Un estudio de atezolizumab y tiragolumab en comparación con durvalumab en participantes con cáncer de pulmón de células no pequeñas (NSCLC) en estadio III localmente avanzado e irresecable (SKYSCRAPER-03)
7 de mayo de 2026 actualizado por: Hoffmann-La Roche
Un estudio de fase III, abierto, aleatorizado de atezolizumab y tiragolumab en comparación con durvalumab en pacientes con cáncer de pulmón de células no pequeñas en estadio III localmente avanzado e irresecable que no han progresado después de quimiorradiación concurrente basada en platino
El propósito de este estudio es evaluar la eficacia y la seguridad de atezolizumab en combinación con tiragolumab en comparación con durvalumab en participantes con cáncer de pulmón no microcítico (NSCLC) en estadio III localmente avanzado e irresecable que han recibido al menos dos ciclos de platino- basada en quimiorradioterapia (QRT) y no han tenido progresión radiográfica de la enfermedad.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
829
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Braunschweig, Alemania, 38114
- Klinikum Braunschweig
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Cologne, Alemania, 51109
- Klinikum Koeln-Merheim
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Göttingen, Alemania, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, Alemania, 69126
- Thoraxklinik Heidelberg gGmbH
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München, Alemania, 81925
- Klinikum Bogenhausen
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Regensburg, Alemania, 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, Australia, 2148
- Blacktown Hospital
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Campbelltown, New South Wales, Australia, 2560
- Macarthur Cancer Therapy Centre
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Kogarah, New South Wales, Australia, 2217
- St George Hospital
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Flinders Medical Centre
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Victoria
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Victoria, Victoria, Australia, 3168
- Monash Health Translational Precinct
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Western Australia
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Bull Creek, Western Australia, Australia, 6149
- Fiona Stanley Hospital
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Innsbruck, Austria, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, Austria, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, Austria, 1140
- Klinik Penzing
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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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Cheongju-si, Corea del Sur, 28644
- Chungbuk National University Hospital
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Daegu, Corea del Sur, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, Corea del Sur, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Corea del Sur, 16247
- St. Vincent's Hospital
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Gyeonggi-do, Corea del Sur, 10408
- National Cancer Center
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Gyeonggi-do, Corea del Sur, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, Corea del Sur, 50612
- Pusan National University Yangsan Hospital
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Incheon, Corea del Sur, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Corea del Sur, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Corea del Sur, 03080
- Seoul National University Hospital
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Seoul, Corea del Sur, 05505
- Asan Medical Center
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Seoul, Corea del Sur, 06351
- Samsung Medical Center
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Seoul, Corea del Sur, 08308
- Korea University Guro Hospital
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Seoul, Corea del Sur, 06591
- Seoul St Mary's Hospital
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Ulsan, Corea del Sur, 44033
- Ulsan University Hosiptal
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A Coruña, España, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, España, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, España, 28041
- Hospital Universitario 12 de Octubre
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Madrid, España, 28046
- Hospital Universitario La Paz
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Madrid, España, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, España, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, España, 41013
- Hospital Universitario Virgen del Rocío
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Seville, España, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, España, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, España, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, España, 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, Francia, 49933
- CHU Angers
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Caen, Francia, 14000
- Centre François Baclesse
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Marseille, Francia, 13015
- Hopital Nord AP-HM
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Montpellier, Francia, 34070
- Clinique Clementville
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Vantoux, Francia, 57070
- Hôpital Robert Schuman
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Villejuif, Francia, 94805
- Institut Gustave Roussy
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Asvestochóri, Grecia, 570 10
- General Hospital "G.Papanikolaou"
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Athens, Grecia, 11527
- Sotiria Hospital
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Kifissia, Grecia, 145 64
- Agioi Anargyroi Cancer Hospital
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Hong Kong, Hong Kong
- Tuen Mun Hospital
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Hong Kong, Hong Kong
- Pamela Youde Nethersole Eastern Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- Queen Elizabeth Hospital
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Hong Kong, Hong Kong, DUMMY_VALUE
- Princess Margaret Hospital, Oncology
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Pokfulam, Hong Kong, DUMMY_VALUE
- Queen Mary Hospital
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Pécs, Hungría, 7623
- Pecsi Tudomanyegyetem
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Tatabánya, Hungría, 2800
- Szent Borbala Korhaz
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Törökbálint, Hungría, 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, 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, Japón, 464-8681
- Aichi Cancer Center
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Chiba, Japón, 277-8577
- National Cancer Center East
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Hyōgo, Japón, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, Japón, 252-0375
- Kitasato University Hospital
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Kyoto, Japón, 606-8507
- Kyoto University Hospital
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Miyagi, Japón, 981-0914
- Sendai Kousei Hospital
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Niigata, Japón, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japón, 589-8511
- Kindai University Hospital
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Saitama, Japón, 362-0806
- Saitama Cancer Center
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Shizuoka, Japón, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japón, 104-0045
- National Cancer Center Hospital
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Tokyo, Japón, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, Japón, 641-8510
- Wakayama Medical University Hospital
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Auckland, Nueva Zelanda, 1023
- Auckland City Hospital, Cancer and Blood Research
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Amersfoort, Países Bajos, 3813 TZ
- Meander Medisch Centrum
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Breda, Países Bajos, 4819 EV
- Amphia Ziekenhuis
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Leidschendam, Países Bajos, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
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Sittard-Geleen, Países Bajos, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
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Gda?sk, Polonia, 80-214
- Uniwersyteckie Centrum Kliniczne
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Olsztyn, Polonia, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
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Otwock, Polonia, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Warsaw, Polonia, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
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Wroc?aw, Polonia, 53-413
- Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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Beijing, Porcelana, 101149
- Beijing Chest Hospital
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Beijing, Porcelana, 100142
- Beijing Cancer Center
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Changchun, Porcelana, 132013
- Jilin cancer hospital
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Changsha, Porcelana, 410008
- Xiangya Hospital Central South University
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Chengdu, Porcelana, 610041
- Sichuan Provincial Cancer Hospital
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Chongqing, Porcelana, 400030
- Chongqing Cancer Hospital
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Fujian, Porcelana, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Porcelana, 350014
- Fujian Provincial Cancer Hospital
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Guangzhou, Porcelana, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, Porcelana, 310002
- Hangzhou Cancer Hospital
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Jinan, Porcelana, 250117
- Shandong Cancer Hospital
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Nanjing, Porcelana, 210009
- Zhongda Hospital Affiliated to Southeast University
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Qingdao, Porcelana, 266042
- The Affiliated Hospital of Qingdao University
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Shanghai, Porcelana, 200000
- Shanghai Chest Hospital
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Shantou, Porcelana, 515041
- Cancer Hospital of Shantou University Medical College
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Taiyuan, Porcelana, 030013
- Shanxi Provincial Cancer Hospital
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Tianjin, Porcelana, 300060
- Tianjin Cancer Hospital
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Wenzhou, Porcelana, 325000
- The 2nd School of Medicine, WMU
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Xiamen, Porcelana, 361003
- The First Affiliated Hospital of Xiamen University
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Xuzhou, Porcelana, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Zhengzhou, Porcelana, 450008
- Henan Cancer Hospital
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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, Tailandia, 10400
- Rajavithi Hospital
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Bangkok, Tailandia, 10300
- Vajira Hospital
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Bangkok, Tailandia, 10400
- Ramathibodi Hospital;Medicine/Oncology
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Songkhla, Tailandia, 90110
- Songklanagarind Hospital
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Taichung, Taiwán, 40447
- China Medical University Hospital
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Taipei, Taiwán, 112
- Taipei Veterans General Hospital
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Adana, Turquía (Türkiye), 01220
- Adana Baskent University Medical Faculty
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Ankara, Turquía (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, Turquía (Türkiye), 06100
- Ankara University Medical Faculty
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Ankara, Turquía (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, Turquía (Türkiye), 35100
- Ege University Medical Faculty
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Diyarbakır, Turquía (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, Turquía (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turquía (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Turquía (Türkiye), 34214
- Medipol University Medical Faculty
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Malatya, Turquía (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) de 0 o 1
- NSCLC documentado histológica o citológicamente con NSCLC en estadio III localmente avanzado e irresecable de histología escamosa o no escamosa
- Tomografía por emisión de positrones-tomografía computarizada (PET-CT) de cuerpo entero, realizada antes y dentro de los 42 días posteriores a la primera dosis de quimiorradioterapia concurrente (cCRT)
- Al menos dos ciclos previos de quimioterapia basada en platino administrados simultáneamente con radioterapia (RT), que deben completarse dentro de 1 a 42 días antes de la aleatorización en el estudio (un ciclo de cCRT se define como 21 o 28 días)
- El componente de radioterapia (RT) en el cCRT debe haber estado en una dosis total de radiación de 60 (±10 por ciento [%]) gray (Gy) (54 Gy a 66 Gy) administrado por RT de intensidad modulada (preferido) o 3D- técnica de conformación
- Sin progresión durante o después de la TRC concurrente basada en platino
- Un resultado conocido de PD-L1
- Esperanza de vida >/= 12 semanas
- Función hematológica y de órganos diana adecuada
- Las participantes femeninas deben estar dispuestas a evitar el embarazo durante 90 días después de la última dosis de tiragolumab y 5 meses después de la última dosis de atezolizumab, o durante 3 meses después de la última dosis de durvalumab
- Los participantes masculinos deben permanecer abstinentes o usar un condón durante el período de tratamiento y durante los 90 días posteriores a la dosis final de tiragolumab.
