Um estudo de ociperlimabe com tislelizumabe comparado a pembrolizumabe em participantes com câncer de pulmão não tratado
20 de abril de 2026 atualizado por: BeiGene
Um estudo de fase 3, randomizado, duplo-cego de ociperlimabe, um anticorpo anti-TIGIT, em combinação com tislelizumabe em comparação com pembrolizumabe em pacientes com células não pequenas não tratadas previamente, PD-L1 selecionado e localmente avançado, irressecável ou metastático Câncer de pulmão
O objetivo do estudo é comparar a sobrevida livre de progressão (PFS) entre o Grupo A (ociperlimabe em combinação com tislelizumabe) e o Grupo B (pembrolizumabe em combinação com placebo) conforme avaliado pelos investigadores de acordo com os Critérios de Avaliação de Resposta em Tumores Sólidos Versão 1.1 ( RECIST v1.1) e comparar a sobrevida global (OS) entre o braço A e o braço B.
Visão geral do estudo
Status
Rescindido
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
669
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Aachen, Alemanha, 52074
- Universitaetsklinikum Aachen
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Bonn, Alemanha, 53127
- Universitatsklinikum Bonn
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Cologne, Alemanha, 51109
- Kliniken der Stadt Koeln gGmbH
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Giessen, Alemanha, 35392
- Uniklinikum Giessen Marburg
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Grohansdorf, Alemanha, 22927
- LungenClinic Grosshansdorf GmbH
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Hamburg, Alemanha, 20251
- Ambulantes Krebszentrum Hamburg
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Munich, Alemanha, 81925
- Munchen Klinik Bogenhausen
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Rotenburg (Wümme), Alemanha, 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, Austrália, 2139
- Concord Repatriation General Hospital
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St Leonards, New South Wales, Austrália, 2065
- Northern Cancer Institute
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Waratah, New South Wales, Austrália, 2298
- Calvary Mater Newcastle
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Queensland
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Benowa, Queensland, Austrália, 4217
- Pindara Private Hospital
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Chermside, Queensland, Austrália, 4032
- The Prince Charles Hospital
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South Brisbane, Queensland, Austrália, 4101
- Mater Cancer Care Centre
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Tugun, Queensland, Austrália, 4224
- John Flynn Private Hospital
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South Australia
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Elizabeth Vale, South Australia, Austrália, 5112
- Lyell McEwin Hospital
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Victoria
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Ballarat, Victoria, Austrália, 3350
- Ballarat Health Services
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Clayton, Victoria, Austrália, 3168
- Monash Health
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St Albans, Victoria, Austrália, 3021
- Western Health Sunshine Hospital
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Western Australia
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Murdoch, Western Australia, Austrália, 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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Anhui
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Hefei, Anhui, China, 230601
- The Second Hospital of Anhui Medical University
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Hefei, Anhui, China, 230000
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, China, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, China, 100020
- Beijing Chao Yang Hospital
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Beijing, Beijing Municipality, China, 101149
- Beijing Chest Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400030
- Chongqing Cancer Hospital
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Chongqing, Chongqing Municipality, China, 400042
- Daping Hospital, Third Military Medical University
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Chongqing, Chongqing Municipality, China, 400038
- The First Affiliated Hospital of Army Military Medical University
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Chongqing, Chongqing Municipality, China, 404000
- Chongqing University Three Gorges Central Hospital
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Fujian
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Fuzhou, Fujian, China, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, China, 350014
- Fujian Cancer Hospital
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Xiamen, Fujian, China, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, China, 510030
- Affiliated Cancer Hospital and institute of Guangzhou Medical University
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Shantou, Guangdong, China, 515031
- Cancer Hospital of Shantou University Medical College
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Shenzhen, Guangdong, China, 518020
- Shenzhen Peoples Hospital
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Guangxi
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Nanning, Guangxi, China, 530021
- The Peoples Hospital of Guangxi Zhuang Autonomous Region
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Nanning, Guangxi, China, 530021
- The Tumor Hospital Affiliated to Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, China, 450052
- The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, China, 450000
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, China, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, China, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Hubei, China, 430022
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, China, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, China, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Changzhou, Jiangsu, China, 213003
- Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
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Nanjing, Jiangsu, China, 210029
- Nanjing Chest Hospital
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Nanjing, Jiangsu, China, 210009
- Nanjing First Hospital
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Suzhou, Jiangsu, China, 215000
- The Second Affiliated Hospital of Soochow University
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Suzhou, Jiangsu, China, 215006
- The First Affiliated Hospital of Soochow University Branch Shizi
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Xuzhou, Jiangsu, China, 221000
- Xuzhou Central Hospital
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Liaoning
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Shenyang, Liaoning, China, 110042
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Shandong
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Qingdao, Shandong, China, 266000
- The Affiliated Hospital of Qingdao University Branch Laoshan
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Weifang, Shandong, China, 261000
- Weifang Peoples Hospital
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Yantai, Shandong, China, 264000
- Yantai YuHuangDing Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200433
- Shanghai Pulmonary Hospital
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Shanghai, Shanghai Municipality, China, 200030
- Shanghai Chest Hospital
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Shanghai, Shanghai Municipality, China, 200032
- Affiliated Zhongshan Hospital of Fudan University
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Shanxi
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Taiyuan, Shanxi, China, 030032
- Shanxi Bethune Hospital
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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Chengdu, Sichuan, China, 610041
- Sichuan Cancer Hospital and Institute
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Nanchong, Sichuan, China, 637000
- Affiliated Hospital of North Sichuan Medical College
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Tianjin, Tianjin Municipality, China, 300052
- Tianjin Medical University General Hospital
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Xinjiang
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Ürümqi, Xinjiang, China, 830000
- Affiliated Cancer Hospital of Xinjiang Medical University
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Zhejiang
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Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Ningbo, Zhejiang, China, 315010
- The First Affiliated Hospital of Ningbo University
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Taizhou, Zhejiang, China, 317000
- Taizhou Hospital of Zhejiang
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Yiwu, Zhejiang, China, 322000
- The Fourth Affiliated Hospital Zhejiang University School of Medicine
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Chungcheongbukdo
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Cheongju-si, Chungcheongbukdo, Coréia do Sul, 28644
- Chungbuk National University Hospital
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, Coréia do Sul, 42601
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Coréia do Sul, 14647
- The Catholic University of Korea Bucheon St Marys Hospital
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Gyeonggido, Gyeonggi-do, Coréia do Sul, 13496
- CHA Bundang Medical Center, CHA University
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Suwon, Gyeonggi-do, Coréia do Sul, 16247
- The Catholic University of Korea, St Vincents Hospital
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Gyeongsangbukdo
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Daegu, Gyeongsangbukdo, Coréia do Sul, 41404
- Kyungpook National University Chilgok Hospital
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Seoul Teugbyeolsi
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Eunpyeonggu, Seoul Teugbyeolsi, Coréia do Sul, 03312
- The Catholic University of Korea, Eunpyeong St Marys Hospital
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Seoul, Seoul Teugbyeolsi, Coréia do Sul, 03722
- Severance Hospital Yonsei University Health System
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Alcorcón, Espanha, 28922
- Hospital Universitario Fundacion Alcorcon
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Barcelona, Espanha, 08003
- Hospital Del Mar
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Barcelona, Espanha, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Espanha, 08035
- Hospital Universitario Vall Dhebron
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Barcelona, Espanha, 8028
- Hospital Universitari Quiron Dexeus
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Elche, Espanha, 3203
- Hospital General Universitario de Elche
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Girona, Espanha, 17007
- ICO Girona
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Jaén, Espanha, 23007
- Hospital Universitario de Jaén
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Las Palmas, Espanha, 35016
- Complejo Hospitalario Universitario Insular Gran Canaria
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Lugo, Espanha, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Espanha, 28040
- Hospital Clinico San Carlos
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Madrid, Espanha, 28046
- Hospital Universitario La Paz
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Madrid, Espanha, 28041
- Hospital Universitario Doce de Octubre
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Madrid, Espanha, 28040
- Start Madrid Fundacion Jimenez Diaz
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Majadahonda, Espanha, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Murcia, Espanha, 30008
- Hospital General Universitario Morales Meseguer
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Málaga, Espanha, 29010
- Hospital Regional Universitario de Málaga
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Málaga, Espanha, 29010
- Hospital Universitario Virgen de la Victoria
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Ourense, Espanha, 32005
- Complexo Hospitalario Universitario de Ourense
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Palma de Mallorca, Espanha, 07120
- Hospital Universitari Son Espases
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Seville, Espanha, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Espanha, 41014
- Hospital Universitario Nuestra Señora de Valme
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Valencia, Espanha, 46026
- Hospital Universitari i Politecnic La Fe
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Valencia, Espanha, 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, França, 64100
- Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
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Bordeaux, França, 33076
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, França, 69317
- Hôpital de La Croix Rousse
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Lyon, França, 69500
- Hopital Louis Pradel
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Montpellier, França, 24298
- Icm Val Daurelle Oncologie Medicale
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Nancy, França, 54100
- Polyclinique de Gentilly
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Paris, França, 75014
- Hôpital Cochin
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PierreBenite, França, 69495
- Chu Hopital Lyon Sud
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Saint-Mandé, França, 94160
- HIA Begin
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Saint-Pierre, França, 97448
- CHU de la Réunion
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SaintHerblain, França, 44805
- Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
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SaintHerblain, França, 44805
- CHU Nantes Hopital Nord Laennec
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Tours, França, 37000
- Chu Tours Hopital Bretonneau Service Pneumologie
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Batumi, Geórgia, 6000
- High Technology Hospital MedCenter Ltd
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Tbilisi, Geórgia, 0186
- Multiprofile Clinic Consilium Medulla Ltd
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Tbilisi, Geórgia, 0159
- Institute of Clinical Oncology Ltd
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Tbilisi, Geórgia, 0112
- Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
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Tbilisi, Geórgia, 0112
- Israel Georgian Medical Research Clinic Helsicore Ltd
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Tbilisi, Geórgia, 0119
- Jsc German Hospital
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Tbilisi, Geórgia, 0159
- Jsc Evex Hospitals Tbilisi
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Tbilisi, Geórgia, 0160
- Tim Tbilisi Institute of Medicine Ltd
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Tbilisi, Geórgia, 0186
- Caucasus Medical Centre Ltd
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Tbilisi, Geórgia, 0186
- Oncology Research Center Ltd
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Amersfoort, Holanda, 3813 TZ
- Meander Medisch Centrum
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Arnhem, Holanda, 6815 AD
- Rijnstate
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Harderwijk, Holanda, 3844 DG
- Ziekenhuis St Jansdal
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Heerlen, Holanda, 6419 PC
- Stichting Zuyderland Medisch Centrum
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Zwolle, Holanda, 8025 AB
- Isala Klinieken Zwolle
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Bologna, Itália, 40138
- Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
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Messina, Itália, 98158
- Azienda Ospedaliera Papardo
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Orbassano, Itália, 10043
- AOU San Luigi Gonzaga
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Hiroshima, Japão, 734-8551
- Hiroshima University Hospital
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Niigata, Japão, 951-8566
- Niigata Cancer Center Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japão, 466-8560
- Nagoya University Hospital
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Aomori
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Hirosaki, Aomori, Japão, 036-8563
- Hirosaki University Hospital
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Ehime
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Matsuyama, Ehime, Japão, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka
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Kurume, Fukuoka, Japão, 830-0011
- Kurume University Hospital
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Gunma
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Shibukawa, Gunma, Japão, 337-0280
- National Hospital Organization Shibukawa Medical Center
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Hyōgo
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Kobe, Hyōgo, Japão, 650-0017
- Kobe University Hospital
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Kobe, Hyōgo, Japão, 650-0047
- Kobe City Medical Center General Hospital
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Nishinomiyashi, Hyōgo, Japão, 663-8501
- Hyogo Medical University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japão, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japão, 241-8515
- Kanagawa Cancer Center
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Miyagi
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Natorishi, Miyagi, Japão, 981-1293
- Miyagi Cancer Center
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Okayama-ken
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Okayama, Okayama-ken, Japão, 700-8558
- Okayama University Hospital
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Osaka
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Hirakata, Osaka, Japão, 573-1191
- Kansai Medical University Hospital
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Sakai, Osaka, Japão, 591-8555
- National Hospital Organization Kinki Chuo Chest Medical Center
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Sayama, Osaka, Japão, 589-8511
- Kindai University Hospital
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Toyonaka, Osaka, Japão, 560-8552
- Osaka Toneyama Medical Center
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Tochigi
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Shimonotsuke, Tochigi, Japão, 329-0498
- Jichi Medical University Hospital
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Shimotsugagun, Tochigi, Japão, 321-0293
- Dokkyo Medical University Hospital
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Utsunomiya, Tochigi, Japão, 320-0834
- Tochigi Cancer Center
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Tokyo
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Bunkyoku, Tokyo, Japão, 113-8603
- Nippon Medical School Hospital
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Kotoku, Tokyo, Japão, 135-8550
- Cancer Institute Hospital of JFCR
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Bialystok, Polônia, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Lodz, Polônia, 93-510
- Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lodz, Polônia, 90-338
- Centrum Terapii Wspoczesnej
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Poznan, Polônia, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
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Poznan, Polônia, 60-693
- Przychodnia Med Polonia Sp Z Oo
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Zamość, Polônia, 22-400
- ETG Zamość
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Arkhangelskaya oblast
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Arkhangelsk, Arkhangelskaya oblast, Rússia, 163045
- Arkhangelsk Regional Clinical Oncological Dispensary
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Bashkortostan Republic
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Ufa, Bashkortostan Republic, Rússia, 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, Rússia, 455001
- State Budgetary Healthcare Institution Regional Oncology Dispensary Number
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Moscow
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Moscow, Moscow, Rússia, 121309
- VitaMed LLC
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Nizhny Novgorod Oblast
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Nizhny Novgorod, Nizhny Novgorod Oblast, Rússia, 603081
- State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
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Omsk Oblast
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Omsk, Omsk Oblast, Rússia, 644013
- Bih of Omsk Region Clinical Oncology Dispensary
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Samaraskaya Oblast'
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Samara, Samaraskaya Oblast', Rússia, 443031
- State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Rússia, 197082
- Llc Av Medical Group
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Bangkok, Tailândia, 10700
- Siriraj Hospital
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Hat Yai, Tailândia, 90110
- Songklanagarind Hospital (Prince of Songkhla University)
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Lak Si, Tailândia, 10210
- Chulabhorn Research Institute
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Muang, Tailândia, 50200
- Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
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Muang, Tailândia, 40002
- Srinagarind Hospital (Khon Kaen University)
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Ratchathewi, Tailândia, 10400
- Phramongkutklao Hospital
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Ratchathewi, Tailândia, 10400
- Rajavithi Hospital
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Changhua, Taiwan, 50006
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, Taiwan, 40201
- Chung Shan Medical University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 231405
- Taipei Tzu Chi Hospital
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Taoyuan, Taiwan, 33305
- Linkou Chang Gung Memorial Hospital
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Yunlin, Taiwan, 640
- National Taiwan University Hospital Yunlin Branch
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Adana, Turquia (Türkiye), 01130
- Acibadem Adana Hospital
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Adana, Turquia (Türkiye), 1240
- Baskent University Practice and Research Hospital Adana Medical Oncology Department
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Ankara, Turquia (Türkiye), 6520
- Memorial Ankara Hospital
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Ankara, Turquia (Türkiye), 06200
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Battalgazi, Turquia (Türkiye), 44280
- Inonu Universitesi Tip Fakultesi
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Edirne, Turquia (Türkiye), 22030
- Tr Trakya University Health Research and Application Center (Hospital)
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Istanbul, Turquia (Türkiye), 34098
- Iu C, Clinical Research Excellence Application and Research Center
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Istanbul, Turquia (Türkiye), 34722
- Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
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Izmir, Turquia (Türkiye), 35100
- Ege University Medical Faculty
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Kocaeli, Turquia (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi
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Meram, Turquia (Türkiye), 42090
- Necmettin Erbakan University Selcuklu Faculty of Medicine
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Mersin City Hospital, Turquia (Türkiye), 33240
- Mersin City Hospital
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Kryvyi Rih, Ucrânia, 50000
- Medical Center of Limited Liability Company Mriya Med Service
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Uzhhorod, Ucrânia, 88000
- Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
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Uzhhorod, Ucrânia, 88011
- Zakarpatska Regional Clinical Oncological Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
Principais Critérios de Inclusão:
- Câncer de pulmão de células não pequenas (NSCLC) localmente avançado ou recorrente documentado histológica ou citologicamente que não é elegível para cirurgia curativa e/ou radioterapia definitiva com ou sem quimiorradioterapia, ou NSCLC metastático não escamoso ou escamoso.
- Nenhum tratamento sistêmico prévio para NSCLC metastático.
- Acordo para fornecer tecido de arquivo ou biópsia recente (se o tecido de arquivo não estiver disponível).
- Tumores com PD-L1 expressos em ≥ 50% de células tumorais.
- Pelo menos 1 lesão mensurável conforme definido por RECIST v1.1.
- Status de desempenho ECOG ≤ 1.
Principais Critérios de Exclusão:
- Mutações conhecidas no gene do receptor do fator de crescimento epidérmico (EGFR), oncogene de fusão da quinase do linfoma anaplásico (ALK), BRAF V600E ou ROS1.
- Terapia prévia com uma proteína de morte celular antiprogramada (anti-PD)-1, anti-PD-ligante (L)-1, anti-PD-ligante-2, imunoglobulina anti-célula T e ITIM (anti-TIGIT) domínio, ou qualquer outro anticorpo ou droga especificamente visando a co-estimulação de células T ou vias de ponto de verificação.
- Doença leptomeníngea ativa ou metástase cerebral não controlada e não tratada.
- Doenças autoimunes ativas ou história de doenças autoimunes que podem recidivar.
Observação: outros critérios de inclusão/exclusão definidos pelo protocolo podem ser aplicados
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
Tislelizumabe é um anticorpo monoclonal formulado para injeção intravenosa.
Outros nomes:
Ociperlimabe é um anticorpo monoclonal formulado para injeção intravenosa.
Outros nomes:
|
|
Comparador Ativo: 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.
|
Pembrolizumabe é um anticorpo monoclonal formulado para injeção intravenosa.
Outros nomes:
As infusões de placebo consistirão em uma solução salina normal e estéril.
|
|
Comparador de Placebo: 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.
|
Tislelizumabe é um anticorpo monoclonal formulado para injeção intravenosa.
Outros nomes:
As infusões de placebo consistirão em uma solução salina normal e 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.
|
Tislelizumabe é um anticorpo monoclonal formulado para injeção intravenosa.
Outros nomes:
Ociperlimabe é um anticorpo monoclonal formulado para injeção intravenosa.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS) in Arms A and B
Prazo: 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)
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Prazo: 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
Prazo: 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
|
|
Overall Response Rate (ORR) for Arm A Versus Arm B As Assessed By the Investigator
Prazo: 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
|
|
Overall Response Rate (ORR) for Safety Run-In Substudy As Assessed By the Investigator
Prazo: 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
|
|
Duration Of Response (DOR) for Arm A Versus Arm B As Assessed By the Investigator
Prazo: 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
|
|
Duration Of Response (DOR) for Safety Run-In Substudy As Assessed By the Investigator
Prazo: 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
Prazo: 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
|
|
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
Prazo: 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
|
|
Change From Baseline in European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Visual Analog Scale in Arms A and B
Prazo: 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
|
|
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
Prazo: 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
|
|
Time To Deterioration (TTD) in Arms A and B Based on QLQ-C30 GHS/QoL Score, Physical Functioning, and Fatigue
Prazo: 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
Prazo: 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
Prazo: Up to 38.9 months
|
Up to 38.9 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Mark Socinski, Advent Health Orlando
- Investigador principal: Shun Lu, Shanghai Chest Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
24 de maio de 2021
Conclusão Primária (Real)
30 de maio de 2025
Conclusão do estudo (Real)
18 de março de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
5 de fevereiro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de fevereiro de 2021
Primeira postagem (Real)
10 de fevereiro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
12 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Neoplasias por local
- Neoplasias
- Doenças Respiratórias
- Doenças pulmonares
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Processos Neoplásicos
- Neoplasias Pulmonares
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Condições Patológicas, Sinais e Sintomas
- Neoplasia Metástase
- Carcinoma pulmonar de células não pequenas
- Agentes Antineoplásicos Imunológicos
- Inibidores de Ponto de Verificação Imunológica
- Agentes Antineoplásicos
- Mecanismos Moleculares de Ação Farmacológica
- Pembrolizumab
- tislelizumab
Outros números de identificação do estudo
- AdvanTIG-302
- BGB-A317-A1217-302 (Outro identificador: BeiGene)
- CTR20211476/CTR20211464 (Outro identificador: ChinaDrugTrials)
- 2020-004985-21 (Número EudraCT)
- 2023-507317-10-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
See plan description
Critérios de acesso de compartilhamento IPD
See plan description
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .