Un estudio de ociperlimab con tislelizumab en comparación con pembrolizumab en participantes con cáncer de pulmón no tratado
20 de abril de 2026 actualizado por: BeiGene
Un estudio de fase 3, aleatorizado, doble ciego de ociperlimab, un anticuerpo anti-TIGIT, en combinación con tislelizumab en comparación con pembrolizumab en pacientes con células no pequeñas previamente no tratadas, seleccionadas para PD-L1 y localmente avanzadas, irresecables o metastásicas Cáncer de pulmón
El propósito del estudio es comparar la supervivencia libre de progresión (PFS) entre el Grupo A (ociperlimab en combinación con tislelizumab) y el Grupo B (pembrolizumab en combinación con placebo) según lo evaluado por los investigadores de acuerdo con los Criterios de Evaluación de Respuesta en Tumores Sólidos Versión 1.1 ( RECIST v1.1) y para comparar la supervivencia general (SG) entre el brazo A y el brazo B.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
669
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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Aachen, Alemania, 52074
- Universitaetsklinikum Aachen
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Bonn, Alemania, 53127
- Universitatsklinikum Bonn
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Cologne, Alemania, 51109
- Kliniken der Stadt Koeln gGmbH
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Giessen, Alemania, 35392
- Uniklinikum Giessen Marburg
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Grohansdorf, Alemania, 22927
- LungenClinic Grosshansdorf GmbH
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Hamburg, Alemania, 20251
- Ambulantes Krebszentrum Hamburg
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Munich, Alemania, 81925
- Munchen Klinik Bogenhausen
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Rotenburg (Wümme), Alemania, 27356
- Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
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Buenos Aires, Argentina, 1409
- Centro Medical Austral
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San Miguel de Tucumán, Argentina, 4000
- Centro Para La Atencion Del Paciente Oncologico (Caipo)
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New South Wales
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Concord, New South Wales, Australia, 2139
- Concord Repatriation General Hospital
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St Leonards, New South Wales, Australia, 2065
- Northern Cancer Institute
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Waratah, New South Wales, Australia, 2298
- Calvary Mater Newcastle
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Queensland
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Benowa, Queensland, Australia, 4217
- Pindara Private Hospital
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Chermside, Queensland, Australia, 4032
- The Prince Charles Hospital
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South Brisbane, Queensland, Australia, 4101
- Mater Cancer Care Centre
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Tugun, Queensland, Australia, 4224
- John Flynn Private Hospital
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South Australia
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Elizabeth Vale, South Australia, Australia, 5112
- Lyell McEwin Hospital
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Victoria
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Ballarat, Victoria, Australia, 3350
- Ballarat Health Services
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Clayton, Victoria, Australia, 3168
- Monash Health
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St Albans, Victoria, Australia, 3021
- Western Health Sunshine Hospital
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- St John of God, Murdoch
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Brasília, Brasil, 70390140
- Instituto Dor de Pesquisa E Ensino Distrito Federal
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Cachoeiro de Itapemirim, Brasil, 29308-020
- Hospital Evangélico de Cachoeiro de Itapemirim
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Florianópolis, Brasil, 88034-000
- Centro de Pesquisas Oncologicas Cepon
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Fortaleza, Brasil, 60430-235
- Cancer Institute of Ceara
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Santo André, Brasil, 09060-650
- Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
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São José do Rio Preto, Brasil, 15090-000
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
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Chungcheongbukdo
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Cheongju-si, Chungcheongbukdo, Corea del Sur, 28644
- Chungbuk National University Hospital
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, Corea del Sur, 42601
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Corea del Sur, 14647
- The Catholic University of Korea Bucheon St Marys Hospital
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Gyeonggido, Gyeonggi-do, Corea del Sur, 13496
- CHA Bundang Medical Center, CHA University
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Suwon, Gyeonggi-do, Corea del Sur, 16247
- The Catholic University of Korea, St Vincents Hospital
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Gyeongsangbukdo
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Daegu, Gyeongsangbukdo, Corea del Sur, 41404
- Kyungpook National University Chilgok Hospital
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Seoul Teugbyeolsi
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Eunpyeonggu, Seoul Teugbyeolsi, Corea del Sur, 03312
- The Catholic University of Korea, Eunpyeong St Marys Hospital
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 03722
- Severance Hospital Yonsei University Health System
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Alcorcón, España, 28922
- Hospital Universitario Fundacion Alcorcon
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Barcelona, España, 08003
- Hospital Del Mar
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Barcelona, España, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, España, 08035
- Hospital Universitario Vall Dhebron
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Barcelona, España, 8028
- Hospital Universitari Quiron Dexeus
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Elche, España, 3203
- Hospital General Universitario de Elche
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Girona, España, 17007
- ICO Girona
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Jaén, España, 23007
- Hospital Universitario de Jaén
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Las Palmas, España, 35016
- Complejo Hospitalario Universitario Insular Gran Canaria
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Lugo, España, 27003
- Hospital Universitario Lucus Augusti
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Madrid, España, 28040
- Hospital Clinico San Carlos
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Madrid, España, 28046
- Hospital Universitario La Paz
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Madrid, España, 28041
- Hospital Universitario Doce de Octubre
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Madrid, España, 28040
- Start Madrid Fundacion Jimenez Diaz
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Majadahonda, España, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Murcia, España, 30008
- Hospital General Universitario Morales Meseguer
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Málaga, España, 29010
- Hospital Regional Universitario de Málaga
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Málaga, España, 29010
- Hospital Universitario Virgen de la Victoria
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Ourense, España, 32005
- Complexo Hospitalario Universitario de Ourense
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Palma de Mallorca, España, 07120
- Hospital Universitari Son Espases
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Seville, España, 41013
- Hospital Universitario Virgen del Rocío
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Seville, España, 41014
- Hospital Universitario Nuestra Señora de Valme
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Valencia, España, 46026
- Hospital Universitari i Politecnic La Fe
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Valencia, España, 46015
- Hospital Arnau de Vilanova
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California
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Fullerton, California, Estados Unidos, 92835
- Providence Medical Foundation St Jude Heritage Healthcare
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Los Angeles, California, Estados Unidos, 90067
- Valkyrie Clinical Trials
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Florida
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Ocala, Florida, Estados Unidos, 34474
- Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
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Orlando, Florida, Estados Unidos, 32804
- Advent Health Cancer Institute
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Indiana
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Goshen, Indiana, Estados Unidos, 46526
- Goshen Center for Cancer Care
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- University Medical Center New Orleans West Jefferson Medical Center
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Minnesota
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Saint Paul, Minnesota, Estados Unidos, 55101
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- West Penn Hospital
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Bayonne, Francia, 64100
- Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
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Bordeaux, Francia, 33076
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, Francia, 69317
- Hôpital de La Croix Rousse
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Lyon, Francia, 69500
- Hopital Louis Pradel
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Montpellier, Francia, 24298
- Icm Val Daurelle Oncologie Medicale
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Nancy, Francia, 54100
- Polyclinique de Gentilly
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Paris, Francia, 75014
- Hôpital Cochin
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PierreBenite, Francia, 69495
- Chu Hopital Lyon Sud
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Saint-Mandé, Francia, 94160
- HIA Begin
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Saint-Pierre, Francia, 97448
- CHU de la Réunion
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SaintHerblain, Francia, 44805
- Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
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SaintHerblain, Francia, 44805
- CHU Nantes Hopital Nord Laennec
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Tours, Francia, 37000
- Chu Tours Hopital Bretonneau Service Pneumologie
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Batumi, Georgia, 6000
- High Technology Hospital MedCenter Ltd
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Tbilisi, Georgia, 0186
- Multiprofile Clinic Consilium Medulla Ltd
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Tbilisi, Georgia, 0159
- Institute of Clinical Oncology Ltd
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Tbilisi, Georgia, 0112
- Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
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Tbilisi, Georgia, 0112
- Israel Georgian Medical Research Clinic Helsicore Ltd
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Tbilisi, Georgia, 0119
- Jsc German Hospital
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Tbilisi, Georgia, 0159
- Jsc Evex Hospitals Tbilisi
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Tbilisi, Georgia, 0160
- Tim Tbilisi Institute of Medicine Ltd
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Tbilisi, Georgia, 0186
- Caucasus Medical Centre Ltd
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Tbilisi, Georgia, 0186
- Oncology Research Center Ltd
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Bologna, Italia, 40138
- Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
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Messina, Italia, 98158
- Azienda Ospedaliera Papardo
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Orbassano, Italia, 10043
- AOU San Luigi Gonzaga
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Hiroshima, Japón, 734-8551
- Hiroshima University Hospital
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Niigata, Japón, 951-8566
- Niigata Cancer Center Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japón, 466-8560
- Nagoya University Hospital
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Aomori
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Hirosaki, Aomori, Japón, 036-8563
- Hirosaki University Hospital
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Ehime
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Matsuyama, Ehime, Japón, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka
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Kurume, Fukuoka, Japón, 830-0011
- Kurume University Hospital
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Gunma
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Shibukawa, Gunma, Japón, 337-0280
- National Hospital Organization Shibukawa Medical Center
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Hyōgo
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Kobe, Hyōgo, Japón, 650-0017
- Kobe University Hospital
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Kobe, Hyōgo, Japón, 650-0047
- Kobe City Medical Center General Hospital
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Nishinomiyashi, Hyōgo, Japón, 663-8501
- Hyogo Medical University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japón, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japón, 241-8515
- Kanagawa Cancer Center
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Miyagi
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Natorishi, Miyagi, Japón, 981-1293
- Miyagi Cancer Center
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Okayama-ken
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Okayama, Okayama-ken, Japón, 700-8558
- Okayama University Hospital
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Osaka
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Hirakata, Osaka, Japón, 573-1191
- Kansai Medical University Hospital
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Sakai, Osaka, Japón, 591-8555
- National Hospital Organization Kinki Chuo Chest Medical Center
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Sayama, Osaka, Japón, 589-8511
- Kindai University Hospital
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Toyonaka, Osaka, Japón, 560-8552
- Osaka Toneyama Medical Center
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Tochigi
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Shimonotsuke, Tochigi, Japón, 329-0498
- Jichi Medical University Hospital
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Shimotsugagun, Tochigi, Japón, 321-0293
- Dokkyo Medical University Hospital
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Utsunomiya, Tochigi, Japón, 320-0834
- Tochigi Cancer Center
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Tokyo
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Bunkyoku, Tokyo, Japón, 113-8603
- Nippon Medical School Hospital
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Kotoku, Tokyo, Japón, 135-8550
- Cancer Institute Hospital of JFCR
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Amersfoort, Países Bajos, 3813 TZ
- Meander Medisch Centrum
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Arnhem, Países Bajos, 6815 AD
- Rijnstate
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Harderwijk, Países Bajos, 3844 DG
- Ziekenhuis St Jansdal
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Heerlen, Países Bajos, 6419 PC
- Stichting Zuyderland Medisch Centrum
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Zwolle, Países Bajos, 8025 AB
- Isala Klinieken Zwolle
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Bialystok, Polonia, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Lodz, Polonia, 93-510
- Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lodz, Polonia, 90-338
- Centrum Terapii Wspoczesnej
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Poznan, Polonia, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
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Poznan, Polonia, 60-693
- Przychodnia Med Polonia Sp Z Oo
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Zamość, Polonia, 22-400
- ETG Zamość
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Anhui
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Hefei, Anhui, Porcelana, 230601
- The Second Hospital of Anhui Medical University
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Hefei, Anhui, Porcelana, 230000
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Porcelana, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, Porcelana, 100020
- Beijing Chao Yang Hospital
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Beijing, Beijing Municipality, Porcelana, 101149
- Beijing Chest Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Porcelana, 400030
- Chongqing Cancer Hospital
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Chongqing, Chongqing Municipality, Porcelana, 400042
- Daping Hospital, Third Military Medical University
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Chongqing, Chongqing Municipality, Porcelana, 400038
- The First Affiliated Hospital of Army Military Medical University
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Chongqing, Chongqing Municipality, Porcelana, 404000
- Chongqing University Three Gorges Central Hospital
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Fujian
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Fuzhou, Fujian, Porcelana, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, Porcelana, 350014
- Fujian Cancer Hospital
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Xiamen, Fujian, Porcelana, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510030
- Affiliated Cancer Hospital and institute of Guangzhou Medical University
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Shantou, Guangdong, Porcelana, 515031
- Cancer Hospital of Shantou University Medical College
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Shenzhen, Guangdong, Porcelana, 518020
- Shenzhen Peoples Hospital
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Guangxi
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Nanning, Guangxi, Porcelana, 530021
- The Peoples Hospital of Guangxi Zhuang Autonomous Region
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Nanning, Guangxi, Porcelana, 530021
- The Tumor Hospital Affiliated to Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, Porcelana, 150000
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Porcelana, 450052
- The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, Porcelana, 450000
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Porcelana, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, Porcelana, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Hubei, Porcelana, 430022
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Porcelana, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, Porcelana, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Changzhou, Jiangsu, Porcelana, 213003
- Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
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Nanjing, Jiangsu, Porcelana, 210029
- Nanjing Chest Hospital
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Nanjing, Jiangsu, Porcelana, 210009
- Nanjing First Hospital
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Suzhou, Jiangsu, Porcelana, 215000
- The Second Affiliated Hospital of Soochow University
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Suzhou, Jiangsu, Porcelana, 215006
- The First Affiliated Hospital of Soochow University Branch Shizi
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Xuzhou, Jiangsu, Porcelana, 221000
- Xuzhou Central Hospital
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Liaoning
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Shenyang, Liaoning, Porcelana, 110042
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Shandong
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Qingdao, Shandong, Porcelana, 266000
- The Affiliated Hospital of Qingdao University Branch Laoshan
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Weifang, Shandong, Porcelana, 261000
- Weifang Peoples Hospital
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Yantai, Shandong, Porcelana, 264000
- Yantai YuHuangDing Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200433
- Shanghai Pulmonary Hospital
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Shanghai, Shanghai Municipality, Porcelana, 200030
- Shanghai Chest Hospital
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Affiliated Zhongshan Hospital of Fudan University
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Shanxi
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Taiyuan, Shanxi, Porcelana, 030032
- Shanxi Bethune Hospital
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- West China Hospital, Sichuan University
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Chengdu, Sichuan, Porcelana, 610041
- Sichuan Cancer Hospital and Institute
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Nanchong, Sichuan, Porcelana, 637000
- Affiliated Hospital of North Sichuan Medical College
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Tianjin, Tianjin Municipality, Porcelana, 300052
- Tianjin Medical University General Hospital
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Xinjiang
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Ürümqi, Xinjiang, Porcelana, 830000
- Affiliated Cancer Hospital of Xinjiang Medical University
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Porcelana, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Ningbo, Zhejiang, Porcelana, 315010
- The First Affiliated Hospital of Ningbo University
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Taizhou, Zhejiang, Porcelana, 317000
- Taizhou Hospital of Zhejiang
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Yiwu, Zhejiang, Porcelana, 322000
- The Fourth Affiliated Hospital Zhejiang University School of Medicine
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Arkhangelskaya oblast
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Arkhangelsk, Arkhangelskaya oblast, Rusia, 163045
- Arkhangelsk Regional Clinical Oncological Dispensary
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Bashkortostan Republic
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Ufa, Bashkortostan Republic, Rusia, 450054
- State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic
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Chelyabinsk Oblast
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Magnitogorsk, Chelyabinsk Oblast, Rusia, 455001
- State Budgetary Healthcare Institution Regional Oncology Dispensary Number
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Moscow
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Moscow, Moscow, Rusia, 121309
- VitaMed LLC
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Nizhny Novgorod Oblast
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Nizhny Novgorod, Nizhny Novgorod Oblast, Rusia, 603081
- State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
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Omsk Oblast
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Omsk, Omsk Oblast, Rusia, 644013
- Bih of Omsk Region Clinical Oncology Dispensary
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Samaraskaya Oblast'
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Samara, Samaraskaya Oblast', Rusia, 443031
- State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Rusia, 197082
- Llc Av Medical Group
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Bangkok, Tailandia, 10700
- Siriraj Hospital
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Hat Yai, Tailandia, 90110
- Songklanagarind Hospital (Prince of Songkhla University)
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Lak Si, Tailandia, 10210
- Chulabhorn Research Institute
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Muang, Tailandia, 50200
- Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
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Muang, Tailandia, 40002
- Srinagarind Hospital (Khon Kaen University)
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Ratchathewi, Tailandia, 10400
- Phramongkutklao Hospital
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Ratchathewi, Tailandia, 10400
- Rajavithi Hospital
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Changhua, Taiwán, 50006
- Changhua Christian Hospital
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Kaohsiung City, Taiwán, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, Taiwán, 40201
- Chung Shan Medical University Hospital
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Taipei, Taiwán, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwán, 231405
- Taipei Tzu Chi Hospital
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Taoyuan, Taiwán, 33305
- Linkou Chang Gung Memorial Hospital
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Yunlin, Taiwán, 640
- National Taiwan University Hospital Yunlin Branch
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Adana, Turquía (Türkiye), 01130
- Acibadem Adana Hospital
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Adana, Turquía (Türkiye), 1240
- Baskent University Practice and Research Hospital Adana Medical Oncology Department
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Ankara, Turquía (Türkiye), 6520
- Memorial Ankara Hospital
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Ankara, Turquía (Türkiye), 06200
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Battalgazi, Turquía (Türkiye), 44280
- Inonu Universitesi Tip Fakultesi
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Edirne, Turquía (Türkiye), 22030
- Tr Trakya University Health Research and Application Center (Hospital)
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Istanbul, Turquía (Türkiye), 34098
- Iu C, Clinical Research Excellence Application and Research Center
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Istanbul, Turquía (Türkiye), 34722
- Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
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Izmir, Turquía (Türkiye), 35100
- Ege University Medical Faculty
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Kocaeli, Turquía (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi
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Meram, Turquía (Türkiye), 42090
- Necmettin Erbakan University Selcuklu Faculty of Medicine
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Mersin City Hospital, Turquía (Türkiye), 33240
- Mersin City Hospital
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Kryvyi Rih, Ucrania, 50000
- Medical Center of Limited Liability Company Mriya Med Service
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Uzhhorod, Ucrania, 88000
- Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
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Uzhhorod, Ucrania, 88011
- Zakarpatska Regional Clinical Oncological 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 clave de inclusión:
- Cáncer de pulmón no microcítico (NSCLC) localmente avanzado o recurrente documentado histológica o citológicamente que no es elegible para cirugía curativa y/o radioterapia definitiva con o sin quimiorradioterapia, o NSCLC metastásico no escamoso o escamoso.
- Sin tratamiento sistémico previo para NSCLC metastásico.
- Acuerdo para proporcionar tejido de archivo o biopsia fresca (si no hay tejido de archivo disponible).
- Tumores con PD-L1 expresado en ≥ 50% de células tumorales.
- Al menos 1 lesión medible según lo definido por RECIST v1.1.
- Estado de rendimiento ECOG ≤ 1.
Criterios clave de exclusión:
- Mutaciones conocidas en el gen del receptor del factor de crecimiento epidérmico (EGFR), el oncogén de fusión de la quinasa del linfoma anaplásico (ALK), BRAF V600E o ROS1.
- Terapia previa con una proteína de muerte celular antiprogramada (anti-PD)-1, ligando anti-PD (L)-1, ligando anti-PD-2, inmunoglobulina anti-células T e ITIM (anti-TIGIT) dominio, o cualquier otro anticuerpo o fármaco dirigido específicamente a la coestimulación de células T o vías de puntos de control.
- Enfermedad leptomeníngea activa o metástasis cerebral no controlada y no tratada.
- Enfermedades autoinmunes activas o antecedentes de enfermedades autoinmunes que pueden recaer.
Nota: Es posible que se apliquen otros criterios de inclusión/exclusión definidos en el protocolo
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Arm A: Ociperlimab plus Tislelizumab
Participants received ociperlimab 900 mg and tislelizumab 200 mg intravenously every 3 weeks.
Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
|
Tislelizumab es un anticuerpo monoclonal formulado para inyección intravenosa.
Otros nombres:
Ociperlimab es un anticuerpo monoclonal formulado para inyección intravenosa.
Otros nombres:
|
|
Comparador activo: Arm B: Pembrolizumab plus Placebo
Participants received pembrolizumab 200 mg and placebo intravenously every 3 weeks.
Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
|
Pembrolizumab es un anticuerpo monoclonal formulado para inyección intravenosa.
Otros nombres:
Las infusiones de placebo consistirán en una solución salina normal estéril.
|
|
Comparador de placebos: Arm C: Tislelizumab plus Placebo
Participants received tislelizumab 200 mg and placebo intravenously every 3 weeks.
Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
|
Tislelizumab es un anticuerpo monoclonal formulado para inyección intravenosa.
Otros nombres:
Las infusiones de placebo consistirán en una solución salina normal estéril.
|
|
Experimental: Safety Run-In Substudy
Japanese participants received ociperlimab 900 mg and tislelizumab 200 mg every 3 weeks.
Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
|
Tislelizumab es un anticuerpo monoclonal formulado para inyección intravenosa.
Otros nombres:
Ociperlimab es un anticuerpo monoclonal formulado para inyección intravenosa.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival (OS) in Arms A and B
Periodo de tiempo: From randomization until the end of the study. Maximum time on study was 45.0 months
|
OS is defined as the time from the date of randomization to the date of death due to any cause.
Median OS was estimated using the Kaplan-Meier method.
OS was a pre-specified primary endpoint for Arms A and B only.
|
From randomization until the end of the study. Maximum time on study was 45.0 months
|
|
Safety Run-In Substudy: Number of Participants Experiencing Adverse Events (AEs)
Periodo de tiempo: From first dose of study drug to 30 days after last dose. Maximum treatment duration was 12.45 months.
|
The severity of AEs was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0). AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being the least severe and Grade 5 being the most severe. An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, was considered a significant medical AE by the investigator based on medical judgement. |
From first dose of study drug to 30 days after last dose. Maximum treatment duration was 12.45 months.
|
|
Safety Run-In Substudy: Serum Concentration of Ociperlimab
Periodo de tiempo: Cycle 1 Day 1 (C1D1) Postdose (30 minutes after end of infusion), 24 and 72 Hours Postdose; C1D8; C1D15; C2D1 Predose and Postdose; C5D1 Predose; C5D1 Postdose; C5D8; C5D15; C6D1 Predose and Postdose; C9D1 Predose; C13D1 Predose; End of Treatment.
|
Cycle 1 Day 1 (C1D1) Postdose (30 minutes after end of infusion), 24 and 72 Hours Postdose; C1D8; C1D15; C2D1 Predose and Postdose; C5D1 Predose; C5D1 Postdose; C5D8; C5D15; C6D1 Predose and Postdose; C9D1 Predose; C13D1 Predose; End of Treatment.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Periodo de tiempo: Up to 45.0 months
|
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, whichever occurs first. Median PFS was estimated using the Kaplan-Meier method. PFS was a pre-specified secondary endpoint for Arms A and B only. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of existing non-target lesions, or new lesions. |
Up to 45.0 months
|
|
Progression-free Survival (PFS) for Safety Run-In Substudy As Assessed By the Investigator
Periodo de tiempo: Up to 38.9 months
|
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first.
Median PFS was estimated using the Kaplan-Meier method.
|
Up to 38.9 months
|
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Overall Response Rate (ORR) for Arm A Versus Arm B As Assessed By the Investigator
Periodo de tiempo: Response was assessed every 9 weeks from randomization for the first 52 weeks and then every 12 weeks thereafter, up to 45.0 months
|
ORR is defined as the percentage of participants with a documented, confirmed complete response or partial response per RECIST v1.1. ORR was a pre-specified secondary endpoint for Arms A and B only. Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions. |
Response was assessed every 9 weeks from randomization for the first 52 weeks and then every 12 weeks thereafter, up to 45.0 months
|
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Overall Response Rate (ORR) for Safety Run-In Substudy As Assessed By the Investigator
Periodo de tiempo: Response was assessed every 9 weeks from randomization for the first 52 weeks and then every 12 weeks thereafter, up to 38.9 months
|
ORR is defined as the percentage of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
|
Response was assessed every 9 weeks from randomization for the first 52 weeks and then every 12 weeks thereafter, up to 38.9 months
|
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Duration Of Response (DOR) for Arm A Versus Arm B As Assessed By the Investigator
Periodo de tiempo: Up to 45.0 months
|
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.
Median DOR was estimated using the Kaplan-Meier method.
DOR was a pre-specified secondary endpoint for Arms A and B only.
|
Up to 45.0 months
|
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Duration Of Response (DOR) for Safety Run-In Substudy As Assessed By the Investigator
Periodo de tiempo: Up to 38.9 months
|
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever occurs first.