- Los participantes masculinos no deben donar esperma durante el período de tratamiento y durante los 90 días posteriores a la dosis final de tiragolumab.
Criterio de exclusión:
- Cualquier historial de NSCLC previo y/o cualquier historial de tratamiento previo para NSCLC (los participantes deben tener un diagnóstico reciente de enfermedad en estadio III irresecable)
- NSCLC conocido por tener una mutación en el gen del receptor del factor de crecimiento epidérmico (EGFR) o un oncogén de fusión de quinasa de linfoma anaplásico (ALK)
- Cualquier evidencia de enfermedad en estadio IV
- Tratamiento con TRC secuencial para NSCLC localmente avanzado
- Participantes con NSCLC localmente avanzado que han progresado durante o después de la cCRT definitiva antes de la aleatorización
- Cualquier toxicidad no resuelta de Grado >2 de CRT anterior
- Neumonitis de grado >= 2 por TRC previa
- Activo o antecedentes de enfermedad autoinmune o inmunodeficiencia
- Antecedentes de fibrosis pulmonar idiopática, neumonía organizada, neumonitis inducida por fármacos o neumonitis idiopática o evidencia de neumonitis activa
- Antecedentes de neoplasia maligna distinta del NSCLC en los 5 años anteriores a la selección, con la excepción de neoplasias malignas con un riesgo insignificante de metástasis o muerte.
- Trasplante alogénico previo de células madre u órganos sólidos
- Infección activa por el virus de Epstein-Barr (EBV) o infección activa crónica conocida o sospechada por EBV en la selección
- Tratamiento con terapia en investigación dentro de los 28 días anteriores al inicio del tratamiento del estudio
- Tratamiento previo con agonistas de CD137 o terapias de bloqueo de puntos de control inmunitarios, que incluyen proteína 4 asociada a linfocitos T citotóxicos, inmunorreceptores de células T con dominios Ig e ITIM (anti-TIGIT), anti-PD-1 y anti-PD-L1
- Cualquier evento adverso previo de grado >/= 3 mediado por el sistema inmunitario o cualquier evento adverso no resuelto de grado > 1 mediado por el sistema inmunitario mientras recibía cualquier agente de inmunoterapia anterior que no sean agentes de bloqueo del punto de control inmunitario
- Tratamiento con medicación inmunosupresora sistémica
- Mujeres que están embarazadas o amamantando
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Atezolizumab + Tiragolumab
Los participantes recibirán atezolizumab administrado por vía intravenosa (IV) el día 1 de cada ciclo de 28 días, seguido de tiragolumab administrado por vía IV el día 1 de cada ciclo de 28 días durante un máximo de 13 ciclos.
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Atezolizumab 1680 mg cada 4 semanas (Q4W) se administrará IV el día 1 de cada ciclo de 28 días.
Otros nombres:
Tiragolumab 840 mg Q4W se administrará IV el Día 1 de cada ciclo de 28 días.
Otros nombres:
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Comparador activo: Durvalumab
Los participantes recibirán durvalumab por vía intravenosa durante cada ciclo de 28 días durante un máximo de 13 ciclos.
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Durvalumab se administrará según el peso a 10 mg/kg IV cada 2 semanas (Q2W) en los días 1 y 15 de cada ciclo de 28 días, o se administrará a una dosis fija de 1500 mg IV cada 4 semanas (Q4W) ( para participantes cuyo peso >/= 30 kg) el Día 1 de cada ciclo de 28 días.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival (OS) in PPAS
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de agosto de 2020
Finalización primaria (Actual)
27 de mayo de 2025
Finalización del estudio (Actual)
31 de julio de 2025
Fechas de registro del estudio
Enviado por primera vez
13 de agosto de 2020
Primero enviado que cumplió con los criterios de control de calidad
13 de agosto de 2020
Publicado por primera vez (Actual)
14 de agosto de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma de pulmón de células no pequeñas
- Agentes antineoplásicos inmunológicos
- Inhibidores de puntos de control inmunitarios
- Agentes antineoplásicos
- Mecanismos moleculares de acción farmacológica.
- durvalumab
- atezolizumab
- Tiragolumab
Otros números de identificación del estudio
- GO41854
- 2019-004773-29 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Los investigadores calificados pueden solicitar acceso a datos de pacientes individuales a través de la plataforma de solicitud de datos de estudios clínicos (www.vivli.org).
Más detalles sobre los criterios de Roche para estudios elegibles están disponibles aquí (https://vivli.org/members/ourmembers/). Para obtener más detalles sobre la Política global de Roche sobre el intercambio de información clínica y cómo solicitar acceso a documentos de estudios clínicos relacionados, consulte aquí (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .