pneumonia em organização, pneumonite induzida por drogas ou pneumonite idiopática ou evidência de pneumonite ativa
- História de malignidade diferente de NSCLC dentro de 5 anos antes da triagem, com exceção de malignidades com risco insignificante de metástase ou morte
- Transplante alogênico prévio de células-tronco ou órgãos sólidos
- Infecção ativa pelo vírus Epstein-Barr (EBV) ou infecção ativa crônica conhecida ou suspeita por EBV na triagem
- Tratamento com terapia experimental dentro de 28 dias antes do início do tratamento do estudo
- Tratamento prévio com agonistas de CD137 ou terapias de bloqueio de ponto de controle imunológico, incluindo proteína 4 associada a linfócitos T anticitotóxicas, imunorreceptor anti-célula T com domínios Ig e ITIM (anti-TIGIT), anti-PD-1 e anti-PD-L1
- Qualquer evento adverso imunomediado de Grau >/= 3 anterior ou qualquer evento adverso imunomediado de Grau > 1 não resolvido durante o recebimento de qualquer agente imunoterápico anterior, exceto agentes de bloqueio de ponto de controle imunológico
- Tratamento com medicação imunossupressora sistêmica
- Mulheres que estão grávidas ou amamentando
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Atezolizumabe + Tiragolumabe
Os participantes receberão atezolizumabe administrado por via intravenosa (IV) no dia 1 de cada ciclo de 28 dias seguido de tiragolumabe administrado por via intravenosa no dia 1 de cada ciclo de 28 dias por um máximo de 13 ciclos.
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Atezolizumabe 1680 mg a cada 4 semanas (Q4W) será administrado IV no Dia 1 de cada ciclo de 28 dias.
Outros nomes:
Tiragolumabe 840 mg Q4W será administrado IV no Dia 1 de cada ciclo de 28 dias.
Outros nomes:
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Comparador Ativo: Durvalumabe
Os participantes receberão durvalumabe administrado IV durante cada ciclo de 28 dias por um máximo de 13 ciclos.
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Durvalumabe será administrado com base no peso a 10 mg/kg IV a cada 2 semanas (Q2W) nos dias 1 e 15 de cada ciclo de 28 dias, ou será administrado em uma dose fixa de 1500 mg IV a cada 4 semanas (Q4W) ( para participantes cujo peso >/= 30 kg) no Dia 1 de cada ciclo de 28 dias.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Prazo: 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
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS) in PPAS
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Clinical Trials, Hoffmann-La Roche
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
24 de agosto de 2020
Conclusão Primária (Real)
27 de maio de 2025
Conclusão do estudo (Real)
31 de julho de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
13 de agosto de 2020
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de agosto de 2020
Primeira postagem (Real)
14 de agosto de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Neoplasias por local
- Neoplasias
- Doenças Respiratórias
- Doenças pulmonares
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Carcinoma pulmonar de células não pequenas
- Agentes Antineoplásicos Imunológicos
- Inibidores de Ponto de Verificação Imunológica
- Agentes Antineoplásicos
- Mecanismos Moleculares de Ação Farmacológica
- durValumab
- Atezolizumab
- Tiragolumab
Outros números de identificação do estudo
- GO41854
- 2019-004773-29 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Pesquisadores qualificados podem solicitar acesso a dados individuais de pacientes por meio da plataforma de solicitação de dados de estudos clínicos (www.vivli.org).
Mais detalhes sobre os critérios da Roche para estudos elegíveis estão disponíveis aqui (https://vivli.org/members/ourmembers/). Para obter mais detalhes sobre a Política Global da Roche sobre o Compartilhamento de Informações Clínicas e como solicitar acesso a documentos de estudos clínicos relacionados, consulte aqui (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .