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Uno studio su ociperlimab con tislelizumab rispetto a pembrolizumab nei partecipanti con carcinoma polmonare non trattato

20 aprile 2026 aggiornato da: BeiGene

Uno studio di fase 3, randomizzato, in doppio cieco su ociperlimab, un anticorpo anti-TIGIT, in combinazione con tislelizumab rispetto a pembrolizumab in pazienti con cellule non a piccole cellule precedentemente non trattate, selezionate per PD-L1 e localmente avanzate, non resecabili o metastatiche Cancro ai polmoni

Lo scopo dello studio è confrontare la sopravvivenza libera da progressione (PFS) tra il braccio A (ociperlimab in combinazione con tislelizumab) e il braccio B (pembrolizumab in combinazione con placebo) valutata dai ricercatori secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 ( RECIST v1.1) e confrontare la sopravvivenza globale (OS) tra il braccio A e il braccio B.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

669

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criteri chiave di inclusione:

  1. Carcinoma polmonare non a piccole cellule (NSCLC) localmente avanzato o ricorrente, documentato istologicamente o citologicamente, non eleggibile per chirurgia curativa e/o radioterapia definitiva con o senza chemioradioterapia, o NSCLC metastatico-non squamoso o squamoso.
  2. Nessun precedente trattamento sistemico per NSCLC metastatico.
  3. Accordo per fornire tessuto d'archivio o biopsia fresca (se il tessuto d'archivio non è disponibile).
  4. Tumori con PD-L1 espresso in ≥ 50% di cellule tumorali.
  5. Almeno 1 lesione misurabile come definita da RECIST v1.1.
  6. Stato delle prestazioni ECOG ≤ 1.

Criteri chiave di esclusione:

  1. Mutazioni note nel gene del recettore del fattore di crescita epidermico (EGFR), oncogene di fusione della chinasi del linfoma anaplastico (ALK), BRAF V600E o ROS1.
  2. Precedente terapia con una proteina anti-morte cellulare programmata (anti-PD)-1, anti-PD-ligando (L)-1, anti-PD-ligando-2, immunoglobulina anti-cellula T e ITIM (anti-TIGIT) dominio, o qualsiasi altro anticorpo o farmaco mirato specificamente alla costimolazione delle cellule T o ai percorsi del checkpoint.
  3. Malattia leptomeningea attiva o metastasi cerebrali non controllate e non trattate.
  4. Malattie autoimmuni attive o storia di malattie autoimmuni che possono recidivare.

Nota: potrebbero essere applicati altri criteri di inclusione/esclusione definiti dal protocollo

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Tislelizumab
Tislelizumab è un anticorpo monoclonale formulato per l'iniezione endovenosa.
Altri nomi:
  • BGB-A317
Droga: Ociperlimab
Ociperlimab è un anticorpo monoclonale formulato per l'iniezione endovenosa.
Altri nomi:
  • BGB-A1217
Comparatore attivo: 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.
Droga: Pembrolizumab
Pembrolizumab è un anticorpo monoclonale formulato per l'iniezione endovenosa.
Altri nomi:
  • KEYTRUDA
Droga: Placebo
Le infusioni di placebo consisteranno in una normale soluzione salina sterile.
Comparatore placebo: Arm C: Tislelizumab plus Placebo
Participants received tislelizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.
Droga: Tislelizumab
Tislelizumab è un anticorpo monoclonale formulato per l'iniezione endovenosa.
Altri nomi:
  • BGB-A317
Droga: Placebo
Le infusioni di placebo consisteranno in una normale soluzione salina sterile.
Sperimentale: 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.
Droga: Tislelizumab
Tislelizumab è un anticorpo monoclonale formulato per l'iniezione endovenosa.
Altri nomi:
  • BGB-A317
Droga: Ociperlimab
Ociperlimab è un anticorpo monoclonale formulato per l'iniezione endovenosa.
Altri nomi:
  • BGB-A1217

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS) in Arms A and B
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Up to 38.9 months
Up to 38.9 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

BeiGene

Investigatori

  • Investigatore principale: Mark Socinski, Advent Health Orlando
  • Investigatore principale: Shun Lu, Shanghai Chest Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 maggio 2021

Completamento primario (Effettivo)

30 maggio 2025

Completamento dello studio (Effettivo)

18 marzo 2026

Date di iscrizione allo studio

Primo inviato

5 febbraio 2021

Primo inviato che soddisfa i criteri di controllo qualità

5 febbraio 2021

Primo Inserito (Effettivo)

10 febbraio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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.

Periodo di condivisione IPD

See plan description

Criteri di accesso alla condivisione IPD

See plan description

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

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Sponsor / Collaboratori

Sedi

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