En studie av Ociperlimab med Tislelizumab jämfört med Pembrolizumab hos deltagare med obehandlad lungcancer
20 april 2026 uppdaterad av: BeiGene
En fas 3, randomiserad, dubbelblind studie av Ociperlimab, en anti-TIGIT-antikropp, i kombination med Tislelizumab jämfört med Pembrolizumab hos patienter med tidigare obehandlade, PD-L1-selekterade och lokalt avancerade, icke-resekterbara eller metastaserande icke-småcelliga Lungcancer
Syftet med studien är att jämföra progressionsfri överlevnad (PFS) mellan arm A (ociperlimab i kombination med tislelizumab) och arm B (pembrolizumab i kombination med placebo) som bedömts av utredare enligt Response Evaluation Criteria in Solid Tumors Version 1.1 ( RECIST v1.1) och för att jämföra total överlevnad (OS) mellan arm A och arm B.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
669
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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, Australien, 2139
- Concord Repatriation General Hospital
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St Leonards, New South Wales, Australien, 2065
- Northern Cancer Institute
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Waratah, New South Wales, Australien, 2298
- Calvary Mater Newcastle
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Queensland
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Benowa, Queensland, Australien, 4217
- Pindara Private Hospital
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Chermside, Queensland, Australien, 4032
- The Prince Charles Hospital
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South Brisbane, Queensland, Australien, 4101
- Mater Cancer Care Centre
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Tugun, Queensland, Australien, 4224
- John Flynn Private Hospital
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South Australia
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Elizabeth Vale, South Australia, Australien, 5112
- Lyell McEwin Hospital
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Victoria
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Ballarat, Victoria, Australien, 3350
- Ballarat Health Services
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Clayton, Victoria, Australien, 3168
- Monash Health
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St Albans, Victoria, Australien, 3021
- Western Health Sunshine Hospital
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Western Australia
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Murdoch, Western Australia, Australien, 6150
- St John of God, Murdoch
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Brasília, Brasilien, 70390140
- Instituto Dor de Pesquisa E Ensino Distrito Federal
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Cachoeiro de Itapemirim, Brasilien, 29308-020
- Hospital Evangélico de Cachoeiro de Itapemirim
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Florianópolis, Brasilien, 88034-000
- Centro de Pesquisas Oncologicas Cepon
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Fortaleza, Brasilien, 60430-235
- Cancer Institute of Ceara
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Santo André, Brasilien, 09060-650
- Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
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São José do Rio Preto, Brasilien, 15090-000
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
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Bayonne, Frankrike, 64100
- Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
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Bordeaux, Frankrike, 33076
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, Frankrike, 69317
- Hôpital de La Croix Rousse
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Lyon, Frankrike, 69500
- Hopital Louis Pradel
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Montpellier, Frankrike, 24298
- Icm Val Daurelle Oncologie Medicale
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Nancy, Frankrike, 54100
- Polyclinique de Gentilly
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Paris, Frankrike, 75014
- Hôpital Cochin
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PierreBenite, Frankrike, 69495
- Chu Hopital Lyon Sud
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Saint-Mandé, Frankrike, 94160
- HIA Begin
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Saint-Pierre, Frankrike, 97448
- CHU de la Réunion
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SaintHerblain, Frankrike, 44805
- Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
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SaintHerblain, Frankrike, 44805
- CHU Nantes Hopital Nord Laennec
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Tours, Frankrike, 37000
- Chu Tours Hopital Bretonneau Service Pneumologie
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California
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Fullerton, California, Förenta staterna, 92835
- Providence Medical Foundation St Jude Heritage Healthcare
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Los Angeles, California, Förenta staterna, 90067
- Valkyrie Clinical Trials
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Florida
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Ocala, Florida, Förenta staterna, 34474
- Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
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Orlando, Florida, Förenta staterna, 32804
- Advent Health Cancer Institute
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Indiana
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Goshen, Indiana, Förenta staterna, 46526
- Goshen Center for Cancer Care
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40503
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- University Medical Center New Orleans West Jefferson Medical Center
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Minnesota
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Saint Paul, Minnesota, Förenta staterna, 55101
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15224
- West Penn Hospital
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Batumi, Georgien, 6000
- High Technology Hospital MedCenter Ltd
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Tbilisi, Georgien, 0186
- Multiprofile Clinic Consilium Medulla Ltd
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Tbilisi, Georgien, 0159
- Institute of Clinical Oncology Ltd
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Tbilisi, Georgien, 0112
- Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
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Tbilisi, Georgien, 0112
- Israel Georgian Medical Research Clinic Helsicore Ltd
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Tbilisi, Georgien, 0119
- Jsc German Hospital
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Tbilisi, Georgien, 0159
- Jsc Evex Hospitals Tbilisi
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Tbilisi, Georgien, 0160
- Tim Tbilisi Institute of Medicine Ltd
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Tbilisi, Georgien, 0186
- Caucasus Medical Centre Ltd
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Tbilisi, Georgien, 0186
- Oncology Research Center Ltd
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Bologna, Italien, 40138
- Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
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Messina, Italien, 98158
- Azienda Ospedaliera Papardo
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Orbassano, Italien, 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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Anhui
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Hefei, Anhui, Kina, 230601
- The Second Hospital of Anhui Medical University
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Hefei, Anhui, Kina, 230000
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Kina, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, Kina, 100020
- Beijing Chao Yang Hospital
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Beijing, Beijing Municipality, Kina, 101149
- Beijing Chest Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400030
- Chongqing Cancer Hospital
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Chongqing, Chongqing Municipality, Kina, 400042
- Daping Hospital, Third Military Medical University
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Chongqing, Chongqing Municipality, Kina, 400038
- The First Affiliated Hospital of Army Military Medical University
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Chongqing, Chongqing Municipality, Kina, 404000
- Chongqing University Three Gorges Central Hospital
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Fujian
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Fuzhou, Fujian, Kina, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, Kina, 350014
- Fujian Cancer Hospital
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Xiamen, Fujian, Kina, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Kina, 510030
- Affiliated Cancer Hospital and institute of Guangzhou Medical University
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Shantou, Guangdong, Kina, 515031
- Cancer Hospital of Shantou University Medical College
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Shenzhen, Guangdong, Kina, 518020
- Shenzhen Peoples Hospital
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Guangxi
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Nanning, Guangxi, Kina, 530021
- The Peoples Hospital of Guangxi Zhuang Autonomous Region
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Nanning, Guangxi, Kina, 530021
- The Tumor Hospital Affiliated to Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150000
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Kina, 450052
- The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, Kina, 450000
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, Kina, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, Kina, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Hubei, Kina, 430022
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Kina, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, Kina, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Changzhou, Jiangsu, Kina, 213003
- Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
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Nanjing, Jiangsu, Kina, 210029
- Nanjing Chest Hospital
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Nanjing, Jiangsu, Kina, 210009
- Nanjing First Hospital
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Suzhou, Jiangsu, Kina, 215000
- The Second Affiliated Hospital of Soochow University
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Suzhou, Jiangsu, Kina, 215006
- The First Affiliated Hospital of Soochow University Branch Shizi
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Xuzhou, Jiangsu, Kina, 221000
- Xuzhou Central Hospital
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Liaoning
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Shenyang, Liaoning, Kina, 110042
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, Kina, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Shandong
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Qingdao, Shandong, Kina, 266000
- The Affiliated Hospital of Qingdao University Branch Laoshan
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Weifang, Shandong, Kina, 261000
- Weifang Peoples Hospital
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Yantai, Shandong, Kina, 264000
- Yantai YuHuangDing Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200433
- Shanghai Pulmonary Hospital
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Shanghai, Shanghai Municipality, Kina, 200030
- Shanghai Chest Hospital
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Shanghai, Shanghai Municipality, Kina, 200032
- Affiliated Zhongshan Hospital of Fudan University
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Shanxi
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Taiyuan, Shanxi, Kina, 030032
- Shanxi Bethune Hospital
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital, Sichuan University
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Chengdu, Sichuan, Kina, 610041
- Sichuan Cancer Hospital and Institute
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Nanchong, Sichuan, Kina, 637000
- Affiliated Hospital of North Sichuan Medical College
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Tianjin, Tianjin Municipality, Kina, 300052
- Tianjin Medical University General Hospital
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Xinjiang
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Ürümqi, Xinjiang, Kina, 830000
- Affiliated Cancer Hospital of Xinjiang Medical University
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Kina, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Ningbo, Zhejiang, Kina, 315010
- The First Affiliated Hospital of Ningbo University
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Taizhou, Zhejiang, Kina, 317000
- Taizhou Hospital of Zhejiang
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Yiwu, Zhejiang, Kina, 322000
- The Fourth Affiliated Hospital Zhejiang University School of Medicine
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Amersfoort, Nederländerna, 3813 TZ
- Meander Medisch Centrum
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Arnhem, Nederländerna, 6815 AD
- Rijnstate
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Harderwijk, Nederländerna, 3844 DG
- Ziekenhuis St Jansdal
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Heerlen, Nederländerna, 6419 PC
- Stichting Zuyderland Medisch Centrum
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Zwolle, Nederländerna, 8025 AB
- Isala Klinieken Zwolle
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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, Ryssland, 163045
- Arkhangelsk Regional Clinical Oncological Dispensary
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Bashkortostan Republic
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Ufa, Bashkortostan Republic, Ryssland, 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, Ryssland, 455001
- State Budgetary Healthcare Institution Regional Oncology Dispensary Number
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Moscow
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Moscow, Moscow, Ryssland, 121309
- VitaMed LLC
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Nizhny Novgorod Oblast
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Nizhny Novgorod, Nizhny Novgorod Oblast, Ryssland, 603081
- State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
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Omsk Oblast
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Omsk, Omsk Oblast, Ryssland, 644013
- Bih of Omsk Region Clinical Oncology Dispensary
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Samaraskaya Oblast'
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Samara, Samaraskaya Oblast', Ryssland, 443031
- State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Ryssland, 197082
- Llc Av Medical Group
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Alcorcón, Spanien, 28922
- Hospital Universitario Fundacion Alcorcon
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Barcelona, Spanien, 08003
- Hospital Del Mar
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Barcelona, Spanien, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Spanien, 08035
- Hospital Universitario Vall Dhebron
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Barcelona, Spanien, 8028
- Hospital Universitari Quiron Dexeus
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Elche, Spanien, 3203
- Hospital General Universitario de Elche
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Girona, Spanien, 17007
- ICO Girona
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Jaén, Spanien, 23007
- Hospital Universitario de Jaén
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Las Palmas, Spanien, 35016
- Complejo Hospitalario Universitario Insular Gran Canaria
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Lugo, Spanien, 27003
- Hospital Universitario Lucus Augusti
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Madrid, Spanien, 28040
- Hospital Clinico San Carlos
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Madrid, Spanien, 28041
- Hospital Universitario Doce de Octubre
-
Madrid, Spanien, 28040
- Start Madrid Fundacion Jimenez Diaz
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Majadahonda, Spanien, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Murcia, Spanien, 30008
- Hospital General Universitario Morales Meseguer
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Málaga, Spanien, 29010
- Hospital Regional Universitario de Málaga
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Málaga, Spanien, 29010
- Hospital Universitario Virgen de la Victoria
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Ourense, Spanien, 32005
- Complexo Hospitalario Universitario de Ourense
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Palma de Mallorca, Spanien, 07120
- Hospital Universitari Son Espases
-
Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Spanien, 41014
- Hospital Universitario Nuestra Señora de Valme
-
Valencia, Spanien, 46026
- Hospital Universitari i Politecnic La Fe
-
Valencia, Spanien, 46015
- Hospital Arnau de Vilanova
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Chungcheongbukdo
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Cheongju-si, Chungcheongbukdo, Sydkorea, 28644
- Chungbuk National University Hospital
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, Sydkorea, 42601
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, Sydkorea, 14647
- The Catholic University of Korea Bucheon St Marys Hospital
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Gyeonggido, Gyeonggi-do, Sydkorea, 13496
- CHA Bundang Medical Center, CHA University
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Suwon, Gyeonggi-do, Sydkorea, 16247
- The Catholic University of Korea, St Vincents Hospital
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Gyeongsangbukdo
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Daegu, Gyeongsangbukdo, Sydkorea, 41404
- Kyungpook National University Chilgok Hospital
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Seoul Teugbyeolsi
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Eunpyeonggu, Seoul Teugbyeolsi, Sydkorea, 03312
- The Catholic University of Korea, Eunpyeong St Marys Hospital
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Seoul, Seoul Teugbyeolsi, Sydkorea, 03722
- Severance Hospital Yonsei University Health System
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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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-
-
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Adana, Turkiet (Türkiye), 01130
- Acibadem Adana Hospital
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Adana, Turkiet (Türkiye), 1240
- Baskent University Practice and Research Hospital Adana Medical Oncology Department
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Ankara, Turkiet (Türkiye), 6520
- Memorial Ankara Hospital
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Ankara, Turkiet (Türkiye), 06200
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Battalgazi, Turkiet (Türkiye), 44280
- Inonu Universitesi Tip Fakultesi
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Edirne, Turkiet (Türkiye), 22030
- Tr Trakya University Health Research and Application Center (Hospital)
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Istanbul, Turkiet (Türkiye), 34098
- Iu C, Clinical Research Excellence Application and Research Center
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Istanbul, Turkiet (Türkiye), 34722
- Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
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Izmir, Turkiet (Türkiye), 35100
- Ege University Medical Faculty
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Kocaeli, Turkiet (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi
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Meram, Turkiet (Türkiye), 42090
- Necmettin Erbakan University Selcuklu Faculty of Medicine
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Mersin City Hospital, Turkiet (Türkiye), 33240
- Mersin City Hospital
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Aachen, Tyskland, 52074
- Universitaetsklinikum Aachen
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Bonn, Tyskland, 53127
- Universitatsklinikum Bonn
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Cologne, Tyskland, 51109
- Kliniken der Stadt Koeln gGmbH
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Giessen, Tyskland, 35392
- Uniklinikum Giessen Marburg
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Grohansdorf, Tyskland, 22927
- LungenClinic Grosshansdorf GmbH
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Hamburg, Tyskland, 20251
- Ambulantes Krebszentrum Hamburg
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Munich, Tyskland, 81925
- Munchen Klinik Bogenhausen
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Rotenburg (Wümme), Tyskland, 27356
- Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
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Kryvyi Rih, Ukraina, 50000
- Medical Center of Limited Liability Company Mriya Med Service
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Uzhhorod, Ukraina, 88000
- Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
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Uzhhorod, Ukraina, 88011
- Zakarpatska Regional Clinical Oncological Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Beskrivning
Viktiga inkluderingskriterier:
- Histologiskt eller cytologiskt dokumenterad lokalt avancerad eller återkommande icke-småcellig lungcancer (NSCLC) som inte är kvalificerad för botande kirurgi och/eller definitiv strålbehandling med eller utan kemoradioterapi, eller metastaserande icke-småcellig eller skivepitelcancer.
- Ingen tidigare systemisk behandling för metastaserande NSCLC.
- Överenskommelse om att tillhandahålla arkivvävnad eller färsk biopsi (om arkivvävnad inte är tillgänglig).
- Tumörer med PD-L1 uttryckt i ≥ 50 % tumörceller.
- Minst 1 mätbar lesion enligt definitionen i RECIST v1.1.
- ECOG-prestandastatus ≤ 1.
Viktiga uteslutningskriterier:
- Kända mutationer i genen för epidermal tillväxtfaktorreceptor (EGFR), anaplastiskt lymfomkinas (ALK) fusionsonkogen, BRAF V600E eller ROS1.
- Tidigare terapi med ett anti-programmerat celldödsprotein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin och ITIM (anti-TIGIT) domän, eller någon annan antikropp eller läkemedel som specifikt inriktar sig på T-cellssamstimulering eller checkpoint-vägar.
- Aktiv leptomeningeal sjukdom eller okontrollerad, obehandlad hjärnmetastas.
- Aktiva autoimmuna sjukdomar eller historia av autoimmuna sjukdomar som kan återfalla.
Obs: Andra protokolldefinierade kriterier för inkludering/uteslutning kan gälla
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 är en monoklonal antikropp formulerad för intravenös injektion.
Andra namn:
Ociperlimab är en monoklonal antikropp formulerad för intravenös injektion.
Andra namn:
|
|
Aktiv komparator: 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 är en monoklonal antikropp formulerad för intravenös injektion.
Andra namn:
Placeboinfusioner kommer att bestå av en steril, normal koksaltlösning.
|
|
Placebo-jämförare: 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 är en monoklonal antikropp formulerad för intravenös injektion.
Andra namn:
Placeboinfusioner kommer att bestå av en steril, normal koksaltlösning.
|
|
Experimentell: 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 är en monoklonal antikropp formulerad för intravenös injektion.
Andra namn:
Ociperlimab är en monoklonal antikropp formulerad för intravenös injektion.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS) in Arms A and B
Tidsram: 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)
Tidsram: 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
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 38.9 months
|
Up to 38.9 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Mark Socinski, Advent Health Orlando
- Huvudutredare: Shun Lu, Shanghai Chest Hospital
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
24 maj 2021
Primärt slutförande (Faktisk)
30 maj 2025
Avslutad studie (Faktisk)
18 mars 2026
Studieregistreringsdatum
Först inskickad
5 februari 2021
Först inskickad som uppfyllde QC-kriterierna
5 februari 2021
Första postat (Faktisk)
10 februari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 april 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Neoplastiska processer
- Lungneoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Patologiska tillstånd, tecken och symtom
- Neoplasma Metastas
- Karcinom, icke-småcellig lunga
- Antineoplastiska medel, immunologiska
- Immune Checkpoint-hämmare
- Antineoplastiska medel
- Molekylära mekanismer för farmakologisk verkan
- pembrolizumab
- tislelizumab
Andra studie-ID-nummer
- AdvanTIG-302
- BGB-A317-A1217-302 (Annan identifierare: BeiGene)
- CTR20211476/CTR20211464 (Annan identifierare: ChinaDrugTrials)
- 2020-004985-21 (EudraCT-nummer)
- 2023-507317-10-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Tidsram för IPD-delning
See plan description
Kriterier för IPD Sharing Access
See plan description
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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