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En undersøgelse af Ociperlimab med Tislelizumab sammenlignet med Pembrolizumab hos deltagere med ubehandlet lungekræft

20. april 2026 opdateret af: BeiGene

Et fase 3, randomiseret, dobbeltblindt studie af Ociperlimab, et anti-TIGIT-antistof, i kombination med Tislelizumab sammenlignet med Pembrolizumab hos patienter med tidligere ubehandlede, PD-L1-selekterede og lokalt avancerede, uoperable eller metastatiske ikke-småcellede Lungekræft

Formålet med undersøgelsen er at sammenligne progressionsfri overlevelse (PFS) mellem arm A (ociperlimab i kombination med tislelizumab) og arm B (pembrolizumab i kombination med placebo) som vurderet af efterforskere i henhold til responsevalueringskriterier i solide tumorer Version 1.1 ( RECIST v1.1) og for at sammenligne overordnet overlevelse (OS) mellem arm A og arm B.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

669

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1409
        • Centro Medical Austral
      • San Miguel de Tucumán, Argentina, 4000
        • Centro Para La Atencion Del Paciente Oncologico (Caipo)
  • Australien
    • New South Wales
      • Concord, New South Wales, Australien, 2139
        • Concord Repatriation General Hospital
      • St Leonards, New South Wales, Australien, 2065
        • Northern Cancer Institute
      • Waratah, New South Wales, Australien, 2298
        • Calvary Mater Newcastle
    • Queensland
      • Benowa, Queensland, Australien, 4217
        • Pindara Private Hospital
      • Chermside, Queensland, Australien, 4032
        • The Prince Charles Hospital
      • South Brisbane, Queensland, Australien, 4101
        • Mater Cancer Care Centre
      • Tugun, Queensland, Australien, 4224
        • John Flynn Private Hospital
    • South Australia
      • Elizabeth Vale, South Australia, Australien, 5112
        • Lyell McEwin Hospital
    • Victoria
      • Ballarat, Victoria, Australien, 3350
        • Ballarat Health Services
      • Clayton, Victoria, Australien, 3168
        • Monash Health
      • St Albans, Victoria, Australien, 3021
        • Western Health Sunshine Hospital
    • Western Australia
      • Murdoch, Western Australia, Australien, 6150
        • St John of God, Murdoch
  • Brasilien
      • Brasília, Brasilien, 70390140
        • Instituto Dor de Pesquisa E Ensino Distrito Federal
      • Cachoeiro de Itapemirim, Brasilien, 29308-020
        • Hospital Evangélico de Cachoeiro de Itapemirim
      • Florianópolis, Brasilien, 88034-000
        • Centro de Pesquisas Oncologicas Cepon
      • Fortaleza, Brasilien, 60430-235
        • Cancer Institute of Ceara
      • Santo André, Brasilien, 09060-650
        • Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
      • São José do Rio Preto, Brasilien, 15090-000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • Forenede Stater
    • California
      • Fullerton, California, Forenede Stater, 92835
        • Providence Medical Foundation St Jude Heritage Healthcare
      • Los Angeles, California, Forenede Stater, 90067
        • Valkyrie Clinical Trials
    • Florida
      • Ocala, Florida, Forenede Stater, 34474
        • Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
      • Orlando, Florida, Forenede Stater, 32804
        • Advent Health Cancer Institute
    • Indiana
      • Goshen, Indiana, Forenede Stater, 46526
        • Goshen Center for Cancer Care
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • Baptist Health Lexington
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • University Medical Center New Orleans West Jefferson Medical Center
    • Minnesota
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Metro Minnesota Community Oncology Research Consortium (MMCORC)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • West Penn Hospital
  • Frankrig
      • Bayonne, Frankrig, 64100
        • Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
      • Bordeaux, Frankrig, 33076
        • Centre de Lutte Contre Le Cancer Institut Bergonie
      • Lyon, Frankrig, 69317
        • Hopital de la croix rousse
      • Lyon, Frankrig, 69500
        • Hôpital Louis Pradel
      • Montpellier, Frankrig, 24298
        • Icm Val Daurelle Oncologie Medicale
      • Nancy, Frankrig, 54100
        • Polyclinique de Gentilly
      • Paris, Frankrig, 75014
        • Hôpital Cochin
      • PierreBenite, Frankrig, 69495
        • Chu Hopital Lyon Sud
      • Saint-Mandé, Frankrig, 94160
        • HIA Begin
      • Saint-Pierre, Frankrig, 97448
        • CHU de la réunion
      • SaintHerblain, Frankrig, 44805
        • Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
      • SaintHerblain, Frankrig, 44805
        • Chu Nantes Hopital Nord Laennec
      • Tours, Frankrig, 37000
        • Chu Tours Hopital Bretonneau Service Pneumologie
  • Georgien
      • Batumi, Georgien, 6000
        • High Technology Hospital MedCenter Ltd
      • Tbilisi, Georgien, 0186
        • Multiprofile Clinic Consilium Medulla LTD
      • Tbilisi, Georgien, 0159
        • Institute of Clinical Oncology Ltd
      • Tbilisi, Georgien, 0112
        • Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
      • Tbilisi, Georgien, 0112
        • Israel Georgian Medical Research Clinic Helsicore Ltd
      • Tbilisi, Georgien, 0119
        • Jsc German Hospital
      • Tbilisi, Georgien, 0159
        • Jsc Evex Hospitals Tbilisi
      • Tbilisi, Georgien, 0160
        • Tim Tbilisi Institute of Medicine Ltd
      • Tbilisi, Georgien, 0186
        • Caucasus Medical Centre Ltd
      • Tbilisi, Georgien, 0186
        • Oncology Research Center Ltd
  • Holland
      • Amersfoort, Holland, 3813 TZ
        • Meander Medisch Centrum
      • Arnhem, Holland, 6815 AD
        • Rijnstate
      • Harderwijk, Holland, 3844 DG
        • Ziekenhuis St Jansdal
      • Heerlen, Holland, 6419 PC
        • Stichting Zuyderland Medisch Centrum
      • Zwolle, Holland, 8025 AB
        • Isala Klinieken Zwolle
  • Italien
      • Bologna, Italien, 40138
        • Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
      • Messina, Italien, 98158
        • Azienda Ospedaliera Papardo
      • Orbassano, Italien, 10043
        • AOU San Luigi Gonzaga
  • Japan
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Nagoya University Hospital
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Hirosaki University Hospital
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • NHO Shikoku Cancer Center
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Kurume University Hospital
    • Gunma
      • Shibukawa, Gunma, Japan, 337-0280
        • National Hospital Organization Shibukawa Medical Center
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0017
        • Kobe University Hospital
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Medical Center General Hospital
      • Nishinomiyashi, Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Kanazawa University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Miyagi
      • Natorishi, Miyagi, Japan, 981-1293
        • Miyagi Cancer Center
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 700-8558
        • Okayama University Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Sakai, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki Chuo Chest Medical Center
      • Sayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Toyonaka, Osaka, Japan, 560-8552
        • Osaka Toneyama Medical Center
    • Tochigi
      • Shimonotsuke, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
      • Shimotsugagun, Tochigi, Japan, 321-0293
        • Dokkyo Medical University Hospital
      • Utsunomiya, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center
    • Tokyo
      • Bunkyoku, Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital
      • Kotoku, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of JFCR
  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230601
        • The Second Hospital of Anhui Medical University
      • Hefei, Anhui, Kina, 230000
        • Anhui Provincial Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, Kina, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, Kina, 100020
        • Beijing Chao Yang Hospital
      • Beijing, Beijing Municipality, Kina, 101149
        • Beijing Chest Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400030
        • Chongqing Cancer Hospital
      • Chongqing, Chongqing Municipality, Kina, 400042
        • Daping Hospital, Third Military Medical University
      • Chongqing, Chongqing Municipality, Kina, 400038
        • The First Affiliated Hospital of Army Military Medical University
      • Chongqing, Chongqing Municipality, Kina, 404000
        • Chongqing University Three Gorges Central Hospital
    • Fujian
      • Fuzhou, Fujian, Kina, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, Kina, 350014
        • Fujian Cancer Hospital
      • Xiamen, Fujian, Kina, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510030
        • Affiliated Cancer Hospital and institute of Guangzhou Medical University
      • Shantou, Guangdong, Kina, 515031
        • Cancer Hospital of Shantou University Medical College
      • Shenzhen, Guangdong, Kina, 518020
        • Shenzhen Peoples Hospital
    • Guangxi
      • Nanning, Guangxi, Kina, 530021
        • The Peoples Hospital of Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi, Kina, 530021
        • The Tumor Hospital Affiliated to Guangxi Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, Kina, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, Kina, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, Kina, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, Kina, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, Kina, 430022
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, Kina, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Changzhou, Jiangsu, Kina, 213003
        • Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
      • Nanjing, Jiangsu, Kina, 210029
        • Nanjing Chest Hospital
      • Nanjing, Jiangsu, Kina, 210009
        • Nanjing First Hospital
      • Suzhou, Jiangsu, Kina, 215000
        • The Second Affiliated Hospital of Soochow University
      • Suzhou, Jiangsu, Kina, 215006
        • The First Affiliated Hospital of Soochow University Branch Shizi
      • Xuzhou, Jiangsu, Kina, 221000
        • Xuzhou Central Hospital
    • Liaoning
      • Shenyang, Liaoning, Kina, 110042
        • Liaoning Cancer Hospital and Institute
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • The First Affiliated Hospital of Xian Jiaotong University
    • Shandong
      • Qingdao, Shandong, Kina, 266000
        • The Affiliated Hospital of Qingdao University Branch Laoshan
      • Weifang, Shandong, Kina, 261000
        • Weifang Peoples Hospital
      • Yantai, Shandong, Kina, 264000
        • Yantai Yuhuangding Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200433
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai Municipality, Kina, 200030
        • Shanghai Chest Hospital
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Affiliated Zhongshan Hospital of Fudan University
    • Shanxi
      • Taiyuan, Shanxi, Kina, 030032
        • Shanxi Bethune Hospital
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, Kina, 610041
        • Sichuan Cancer Hospital and Institute
      • Nanchong, Sichuan, Kina, 637000
        • Affiliated Hospital of North Sichuan Medical College
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, Kina, 300052
        • Tianjin Medical University General Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, Kina, 830000
        • Affiliated Cancer Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, Kina, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Ningbo, Zhejiang, Kina, 315010
        • The First Affiliated Hospital of Ningbo University
      • Taizhou, Zhejiang, Kina, 317000
        • Taizhou Hospital of Zhejiang
      • Yiwu, Zhejiang, Kina, 322000
        • The Fourth Affiliated Hospital Zhejiang University School of Medicine
  • Polen
      • Bialystok, Polen, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Lodz, Polen, 93-510
        • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
      • Lodz, Polen, 90-338
        • Centrum Terapii Wspoczesnej
      • Poznan, Polen, 60-569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii
      • Poznan, Polen, 60-693
        • Przychodnia Med Polonia Sp Z Oo
      • Zamość, Polen, 22-400
        • ETG Zamosc
  • Rusland
    • Arkhangelskaya oblast
      • Arkhangelsk, Arkhangelskaya oblast, Rusland, 163045
        • Arkhangelsk Regional Clinical Oncological Dispensary
    • Bashkortostan Republic
      • Ufa, Bashkortostan Republic, Rusland, 450054
        • State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic
    • Chelyabinsk Oblast
      • Magnitogorsk, Chelyabinsk Oblast, Rusland, 455001
        • State Budgetary Healthcare Institution Regional Oncology Dispensary Number
    • Moscow
      • Moscow, Moscow, Rusland, 121309
        • VitaMed LLC
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Rusland, 603081
        • State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
    • Omsk Oblast
      • Omsk, Omsk Oblast, Rusland, 644013
        • Bih of Omsk Region Clinical Oncology Dispensary
    • Samaraskaya Oblast'
      • Samara, Samaraskaya Oblast', Rusland, 443031
        • State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rusland, 197082
        • Llc Av Medical Group
  • Spanien
      • Alcorcón, Spanien, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Barcelona, Spanien, 08003
        • Hospital del Mar
      • Barcelona, Spanien, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spanien, 08035
        • Hospital Universitario Vall dHebron
      • Barcelona, Spanien, 8028
        • Hospital Universitari Quiron Dexeus
      • Elche, Spanien, 3203
        • Hospital General Universitario de Elche
      • Girona, Spanien, 17007
        • ICO Girona
      • Jaén, Spanien, 23007
        • Hospital Universitario de Jaén
      • Las Palmas, Spanien, 35016
        • Complejo Hospitalario Universitario Insular Gran Canaria
      • Lugo, Spanien, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spanien, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz
      • Madrid, Spanien, 28041
        • Hospital Universitario Doce de Octubre
      • Madrid, Spanien, 28040
        • Start Madrid Fundacion Jimenez Diaz
      • Majadahonda, Spanien, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda
      • Murcia, Spanien, 30008
        • Hospital General Universitario Morales Meseguer
      • Málaga, Spanien, 29010
        • Hospital Regional Universitario de Malaga
      • Málaga, Spanien, 29010
        • Hospital Universitario Virgen de la Victoria
      • Ourense, Spanien, 32005
        • Complexo Hospitalario Universitario de Ourense
      • Palma de Mallorca, Spanien, 07120
        • Hospital Universitari Son Espases
      • Seville, Spanien, 41013
        • Hospital Universitario Virgen del Rocio
      • Seville, Spanien, 41014
        • Hospital Universitario Nuestra Señora de Valme
      • Valencia, Spanien, 46026
        • Hospital Universitari i Politècnic La Fe
      • Valencia, Spanien, 46015
        • Hospital Arnau de Vilanova
  • Sydkorea
    • Chungcheongbukdo
      • Cheongju-si, Chungcheongbukdo, Sydkorea, 28644
        • Chungbuk National University Hospital
    • Daegu Gwang'yeogsi
      • Dalseogu, Daegu Gwang'yeogsi, Sydkorea, 42601
        • Keimyung University Dongsan Hospital
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Sydkorea, 14647
        • The Catholic University of Korea Bucheon St Marys Hospital
      • Gyeonggido, Gyeonggi-do, Sydkorea, 13496
        • CHA Bundang Medical Center, CHA University
      • Suwon, Gyeonggi-do, Sydkorea, 16247
        • The Catholic University of Korea, St Vincents Hospital
    • Gyeongsangbukdo
      • Daegu, Gyeongsangbukdo, Sydkorea, 41404
        • Kyungpook National University Chilgok Hospital
    • Seoul Teugbyeolsi
      • Eunpyeonggu, Seoul Teugbyeolsi, Sydkorea, 03312
        • The Catholic University of Korea, Eunpyeong St Marys Hospital
      • Seoul, Seoul Teugbyeolsi, Sydkorea, 03722
        • Severance Hospital Yonsei University Health System
  • Taiwan
      • Changhua, Taiwan, 50006
        • Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 231405
        • Taipei Tzu Chi Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital
      • Yunlin, Taiwan, 640
        • National Taiwan University Hospital Yunlin Branch
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
      • Hat Yai, Thailand, 90110
        • Songklanagarind Hospital (Prince of Songkhla University)
      • Lak Si, Thailand, 10210
        • Chulabhorn Research Institute
      • Muang, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
      • Muang, Thailand, 40002
        • Srinagarind Hospital (Khon Kaen University)
      • Ratchathewi, Thailand, 10400
        • Phramongkutklao Hospital
      • Ratchathewi, Thailand, 10400
        • Rajavithi Hospital
  • Tyrkiet (Türkiye)
      • Adana, Tyrkiet (Türkiye), 01130
        • Acibadem Adana Hospital
      • Adana, Tyrkiet (Türkiye), 1240
        • Baskent University Practice and Research Hospital Adana Medical Oncology Department
      • Ankara, Tyrkiet (Türkiye), 6520
        • Memorial Ankara Hospital
      • Ankara, Tyrkiet (Türkiye), 06200
        • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
      • Battalgazi, Tyrkiet (Türkiye), 44280
        • Inonu Universitesi Tip Fakultesi
      • Edirne, Tyrkiet (Türkiye), 22030
        • Tr Trakya University Health Research and Application Center (Hospital)
      • Istanbul, Tyrkiet (Türkiye), 34098
        • Iu C, Clinical Research Excellence Application and Research Center
      • Istanbul, Tyrkiet (Türkiye), 34722
        • Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
      • Izmir, Tyrkiet (Türkiye), 35100
        • Ege University Medical Faculty
      • Kocaeli, Tyrkiet (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi
      • Meram, Tyrkiet (Türkiye), 42090
        • Necmettin Erbakan University Selcuklu Faculty of Medicine
      • Mersin City Hospital, Tyrkiet (Türkiye), 33240
        • Mersin City Hospital
  • Tyskland
      • Aachen, Tyskland, 52074
        • Universitaetsklinikum Aachen
      • Bonn, Tyskland, 53127
        • Universitätsklinikum Bonn
      • Cologne, Tyskland, 51109
        • Kliniken der Stadt Koeln gGmbH
      • Giessen, Tyskland, 35392
        • Uniklinikum Giessen Marburg
      • Grohansdorf, Tyskland, 22927
        • LungenClinic Großhansdorf GmbH
      • Hamburg, Tyskland, 20251
        • Ambulantes Krebszentrum Hamburg
      • Munich, Tyskland, 81925
        • Munchen Klinik Bogenhausen
      • Rotenburg (Wümme), Tyskland, 27356
        • Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
  • Ukraine
      • Kryvyi Rih, Ukraine, 50000
        • Medical Center of Limited Liability Company Mriya Med Service
      • Uzhhorod, Ukraine, 88000
        • Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
      • Uzhhorod, Ukraine, 88011
        • Zakarpatska Regional Clinical Oncological Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Nøgleinklusionskriterier:

  1. Histologisk eller cytologisk dokumenteret lokalt fremskreden eller tilbagevendende ikke-småcellet lungecancer (NSCLC), der ikke er berettiget til helbredende kirurgi og/eller definitiv strålebehandling med eller uden kemoradioterapi, eller metastatisk-ikke-skælcellet eller pladecellet NSCLC.
  2. Ingen forudgående systemisk behandling for metastatisk NSCLC.
  3. Aftale om at udlevere arkivvæv eller frisk biopsi (hvis arkivvæv ikke er tilgængeligt).
  4. Tumorer med PD-L1 udtrykt i ≥ 50 % tumorceller.
  5. Mindst 1 målbar læsion som defineret i RECIST v1.1.
  6. ECOG Performance Status ≤ 1.

Nøgleekskluderingskriterier:

  1. Kendte mutationer i genet for epidermal vækstfaktorreceptor (EGFR), anaplastisk lymfomkinase (ALK) fusionsonkogen, BRAF V600E eller ROS1.
  2. Forudgående behandling med et anti-programmeret celledødsprotein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-celle immunoglobulin og ITIM (anti-TIGIT) domæne eller ethvert andet antistof eller lægemiddel, der specifikt er målrettet mod T-celle-costimulering eller checkpoint-veje.
  3. Aktiv leptomeningeal sygdom eller ukontrolleret, ubehandlet hjernemetastase.
  4. Aktive autoimmune sygdomme eller historie med autoimmune sygdomme, der kan komme tilbage.

Bemærk: Andre protokoldefinerede inklusions-/eksklusionskriterier kan være gældende

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Tislelizumab
Tislelizumab er et monoklonalt antistof formuleret til intravenøs injektion.
Andre navne:
  • BGB-A317
Medicin: Ociperlimab
Ociperlimab er et monoklonalt antistof formuleret til intravenøs injektion.
Andre navne:
  • BGB-A1217
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.
Medicin: Pembrolizumab
Pembrolizumab er et monoklonalt antistof formuleret til intravenøs injektion.
Andre navne:
  • KEYTRUDA
Medicin: Placebo
Placebo-infusioner vil bestå af en steril, normal saltvandsopløsning.
Placebo komparator: 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.
Medicin: Tislelizumab
Tislelizumab er et monoklonalt antistof formuleret til intravenøs injektion.
Andre navne:
  • BGB-A317
Medicin: Placebo
Placebo-infusioner vil bestå af en steril, normal saltvandsopløsning.
Eksperimentel: 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.
Medicin: Tislelizumab
Tislelizumab er et monoklonalt antistof formuleret til intravenøs injektion.
Andre navne:
  • BGB-A317
Medicin: Ociperlimab
Ociperlimab er et monoklonalt antistof formuleret til intravenøs injektion.
Andre navne:
  • BGB-A1217

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS) in Arms A and B
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 38.9 months
Up to 38.9 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BeiGene

Efterforskere

  • Ledende efterforsker: Mark Socinski, Advent Health Orlando
  • Ledende efterforsker: Shun Lu, Shanghai Chest Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. maj 2021

Primær færdiggørelse (Faktiske)

30. maj 2025

Studieafslutning (Faktiske)

18. marts 2026

Datoer for studieregistrering

Først indsendt

5. februar 2021

Først indsendt, der opfyldte QC-kriterier

5. februar 2021

Først opslået (Faktiske)

10. februar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AdvanTIG-302
  • BGB-A317-A1217-302 (Anden identifikator: BeiGene)
  • CTR20211476/CTR20211464 (Anden identifikator: ChinaDrugTrials)
  • 2020-004985-21 (EudraCT nummer)
  • 2023-507317-10-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

See plan description

IPD-delingsadgangskriterier

See plan description

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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