Median DOR was estimated using the Kaplan-Meier method.
|
Up to 38.9 months
|
|
Change From Baseline in Global Health Status (GHS)/Quality of Life (QoL), Physical Functioning, and Pain Scores: European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30) in Arms A and B
Periodo de tiempo: Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
|
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 GHS scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health QoL questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. Lower scores in symptom scales indicate better quality of life. Included in this outcome measure were evaluation of GHS/QoL, physical functioning, and fatigue. This was a pre-specified secondary endpoint for Arms A and B only. |
Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
|
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Change From Baseline in EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) Index Score, Dyspnea, Coughing, Hemoptysis, Pain in Chest, Pain in Arms/Shoulders, and Peripheral Neuropathy Scores in Arms A and B
Periodo de tiempo: Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
|
The EORTC QLQ-LC13 is the lung cancer module of the QLQ-C30 and measures lung cancer-specific disease and treatment symptoms. It includes 13 questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. The symptom index scale was calculated by taking the mean of all symptom scale scores, and ranges from 0 to 100. Lower scores indicate an improvement in symptoms. This was a pre-specified secondary endpoint for Arms A and B only. |
Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
|
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Change From Baseline in European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Visual Analog Scale in Arms A and B
Periodo de tiempo: Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
|
The EQ-5D-5L comprises a descriptive module that includes five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a Visual Analog Scale (VAS). The VAS records a participant's self-rated health on a vertical scale from 0 to 100, where 0 is 'the worst health you can imagine' and 100 is 'the best health you can imagine'. A higher score indicates better health outcomes. This was a pre-specified secondary endpoint for Arms A and B only. |
Baseline to Cycle 5 and Cycle 7, each cycle was 3 weeks
|
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Time To Deterioration (TTD) in Arms A and B Based on QLQ-LC13 Index Score, Cough, Chest Pain, Dyspnea, Hemoptysis, Arm or Shoulder Pain, and Peripheral Neuropathy
Periodo de tiempo: Up to 45.0 months
|
TTD is defined as the time from randomization to the first occurrence of worsening scores of ≥ 10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause.
TTD was estimated using the Kaplan-Meier method.
TTD was a pre-specified secondary endpoint for Arms A and B only.
|
Up to 45.0 months
|
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Time To Deterioration (TTD) in Arms A and B Based on QLQ-C30 GHS/QoL Score, Physical Functioning, and Fatigue
Periodo de tiempo: Up to 45.0 months
|
TTD is defined as the time from randomization to the first occurrence of worsening scores of ≥10 points from baseline for 2 consecutive assessments or 1 assessment followed by death from any cause.
TTD was estimated using the Kaplan-Meier method.
TTD was a pre-specified secondary endpoint for Arms A and B only.
|
Up to 45.0 months
|
|
Number Of Participants Experiencing Adverse Events (AEs) in Arm A
Periodo de tiempo: From first dose of study drug up to 30 days after last dose (or 90 days for immune-mediated AEs); maximum treatment duration was 45.0 months
|
The severity of AEs was determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0). AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being the least severe and Grade 5 being the most severe. An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. An SAE is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, was considered a significant medical AE by the investigator based on medical judgement. This was a pre-specified secondary endpoint for Arm A only. |
From first dose of study drug up to 30 days after last dose (or 90 days for immune-mediated AEs); maximum treatment duration was 45.0 months
|
|
Safety Run-In Substudy: Participants With Anti-Drug Antibodies
Periodo de tiempo: Up to 38.9 months
|
Up to 38.9 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Mark Socinski, Advent Health Orlando
- Investigador principal: Shun Lu, Shanghai Chest Hospital
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 mayo de 2021
Finalización primaria (Actual)
30 de mayo de 2025
Finalización del estudio (Actual)
18 de marzo de 2026
Fechas de registro del estudio
Enviado por primera vez
5 de febrero de 2021
Primero enviado que cumplió con los criterios de control de calidad
5 de febrero de 2021
Publicado por primera vez (Actual)
10 de febrero de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Procesos Neoplásicos
- Neoplasias Pulmonares
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Condiciones Patológicas, Signos y Síntomas
- Metástasis de neoplasias
- Carcinoma de pulmón de células no pequeñas
- Agentes antineoplásicos inmunológicos
- Inhibidores de puntos de control inmunitarios
- Agentes antineoplásicos
- Mecanismos moleculares de acción farmacológica.
- pembrolizumab
- tislelizumab
Otros números de identificación del estudio
- AdvanTIG-302
- BGB-A317-A1217-302 (Otro identificador: BeiGene)
- CTR20211476/CTR20211464 (Otro identificador: ChinaDrugTrials)
- 2020-004985-21 (Número EudraCT)
- 2023-507317-10-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Marco de tiempo para compartir IPD
See plan description
Criterios de acceso compartido de IPD
See plan description
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
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. .