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Studie ociperlimabu s tislelizumabem ve srovnání s pembrolizumabem u účastníků s neléčenou rakovinou plic

20. dubna 2026 aktualizováno: BeiGene

Randomizovaná, dvojitě zaslepená studie fáze 3 ociperlimabu, protilátky proti TIGIT, v kombinaci s tislelizumabem ve srovnání s pembrolizumabem u pacientů s dříve neléčenými, PD-L1 vybranými a lokálně pokročilými, neresekovatelnými nebo metastatickými nemalobuněčnými buňkami Rakovina plic

Účelem studie je porovnat přežití bez progrese (PFS) mezi ramenem A (ociperlimab v kombinaci s tislelizumabem) a ramenem B (pembrolizumab v kombinaci s placebem), jak bylo hodnoceno zkoušejícími podle kritérií hodnocení odpovědi u solidních nádorů verze 1.1 ( RECIST v1.1) a porovnat celkové přežití (OS) mezi ramenem A a ramenem B.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

669

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Popis

Klíčová kritéria pro zařazení:

  1. Histologicky nebo cytologicky dokumentovaný lokálně pokročilý nebo recidivující nemalobuněčný karcinom plic (NSCLC), který není způsobilý pro kurativní operaci a/nebo definitivní radioterapii s chemoradioterapií nebo bez ní, nebo metastatický-neskvamózní nebo skvamózní NSCLC.
  2. Žádná předchozí systémová léčba metastatického NSCLC.
  3. Souhlas s poskytnutím archivní tkáně nebo čerstvé biopsie (pokud archivní tkáň není k dispozici).
  4. Nádory s PD-L1 exprimované v ≥ 50 % nádorových buněk.
  5. Alespoň 1 měřitelná léze podle definice podle RECIST v1.1.
  6. Stav výkonu ECOG ≤ 1.

Klíčová kritéria vyloučení:

  1. Známé mutace v genu receptoru epidermálního růstového faktoru (EGFR), fúzního onkogenu kinázy anaplastického lymfomu (ALK), BRAF V600E nebo ROS1.
  2. Předchozí léčba proteinem proti programované buněčné smrti (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-buněčný imunoglobulin a ITIM (anti-TIGIT) doména nebo jakákoli jiná protilátka nebo léčivo specificky zacílené na kostimulaci T-buněk nebo dráhy kontrolních bodů.
  3. Aktivní leptomeningeální onemocnění nebo nekontrolované, neléčené mozkové metastázy.
  4. Aktivní autoimunitní onemocnění nebo anamnéza autoimunitních onemocnění, která mohou recidivovat.

Poznámka: Mohou platit jiná kritéria pro zařazení/vyloučení definovaná protokolem

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: Tislelizumab
Tislelizumab je monoklonální protilátka formulovaná pro intravenózní injekci.
Ostatní jména:
  • BGB-A317
Lék: Ociperlimab
Ociperlimab je monoklonální protilátka formulovaná pro intravenózní injekci.
Ostatní jména:
  • BGB-A1217
Aktivní komparátor: 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.
Lék: Pembrolizumab
Pembrolizumab je monoklonální protilátka formulovaná pro intravenózní injekci.
Ostatní jména:
  • KEYTRUDA
Lék: Placebo
Infuze placeba se budou skládat ze sterilního, normálního fyziologického roztoku.
Komparátor placeba: 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.
Lék: Tislelizumab
Tislelizumab je monoklonální protilátka formulovaná pro intravenózní injekci.
Ostatní jména:
  • BGB-A317
Lék: Placebo
Infuze placeba se budou skládat ze sterilního, normálního fyziologického roztoku.
Experimentální: 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.
Lék: Tislelizumab
Tislelizumab je monoklonální protilátka formulovaná pro intravenózní injekci.
Ostatní jména:
  • BGB-A317
Lék: Ociperlimab
Ociperlimab je monoklonální protilátka formulovaná pro intravenózní injekci.
Ostatní jména:
  • BGB-A1217

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival (OS) in Arms A and B
Časové okno: 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)
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Up to 38.9 months
Up to 38.9 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

BeiGene

Vyšetřovatelé

  • Vrchní vyšetřovatel: Mark Socinski, Advent Health Orlando
  • Vrchní vyšetřovatel: Shun Lu, Shanghai Chest Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

24. května 2021

Primární dokončení (Aktuální)

30. května 2025

Dokončení studie (Aktuální)

18. března 2026

Termíny zápisu do studia

První předloženo

5. února 2021

První předloženo, které splnilo kritéria kontroly kvality

5. února 2021

První zveřejněno (Aktuální)

10. února 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

20. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Časový rámec sdílení IPD

See plan description

Kritéria přístupu pro sdílení IPD

See plan description

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Tislelizumab

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