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Eine Studie zu Ociperlimab mit Tislelizumab im Vergleich zu Pembrolizumab bei Teilnehmern mit unbehandeltem Lungenkrebs

20. April 2026 aktualisiert von: BeiGene

Eine randomisierte, doppelblinde Phase-3-Studie zu Ociperlimab, einem Anti-TIGIT-Antikörper, in Kombination mit Tislelizumab im Vergleich zu Pembrolizumab bei Patienten mit zuvor unbehandelten, PD-L1-selektierten und lokal fortgeschrittenen, nicht resezierbaren oder metastasierten nicht-kleinzelligen Patienten Lungenkrebs

Der Zweck der Studie ist der Vergleich des progressionsfreien Überlebens (PFS) zwischen Arm A (Ociperlimab in Kombination mit Tislelizumab) und Arm B (Pembrolizumab in Kombination mit Placebo), wie es von Prüfärzten gemäß Response Evaluation Criteria in Solid Tumors Version 1.1 ( RECIST v1.1) und zum Vergleich des Gesamtüberlebens (OS) zwischen Arm A und Arm B.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

669

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, 1409
        • Centro Medical Austral
      • San Miguel de Tucumán, Argentinien, 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 Evangelico 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
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
  • China
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
      • Hefei, Anhui, China, 230000
        • Anhui Provincial Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, Beijing Municipality, China, 100020
        • Beijing Chao Yang Hospital
      • Beijing, Beijing Municipality, China, 101149
        • Beijing Chest Hospital, Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing Cancer Hospital
      • Chongqing, Chongqing Municipality, China, 400042
        • Daping Hospital, Third Military Medical University
      • Chongqing, Chongqing Municipality, China, 400038
        • The First Affiliated Hospital of Army Military Medical University
      • Chongqing, Chongqing Municipality, China, 404000
        • Chongqing University Three Gorges Central Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China, 350014
        • Fujian Cancer Hospital
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China, 510030
        • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
      • Shantou, Guangdong, China, 515031
        • Cancer Hospital of Shantou University Medical College
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen Peoples Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The Peoples Hospital of Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi, China, 530021
        • The Tumor Hospital Affiliated to Guangxi Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China, 430022
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China, 410013
        • Hunan Cancer Hospital
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
      • Nanjing, Jiangsu, China, 210029
        • Nanjing Chest Hospital
      • Nanjing, Jiangsu, China, 210009
        • Nanjing First Hospital
      • Suzhou, Jiangsu, China, 215000
        • The Second Affiliated Hospital of Soochow University
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University Branch Shizi
      • Xuzhou, Jiangsu, China, 221000
        • Xuzhou Central Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital and Institute
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xian Jiaotong University
    • Shandong
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University Branch Laoshan
      • Weifang, Shandong, China, 261000
        • Weifang Peoples Hospital
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai Municipality, China, 200030
        • Shanghai Chest Hospital
      • Shanghai, Shanghai Municipality, China, 200032
        • Affiliated Zhongshan Hospital of Fudan University
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Bethune Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, China, 610041
        • Sichuan Cancer Hospital and Institute
      • Nanchong, Sichuan, China, 637000
        • Affiliated Hospital of North Sichuan Medical College
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Affiliated Cancer Hospital of Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliated Hospital of Ningbo University
      • Taizhou, Zhejiang, China, 317000
        • Taizhou Hospital of Zhejiang
      • Yiwu, Zhejiang, China, 322000
        • The Fourth Affiliated Hospital Zhejiang University School of Medicine
  • Deutschland
      • Aachen, Deutschland, 52074
        • Universitaetsklinikum Aachen
      • Bonn, Deutschland, 53127
        • Universitätsklinikum Bonn
      • Cologne, Deutschland, 51109
        • Kliniken der Stadt Koeln gGmbH
      • Giessen, Deutschland, 35392
        • Uniklinikum Giessen Marburg
      • Grohansdorf, Deutschland, 22927
        • LungenClinic Grosshansdorf GmbH
      • Hamburg, Deutschland, 20251
        • Ambulantes Krebszentrum Hamburg
      • Munich, Deutschland, 81925
        • Munchen Klinik Bogenhausen
      • Rotenburg (Wümme), Deutschland, 27356
        • Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
  • Frankreich
      • Bayonne, Frankreich, 64100
        • Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
      • Bordeaux, Frankreich, 33076
        • Centre de Lutte Contre Le Cancer Institut Bergonie
      • Lyon, Frankreich, 69317
        • Hopital de la croix rousse
      • Lyon, Frankreich, 69500
        • Hôpital Louis Pradel
      • Montpellier, Frankreich, 24298
        • Icm Val Daurelle Oncologie Medicale
      • Nancy, Frankreich, 54100
        • Polyclinique de Gentilly
      • Paris, Frankreich, 75014
        • Hôpital Cochin
      • PierreBenite, Frankreich, 69495
        • Chu Hopital Lyon Sud
      • Saint-Mandé, Frankreich, 94160
        • HIA Begin
      • Saint-Pierre, Frankreich, 97448
        • CHU de la Réunion
      • SaintHerblain, Frankreich, 44805
        • Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
      • SaintHerblain, Frankreich, 44805
        • CHU Nantes Hopital Nord Laennec
      • Tours, Frankreich, 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
  • 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
  • Niederlande
      • Amersfoort, Niederlande, 3813 TZ
        • Meander Medisch Centrum
      • Arnhem, Niederlande, 6815 AD
        • Rijnstate
      • Harderwijk, Niederlande, 3844 DG
        • Ziekenhuis St Jansdal
      • Heerlen, Niederlande, 6419 PC
        • Stichting Zuyderland Medisch Centrum
      • Zwolle, Niederlande, 8025 AB
        • Isala Klinieken Zwolle
  • 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
  • Russland
    • Arkhangelskaya oblast
      • Arkhangelsk, Arkhangelskaya oblast, Russland, 163045
        • Arkhangelsk Regional Clinical Oncological Dispensary
    • Bashkortostan Republic
      • Ufa, Bashkortostan Republic, Russland, 450054
        • State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic
    • Chelyabinsk Oblast
      • Magnitogorsk, Chelyabinsk Oblast, Russland, 455001
        • State Budgetary Healthcare Institution Regional Oncology Dispensary Number
    • Moscow
      • Moscow, Moscow, Russland, 121309
        • VitaMed LLC
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russland, 603081
        • State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
    • Omsk Oblast
      • Omsk, Omsk Oblast, Russland, 644013
        • Bih of Omsk Region Clinical Oncology Dispensary
    • Samaraskaya Oblast'
      • Samara, Samaraskaya Oblast', Russland, 443031
        • State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russland, 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 Jaen
      • Las Palmas, Spanien, 35016
        • Complejo Hospitalario Universitario Insular Gran Canaria
      • Lugo, Spanien, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spanien, 28040
        • Hospital Clinico 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 Málaga
      • 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
  • Südkorea
    • Chungcheongbukdo
      • Cheongju-si, Chungcheongbukdo, Südkorea, 28644
        • Chungbuk National University Hospital
    • Daegu Gwang'yeogsi
      • Dalseogu, Daegu Gwang'yeogsi, Südkorea, 42601
        • Keimyung University Dongsan Hospital
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Südkorea, 14647
        • The Catholic University of Korea Bucheon St Marys Hospital
      • Gyeonggido, Gyeonggi-do, Südkorea, 13496
        • CHA Bundang Medical Center, CHA University
      • Suwon, Gyeonggi-do, Südkorea, 16247
        • The Catholic University of Korea, St Vincents Hospital
    • Gyeongsangbukdo
      • Daegu, Gyeongsangbukdo, Südkorea, 41404
        • Kyungpook National University Chilgok Hospital
    • Seoul Teugbyeolsi
      • Eunpyeonggu, Seoul Teugbyeolsi, Südkorea, 03312
        • The Catholic University of Korea, Eunpyeong St Marys Hospital
      • Seoul, Seoul Teugbyeolsi, Südkorea, 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
  • Türkei (türkiye)
      • Adana, Türkei (türkiye), 01130
        • Acibadem Adana Hospital
      • Adana, Türkei (türkiye), 1240
        • Baskent University Practice and Research Hospital Adana Medical Oncology Department
      • Ankara, Türkei (türkiye), 6520
        • Memorial Ankara Hospital
      • Ankara, Türkei (türkiye), 06200
        • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
      • Battalgazi, Türkei (türkiye), 44280
        • Inonu Universitesi Tip Fakultesi
      • Edirne, Türkei (türkiye), 22030
        • Tr Trakya University Health Research and Application Center (Hospital)
      • Istanbul, Türkei (türkiye), 34098
        • Iu C, Clinical Research Excellence Application and Research Center
      • Istanbul, Türkei (türkiye), 34722
        • Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
      • Izmir, Türkei (türkiye), 35100
        • Ege University Medical Faculty
      • Kocaeli, Türkei (türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi
      • Meram, Türkei (türkiye), 42090
        • Necmettin Erbakan University Selcuklu Faculty of Medicine
      • Mersin City Hospital, Türkei (türkiye), 33240
        • Mersin City Hospital
  • 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
  • Vereinigte Staaten
    • California
      • Fullerton, California, Vereinigte Staaten, 92835
        • Providence Medical Foundation St Jude Heritage Healthcare
      • Los Angeles, California, Vereinigte Staaten, 90067
        • Valkyrie Clinical Trials
    • Florida
      • Ocala, Florida, Vereinigte Staaten, 34474
        • Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
      • Orlando, Florida, Vereinigte Staaten, 32804
        • Advent Health Cancer Institute
    • Indiana
      • Goshen, Indiana, Vereinigte Staaten, 46526
        • Goshen Center for Cancer Care
    • Kentucky
      • Lexington, Kentucky, Vereinigte Staaten, 40503
        • Baptist Health Lexington
    • Louisiana
      • New Orleans, Louisiana, Vereinigte Staaten, 70112
        • University Medical Center New Orleans West Jefferson Medical Center
    • Minnesota
      • Saint Paul, Minnesota, Vereinigte Staaten, 55101
        • Metro Minnesota Community Oncology Research Consortium (MMCORC)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
        • West Penn Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Wichtige Einschlusskriterien:

  1. Histologisch oder zytologisch dokumentierter lokal fortgeschrittener oder rezidivierender nicht-kleinzelliger Lungenkrebs (NSCLC), der nicht für eine kurative Operation und/oder endgültige Strahlentherapie mit oder ohne Radiochemotherapie geeignet ist, oder metastasierendes NSCLC ohne Plattenepithelkarzinom oder Plattenepithelkarzinom.
  2. Keine vorherige systemische Behandlung des metastasierten NSCLC.
  3. Zustimmung zur Bereitstellung von Archivgewebe oder frischer Biopsie (falls kein Archivgewebe verfügbar ist).
  4. Tumore mit PD-L1-Expression in ≥ 50 % der Tumorzellen.
  5. Mindestens 1 messbare Läsion gemäß RECIST v1.1.
  6. ECOG-Leistungsstatus ≤ 1.

Wichtige Ausschlusskriterien:

  1. Bekannte Mutationen im epidermalen Wachstumsfaktorrezeptor (EGFR)-Gen, anaplastisches Lymphomkinase (ALK)-Fusionsonkogen, BRAF V600E oder ROS1.
  2. Vorherige Therapie mit einem Anti-Programmed Cell Death Protein (Anti-PD)-1, Anti-PD-Ligand (L)-1, Anti-PD-Ligand-2, Anti-T-Zell-Immunglobulin und ITIM (Anti-TIGIT) -Domäne oder andere Antikörper oder Medikamente, die spezifisch auf T-Zell-Costimulation oder Checkpoint-Signalwege abzielen.
  3. Aktive leptomeningeale Erkrankung oder unkontrollierte, unbehandelte Hirnmetastasen.
  4. Aktive Autoimmunerkrankungen oder Vorgeschichte von Autoimmunerkrankungen, die rezidivieren können.

Hinweis: Es können andere im Protokoll definierte Einschluss-/Ausschlusskriterien gelten

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Tislelizumab
Tislelizumab ist ein monoklonaler Antikörper, der zur intravenösen Injektion formuliert ist.
Andere Namen:
  • BGB-A317
Arzneimittel: Ociperlimab
Ociperlimab ist ein monoklonaler Antikörper, der zur intravenösen Injektion formuliert ist.
Andere Namen:
  • BGB-A1217
Aktiver 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.
Arzneimittel: Pembrolizumab
Pembrolizumab ist ein monoklonaler Antikörper, der zur intravenösen Injektion formuliert ist.
Andere Namen:
  • KEYTRUDA
Arzneimittel: Placebo
Placebo-Infusionen bestehen aus einer sterilen, normalen Kochsalzlösung.
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.
Arzneimittel: Tislelizumab
Tislelizumab ist ein monoklonaler Antikörper, der zur intravenösen Injektion formuliert ist.
Andere Namen:
  • BGB-A317
Arzneimittel: Placebo
Placebo-Infusionen bestehen aus einer sterilen, normalen Kochsalzlösung.
Experimental: 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.
Arzneimittel: Tislelizumab
Tislelizumab ist ein monoklonaler Antikörper, der zur intravenösen Injektion formuliert ist.
Andere Namen:
  • BGB-A317
Arzneimittel: Ociperlimab
Ociperlimab ist ein monoklonaler Antikörper, der zur intravenösen Injektion formuliert ist.
Andere Namen:
  • BGB-A1217

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS) in Arms A and B
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Up to 38.9 months
Up to 38.9 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

BeiGene

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Mai 2021

Primärer Abschluss (Tatsächlich)

30. Mai 2025

Studienabschluss (Tatsächlich)

18. März 2026

Studienanmeldedaten

Zuerst eingereicht

5. Februar 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Februar 2021

Zuerst gepostet (Tatsächlich)

10. Februar 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

See plan description

IPD-Sharing-Zugriffskriterien

See plan description

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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