Een studie van Ociperlimab met Tislelizumab in vergelijking met Pembrolizumab bij deelnemers met onbehandelde longkanker
20 april 2026 bijgewerkt door: BeiGene
Een gerandomiseerde, dubbelblinde fase 3-studie van Ociperlimab, een anti-TIGIT-antilichaam, in combinatie met Tislelizumab in vergelijking met pembrolizumab bij patiënten met niet eerder behandeld, PD-L1-geselecteerd en lokaal gevorderd, inoperabel of gemetastaseerd niet-kleincellig Longkanker
Het doel van de studie is om progressievrije overleving (PFS) te vergelijken tussen arm A (ociperlimab in combinatie met tislelizumab) en arm B (pembrolizumab in combinatie met placebo) zoals beoordeeld door onderzoekers volgens de Response Evaluation Criteria in Solid Tumors versie 1.1 ( RECIST v1.1) en om de totale overleving (OS) tussen arm A en arm B te vergelijken.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
669
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Buenos Aires, Argentinië, 1409
- Centro Medical Austral
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San Miguel de Tucumán, Argentinië, 4000
- Centro Para La Atencion Del Paciente Oncologico (Caipo)
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New South Wales
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Concord, New South Wales, Australië, 2139
- Concord Repatriation General Hospital
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St Leonards, New South Wales, Australië, 2065
- Northern Cancer Institute
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Waratah, New South Wales, Australië, 2298
- Calvary Mater Newcastle
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Queensland
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Benowa, Queensland, Australië, 4217
- Pindara Private Hospital
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Chermside, Queensland, Australië, 4032
- The Prince Charles Hospital
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South Brisbane, Queensland, Australië, 4101
- Mater Cancer Care Centre
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Tugun, Queensland, Australië, 4224
- John Flynn Private Hospital
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South Australia
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Elizabeth Vale, South Australia, Australië, 5112
- Lyell McEwin Hospital
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Victoria
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Ballarat, Victoria, Australië, 3350
- Ballarat Health Services
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Clayton, Victoria, Australië, 3168
- Monash Health
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St Albans, Victoria, Australië, 3021
- Western Health Sunshine Hospital
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Western Australia
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Murdoch, Western Australia, Australië, 6150
- St John of God, Murdoch
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Brasília, Brazilië, 70390140
- Instituto Dor de Pesquisa E Ensino Distrito Federal
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Cachoeiro de Itapemirim, Brazilië, 29308-020
- Hospital Evangélico de Cachoeiro de Itapemirim
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Florianópolis, Brazilië, 88034-000
- Centro de Pesquisas Oncologicas Cepon
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Fortaleza, Brazilië, 60430-235
- Cancer Institute of Ceara
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Santo André, Brazilië, 09060-650
- Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
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São José do Rio Preto, Brazilië, 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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Aachen, Duitsland, 52074
- Universitaetsklinikum Aachen
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Bonn, Duitsland, 53127
- Universitatsklinikum Bonn
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Cologne, Duitsland, 51109
- Kliniken der Stadt Koeln gGmbH
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Giessen, Duitsland, 35392
- Uniklinikum Giessen Marburg
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Grohansdorf, Duitsland, 22927
- LungenClinic Grosshansdorf GmbH
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Hamburg, Duitsland, 20251
- Ambulantes Krebszentrum Hamburg
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Munich, Duitsland, 81925
- Munchen Klinik Bogenhausen
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Rotenburg (Wümme), Duitsland, 27356
- Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
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Bayonne, Frankrijk, 64100
- Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
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Bordeaux, Frankrijk, 33076
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, Frankrijk, 69317
- Hôpital de La Croix Rousse
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Lyon, Frankrijk, 69500
- Hopital Louis Pradel
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Montpellier, Frankrijk, 24298
- Icm Val Daurelle Oncologie Medicale
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Nancy, Frankrijk, 54100
- Polyclinique de Gentilly
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Paris, Frankrijk, 75014
- Hôpital Cochin
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PierreBenite, Frankrijk, 69495
- Chu Hopital Lyon Sud
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Saint-Mandé, Frankrijk, 94160
- HIA Begin
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Saint-Pierre, Frankrijk, 97448
- CHU de la Réunion
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SaintHerblain, Frankrijk, 44805
- Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
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SaintHerblain, Frankrijk, 44805
- CHU Nantes Hopital Nord Laennec
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Tours, Frankrijk, 37000
- Chu Tours Hopital Bretonneau Service Pneumologie
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Batumi, Georgië, 6000
- High Technology Hospital MedCenter Ltd
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Tbilisi, Georgië, 0186
- Multiprofile Clinic Consilium Medulla Ltd
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Tbilisi, Georgië, 0159
- Institute of Clinical Oncology Ltd
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Tbilisi, Georgië, 0112
- Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
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Tbilisi, Georgië, 0112
- Israel Georgian Medical Research Clinic Helsicore Ltd
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Tbilisi, Georgië, 0119
- Jsc German Hospital
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Tbilisi, Georgië, 0159
- Jsc Evex Hospitals Tbilisi
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Tbilisi, Georgië, 0160
- Tim Tbilisi Institute of Medicine Ltd
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Tbilisi, Georgië, 0186
- Caucasus Medical Centre Ltd
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Tbilisi, Georgië, 0186
- Oncology Research Center Ltd
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Bologna, Italië, 40138
- Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
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Messina, Italië, 98158
- Azienda Ospedaliera Papardo
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Orbassano, Italië, 10043
- AOU San Luigi Gonzaga
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Niigata, Japan, 951-8566
- Niigata Cancer Center Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 466-8560
- Nagoya University Hospital
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Aomori
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Hirosaki, Aomori, Japan, 036-8563
- Hirosaki University Hospital
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Ehime
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Matsuyama, Ehime, Japan, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
- Kurume University Hospital
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Gunma
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Shibukawa, Gunma, Japan, 337-0280
- National Hospital Organization Shibukawa Medical Center
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0017
- Kobe University Hospital
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Kobe, Hyōgo, Japan, 650-0047
- Kobe City Medical Center General Hospital
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Nishinomiyashi, Hyōgo, Japan, 663-8501
- Hyogo Medical University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, Japan, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
- Kanagawa Cancer Center
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Miyagi
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Natorishi, Miyagi, Japan, 981-1293
- Miyagi Cancer Center
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Okayama-ken
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Okayama, Okayama-ken, Japan, 700-8558
- Okayama University Hospital
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Osaka
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Hirakata, Osaka, Japan, 573-1191
- Kansai Medical University Hospital
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Sakai, Osaka, Japan, 591-8555
- National Hospital Organization Kinki Chuo Chest Medical Center
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Sayama, Osaka, Japan, 589-8511
- Kindai University Hospital
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Toyonaka, Osaka, Japan, 560-8552
- Osaka Toneyama Medical Center
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Tochigi
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Shimonotsuke, Tochigi, Japan, 329-0498
- Jichi Medical University Hospital
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Shimotsugagun, Tochigi, Japan, 321-0293
- Dokkyo Medical University Hospital
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Utsunomiya, Tochigi, Japan, 320-0834
- Tochigi Cancer Center
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Tokyo
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Bunkyoku, Tokyo, Japan, 113-8603
- Nippon Medical School Hospital
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Kotoku, Tokyo, Japan, 135-8550
- Cancer Institute Hospital of JFCR
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Amersfoort, Nederland, 3813 TZ
- Meander Medisch Centrum
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Arnhem, Nederland, 6815 AD
- Rijnstate
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Harderwijk, Nederland, 3844 DG
- Ziekenhuis St Jansdal
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Heerlen, Nederland, 6419 PC
- Stichting Zuyderland Medisch Centrum
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Zwolle, Nederland, 8025 AB
- Isala Klinieken Zwolle
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Kryvyi Rih, Oekraïne, 50000
- Medical Center of Limited Liability Company Mriya Med Service
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Uzhhorod, Oekraïne, 88000
- Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
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Uzhhorod, Oekraïne, 88011
- Zakarpatska Regional Clinical Oncological Center
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Bialystok, Polen, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Lodz, Polen, 93-510
- Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lodz, Polen, 90-338
- Centrum Terapii Wspoczesnej
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Poznan, Polen, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
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Poznan, Polen, 60-693
- Przychodnia Med Polonia Sp Z Oo
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Zamość, Polen, 22-400
- ETG Zamość
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Arkhangelskaya oblast
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Arkhangelsk, Arkhangelskaya oblast, Rusland, 163045
- Arkhangelsk Regional Clinical Oncological Dispensary
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Bashkortostan Republic
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Ufa, Bashkortostan Republic, Rusland, 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, Rusland, 455001
- State Budgetary Healthcare Institution Regional Oncology Dispensary Number
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Moscow
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Moscow, Moscow, Rusland, 121309
- VitaMed LLC
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Nizhny Novgorod Oblast
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Nizhny Novgorod, Nizhny Novgorod Oblast, Rusland, 603081
- State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
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Omsk Oblast
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Omsk, Omsk Oblast, Rusland, 644013
- Bih of Omsk Region Clinical Oncology Dispensary
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Samaraskaya Oblast'
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Samara, Samaraskaya Oblast', Rusland, 443031
- State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Rusland, 197082
- Llc Av Medical Group
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Alcorcón, Spanje, 28922
- Hospital Universitario Fundacion Alcorcon
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Barcelona, Spanje, 08003
- Hospital Del Mar
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Barcelona, Spanje, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Spanje, 08035
- Hospital Universitario Vall Dhebron
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Barcelona, Spanje, 8028
- Hospital Universitari Quiron Dexeus
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Elche, Spanje, 3203
- Hospital General Universitario de Elche
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Girona, Spanje, 17007
- ICO Girona
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Jaén, Spanje, 23007
- Hospital Universitario de Jaén
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Las Palmas, Spanje, 35016
- Complejo Hospitalario Universitario Insular Gran Canaria
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Lugo, Spanje, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Spanje, 28040
- Hospital Clinico San Carlos
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Madrid, Spanje, 28046
- Hospital Universitario La Paz
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Madrid, Spanje, 28041
- Hospital Universitario Doce de Octubre
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Madrid, Spanje, 28040
- Start Madrid Fundacion Jimenez Diaz
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Majadahonda, Spanje, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Murcia, Spanje, 30008
- Hospital General Universitario Morales Meseguer
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Málaga, Spanje, 29010
- Hospital Regional Universitario de Málaga
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Málaga, Spanje, 29010
- Hospital Universitario Virgen de la Victoria
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Ourense, Spanje, 32005
- Complexo Hospitalario Universitario de Ourense
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Palma de Mallorca, Spanje, 07120
- Hospital Universitari Son Espases
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Seville, Spanje, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Spanje, 41014
- Hospital Universitario Nuestra Señora de Valme
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Valencia, Spanje, 46026
- Hospital Universitari i Politecnic La Fe
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Valencia, Spanje, 46015
- Hospital Arnau de Vilanova
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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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Bangkok, Thailand, 10700
- Siriraj Hospital
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Hat Yai, Thailand, 90110
- Songklanagarind Hospital (Prince of Songkhla University)
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Lak Si, Thailand, 10210
- Chulabhorn Research Institute
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Muang, Thailand, 50200
- Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
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Muang, Thailand, 40002
- Srinagarind Hospital (Khon Kaen University)
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Ratchathewi, Thailand, 10400
- Phramongkutklao Hospital
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Ratchathewi, Thailand, 10400
- Rajavithi Hospital
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Adana, Turkije (Türkiye), 01130
- Acibadem Adana Hospital
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Adana, Turkije (Türkiye), 1240
- Baskent University Practice and Research Hospital Adana Medical Oncology Department
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Ankara, Turkije (Türkiye), 6520
- Memorial Ankara Hospital
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Ankara, Turkije (Türkiye), 06200
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Battalgazi, Turkije (Türkiye), 44280
- Inonu Universitesi Tip Fakultesi
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Edirne, Turkije (Türkiye), 22030
- Tr Trakya University Health Research and Application Center (Hospital)
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Istanbul, Turkije (Türkiye), 34098
- Iu C, Clinical Research Excellence Application and Research Center
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Istanbul, Turkije (Türkiye), 34722
- Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
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Izmir, Turkije (Türkiye), 35100
- Ege University Medical Faculty
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Kocaeli, Turkije (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi
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Meram, Turkije (Türkiye), 42090
- Necmettin Erbakan University Selcuklu Faculty of Medicine
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Mersin City Hospital, Turkije (Türkiye), 33240
- Mersin City Hospital
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California
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Fullerton, California, Verenigde Staten, 92835
- Providence Medical Foundation St Jude Heritage Healthcare
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Los Angeles, California, Verenigde Staten, 90067
- Valkyrie Clinical Trials
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Florida
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Ocala, Florida, Verenigde Staten, 34474
- Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
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Orlando, Florida, Verenigde Staten, 32804
- Advent Health Cancer Institute
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Indiana
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Goshen, Indiana, Verenigde Staten, 46526
- Goshen Center for Cancer Care
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40503
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, Verenigde Staten, 70112
- University Medical Center New Orleans West Jefferson Medical Center
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Minnesota
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Saint Paul, Minnesota, Verenigde Staten, 55101
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15224
- West Penn Hospital
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Chungcheongbukdo
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Cheongju-si, Chungcheongbukdo, Zuid -Korea, 28644
- Chungbuk National University Hospital
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, Zuid -Korea, 42601
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Zuid -Korea, 14647
- The Catholic University of Korea Bucheon St Marys Hospital
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Gyeonggido, Gyeonggi-do, Zuid -Korea, 13496
- CHA Bundang Medical Center, CHA University
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Suwon, Gyeonggi-do, Zuid -Korea, 16247
- The Catholic University of Korea, St Vincents Hospital
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Gyeongsangbukdo
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Daegu, Gyeongsangbukdo, Zuid -Korea, 41404
- Kyungpook National University Chilgok Hospital
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Seoul Teugbyeolsi
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Eunpyeonggu, Seoul Teugbyeolsi, Zuid -Korea, 03312
- The Catholic University of Korea, Eunpyeong St Marys Hospital
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Seoul, Seoul Teugbyeolsi, Zuid -Korea, 03722
- Severance Hospital Yonsei University Health System
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Belangrijkste opnamecriteria:
- Histologisch of cytologisch gedocumenteerd lokaal gevorderd of recidiverend niet-kleincellig longcarcinoom (NSCLC) dat niet in aanmerking komt voor curatieve chirurgie en/of definitieve radiotherapie met of zonder chemoradiotherapie, of gemetastaseerd niet-squameus of squameus NSCLC.
- Geen eerdere systemische behandeling voor gemetastaseerd NSCLC.
- Overeenkomst om archiefmateriaal of verse biopsie te verstrekken (indien archiefmateriaal niet beschikbaar is).
- Tumoren met PD-L1 uitgedrukt in ≥ 50% tumorcellen.
- Ten minste 1 meetbare laesie zoals gedefinieerd in RECIST v1.1.
- ECOG-prestatiestatus ≤ 1.
Belangrijkste uitsluitingscriteria:
- Bekende mutaties in het epidermale groeifactorreceptor (EGFR)-gen, anaplastisch lymfoomkinase (ALK)-fusie-oncogen, BRAF V600E of ROS1.
- Voorafgaande therapie met een anti-geprogrammeerd celdood-eiwit (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cel immunoglobuline en ITIM (anti-TIGIT) domein, of enig ander antilichaam of geneesmiddel dat specifiek gericht is op T-cel co-stimulatie of controlepuntroutes.
- Actieve leptomeningeale ziekte of ongecontroleerde, onbehandelde hersenmetastase.
- Actieve auto-immuunziekten of voorgeschiedenis van auto-immuunziekten die kunnen terugvallen.
Opmerking: er kunnen andere in het protocol gedefinieerde opname-/uitsluitingscriteria van toepassing zijn
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 is een monoklonaal antilichaam geformuleerd voor intraveneuze injectie.
Andere namen:
Ociperlimab is een monoklonaal antilichaam geformuleerd voor intraveneuze injectie.
Andere namen:
|
|
Actieve vergelijker: 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 is een monoklonaal antilichaam geformuleerd voor intraveneuze injectie.
Andere namen:
Placebo-infusies zullen bestaan uit een steriele, normale zoutoplossing.
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Placebo-vergelijker: 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 is een monoklonaal antilichaam geformuleerd voor intraveneuze injectie.
Andere namen:
Placebo-infusies zullen bestaan uit een steriele, normale zoutoplossing.
|
|
Experimenteel: 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 is een monoklonaal antilichaam geformuleerd voor intraveneuze injectie.
Andere namen:
Ociperlimab is een monoklonaal antilichaam geformuleerd voor intraveneuze injectie.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival (OS) in Arms A and B
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 38.9 months
|
Up to 38.9 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Mark Socinski, Advent Health Orlando
- Hoofdonderzoeker: Shun Lu, Shanghai Chest Hospital
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
24 mei 2021
Primaire voltooiing (Werkelijk)
30 mei 2025
Studie voltooiing (Werkelijk)
18 maart 2026
Studieregistratiedata
Eerst ingediend
5 februari 2021
Eerst ingediend dat voldeed aan de QC-criteria
5 februari 2021
Eerst geplaatst (Werkelijk)
10 februari 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
20 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Neoplasmata per site
- Neoplasmata
- Ziekten van de luchtwegen
- Longziekten
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Neoplastische processen
- Longneoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Pathologische aandoeningen, tekenen en symptomen
- Neoplasma metastase
- Carcinoom, niet-kleincellige long
- Antineoplastische middelen, immunologisch
- Immuun Checkpoint-remmers
- Antineoplastische middelen
- Moleculaire mechanismen van farmacologische werking
- pembrolizumab
- tislelizumab
Andere studie-ID-nummers
- AdvanTIG-302
- BGB-A317-A1217-302 (Andere identificatie: BeiGene)
- CTR20211476/CTR20211464 (Andere identificatie: ChinaDrugTrials)
- 2020-004985-21 (EudraCT-nummer)
- 2023-507317-10-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
See plan description
IPD-toegangscriteria voor delen
See plan description
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .