未治療の肺癌の参加者におけるペンブロリズマブと比較したティスレリズマブとオシペリマブの研究
2026年4月20日 更新者：BeiGene
未治療、PD-L1選択型、および局所進行、切除不能、または転移性非小細胞の患者におけるペムブロリズマブと比較した、抗TIGIT抗体であるオシペルリマブとチスレリズマブの併用の第3相ランダム化二重盲検試験肺癌
この研究の目的は、固形腫瘍の反応評価基準バージョン 1.1 ( RECIST v1.1) を参照し、Arm A と Arm B の全生存期間 (OS) を比較します。
調査の概要
研究の種類
介入
入学 (実際)
669
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Fullerton、California、アメリカ、92835
- Providence Medical Foundation St Jude Heritage Healthcare
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Los Angeles、California、アメリカ、90067
- Valkyrie Clinical Trials
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Florida
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Ocala、Florida、アメリカ、34474
- Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
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Orlando、Florida、アメリカ、32804
- Advent Health Cancer Institute
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Indiana
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Goshen、Indiana、アメリカ、46526
- Goshen Center for Cancer Care
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-
Kentucky
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Lexington、Kentucky、アメリカ、40503
- Baptist Health Lexington
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- University Medical Center New Orleans West Jefferson Medical Center
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-
Minnesota
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Saint Paul、Minnesota、アメリカ、55101
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15224
- West Penn Hospital
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-
-
-
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Buenos Aires、アルゼンチン、1409
- Centro Medical Austral
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San Miguel de Tucumán、アルゼンチン、4000
- Centro Para La Atencion Del Paciente Oncologico (Caipo)
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-
-
-
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Bologna、イタリア、40138
- Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
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Messina、イタリア、98158
- Azienda Ospedaliera Papardo
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Orbassano、イタリア、10043
- AOU San Luigi Gonzaga
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-
-
-
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Kryvyi Rih、ウクライナ、50000
- Medical Center of Limited Liability Company Mriya Med Service
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Uzhhorod、ウクライナ、88000
- Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
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Uzhhorod、ウクライナ、88011
- Zakarpatska Regional Clinical Oncological Center
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-
-
-
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Amersfoort、オランダ、3813 TZ
- Meander Medisch Centrum
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Arnhem、オランダ、6815 AD
- Rijnstate
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Harderwijk、オランダ、3844 DG
- Ziekenhuis St Jansdal
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Heerlen、オランダ、6419 PC
- Stichting Zuyderland Medisch Centrum
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Zwolle、オランダ、8025 AB
- Isala Klinieken Zwolle
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-
-
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New South Wales
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Concord、New South Wales、オーストラリア、2139
- Concord Repatriation General Hospital
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St Leonards、New South Wales、オーストラリア、2065
- Northern Cancer Institute
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Waratah、New South Wales、オーストラリア、2298
- Calvary Mater Newcastle
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Queensland
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Benowa、Queensland、オーストラリア、4217
- Pindara Private Hospital
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Chermside、Queensland、オーストラリア、4032
- The Prince Charles Hospital
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South Brisbane、Queensland、オーストラリア、4101
- Mater Cancer Care Centre
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Tugun、Queensland、オーストラリア、4224
- John Flynn Private Hospital
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South Australia
-
Elizabeth Vale、South Australia、オーストラリア、5112
- Lyell McEwin Hospital
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Victoria
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Ballarat、Victoria、オーストラリア、3350
- Ballarat Health Services
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Clayton、Victoria、オーストラリア、3168
- Monash Health
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St Albans、Victoria、オーストラリア、3021
- Western Health Sunshine Hospital
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Western Australia
-
Murdoch、Western Australia、オーストラリア、6150
- St John of God, Murdoch
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-
-
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Batumi、グルジア、6000
- High Technology Hospital MedCenter Ltd
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Tbilisi、グルジア、0186
- Multiprofile Clinic Consilium Medulla Ltd
-
Tbilisi、グルジア、0159
- Institute of Clinical Oncology Ltd
-
Tbilisi、グルジア、0112
- Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
-
Tbilisi、グルジア、0112
- Israel Georgian Medical Research Clinic Helsicore Ltd
-
Tbilisi、グルジア、0119
- Jsc German Hospital
-
Tbilisi、グルジア、0159
- Jsc Evex Hospitals Tbilisi
-
Tbilisi、グルジア、0160
- Tim Tbilisi Institute of Medicine Ltd
-
Tbilisi、グルジア、0186
- Caucasus Medical Centre Ltd
-
Tbilisi、グルジア、0186
- Oncology Research Center Ltd
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-
-
-
-
Alcorcón、スペイン、28922
- Hospital Universitario Fundacion Alcorcon
-
Barcelona、スペイン、08003
- Hospital Del Mar
-
Barcelona、スペイン、08025
- Hospital de La Santa Creu i Sant Pau
-
Barcelona、スペイン、08035
- Hospital Universitario Vall Dhebron
-
Barcelona、スペイン、8028
- Hospital Universitari Quiron Dexeus
-
Elche、スペイン、3203
- Hospital General Universitario de Elche
-
Girona、スペイン、17007
- ICO Girona
-
Jaén、スペイン、23007
- Hospital Universitario de Jaén
-
Las Palmas、スペイン、35016
- Complejo Hospitalario Universitario Insular Gran Canaria
-
Lugo、スペイン、27003
- Hospital Universitario Lucus Augusti
-
Madrid、スペイン、28040
- Hospital Clinico San Carlos
-
Madrid、スペイン、28046
- Hospital Universitario La Paz
-
Madrid、スペイン、28041
- Hospital Universitario Doce de Octubre
-
Madrid、スペイン、28040
- Start Madrid Fundacion Jimenez Diaz
-
Majadahonda、スペイン、28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
Murcia、スペイン、30008
- Hospital General Universitario Morales Meseguer
-
Málaga、スペイン、29010
- Hospital Regional Universitario de Málaga
-
Málaga、スペイン、29010
- Hospital Universitario Virgen de la Victoria
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Ourense、スペイン、32005
- Complexo Hospitalario Universitario de Ourense
-
Palma de Mallorca、スペイン、07120
- Hospital Universitari Son Espases
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Seville、スペイン、41013
- Hospital Universitario Virgen del Rocío
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Seville、スペイン、41014
- Hospital Universitario Nuestra Señora de Valme
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Valencia、スペイン、46026
- Hospital Universitari i Politecnic La Fe
-
Valencia、スペイン、46015
- Hospital Arnau de Vilanova
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-
-
-
-
Bangkok、タイ、10700
- Siriraj Hospital
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Hat Yai、タイ、90110
- Songklanagarind Hospital (Prince of Songkhla University)
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Lak Si、タイ、10210
- Chulabhorn Research Institute
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Muang、タイ、50200
- Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
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Muang、タイ、40002
- Srinagarind Hospital (Khon Kaen University)
-
Ratchathewi、タイ、10400
- Phramongkutklao Hospital
-
Ratchathewi、タイ、10400
- Rajavithi Hospital
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-
-
-
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Adana、トルコ（Türkiye）、01130
- Acibadem Adana Hospital
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Adana、トルコ（Türkiye）、1240
- Baskent University Practice and Research Hospital Adana Medical Oncology Department
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Ankara、トルコ（Türkiye）、6520
- Memorial Ankara Hospital
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Ankara、トルコ（Türkiye）、06200
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Battalgazi、トルコ（Türkiye）、44280
- Inonu Universitesi Tip Fakultesi
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Edirne、トルコ（Türkiye）、22030
- Tr Trakya University Health Research and Application Center (Hospital)
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Istanbul、トルコ（Türkiye）、34098
- Iu C, Clinical Research Excellence Application and Research Center
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Istanbul、トルコ（Türkiye）、34722
- Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
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Izmir、トルコ（Türkiye）、35100
- Ege University Medical Faculty
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Kocaeli、トルコ（Türkiye）、41380
- Kocaeli Universitesi Tip Fakultesi
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Meram、トルコ（Türkiye）、42090
- Necmettin Erbakan University Selcuklu Faculty of Medicine
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Mersin City Hospital、トルコ（Türkiye）、33240
- Mersin City Hospital
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-
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Aachen、ドイツ、52074
- Universitaetsklinikum Aachen
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Bonn、ドイツ、53127
- Universitatsklinikum Bonn
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Cologne、ドイツ、51109
- Kliniken der Stadt Koeln gGmbH
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Giessen、ドイツ、35392
- Uniklinikum Giessen Marburg
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Grohansdorf、ドイツ、22927
- LungenClinic Grosshansdorf GmbH
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Hamburg、ドイツ、20251
- Ambulantes Krebszentrum Hamburg
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Munich、ドイツ、81925
- Munchen Klinik Bogenhausen
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Rotenburg (Wümme)、ドイツ、27356
- Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
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-
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Bayonne、フランス、64100
- Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
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Bordeaux、フランス、33076
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon、フランス、69317
- Hôpital de La Croix Rousse
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Lyon、フランス、69500
- Hopital Louis Pradel
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Montpellier、フランス、24298
- Icm Val Daurelle Oncologie Medicale
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Nancy、フランス、54100
- Polyclinique de Gentilly
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Paris、フランス、75014
- Hôpital Cochin
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PierreBenite、フランス、69495
- Chu Hopital Lyon Sud
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Saint-Mandé、フランス、94160
- HIA Begin
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Saint-Pierre、フランス、97448
- CHU de la Réunion
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SaintHerblain、フランス、44805
- Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
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SaintHerblain、フランス、44805
- CHU Nantes Hopital Nord Laennec
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Tours、フランス、37000
- Chu Tours Hopital Bretonneau Service Pneumologie
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-
-
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Brasília、ブラジル、70390140
- Instituto Dor de Pesquisa E Ensino Distrito Federal
-
Cachoeiro de Itapemirim、ブラジル、29308-020
- Hospital Evangélico de Cachoeiro de Itapemirim
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Florianópolis、ブラジル、88034-000
- Centro de Pesquisas Oncologicas Cepon
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Fortaleza、ブラジル、60430-235
- Cancer Institute of Ceara
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Santo André、ブラジル、09060-650
- Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
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São José do Rio Preto、ブラジル、15090-000
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
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-
-
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Bialystok、ポーランド、15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Lodz、ポーランド、93-510
- Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lodz、ポーランド、90-338
- Centrum Terapii Wspoczesnej
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Poznan、ポーランド、60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
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Poznan、ポーランド、60-693
- Przychodnia Med Polonia Sp Z Oo
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Zamość、ポーランド、22-400
- ETG Zamość
-
-
-
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Arkhangelskaya oblast
-
Arkhangelsk、Arkhangelskaya oblast、ロシア、163045
- Arkhangelsk Regional Clinical Oncological Dispensary
-
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Bashkortostan Republic
-
Ufa、Bashkortostan Republic、ロシア、450054
- State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic
-
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Chelyabinsk Oblast
-
Magnitogorsk、Chelyabinsk Oblast、ロシア、455001
- State Budgetary Healthcare Institution Regional Oncology Dispensary Number
-
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Moscow
-
Moscow、Moscow、ロシア、121309
- VitaMed LLC
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Nizhny Novgorod Oblast
-
Nizhny Novgorod、Nizhny Novgorod Oblast、ロシア、603081
- State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
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Omsk Oblast
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Omsk、Omsk Oblast、ロシア、644013
- Bih of Omsk Region Clinical Oncology Dispensary
-
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Samaraskaya Oblast'
-
Samara、Samaraskaya Oblast'、ロシア、443031
- State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
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Sankt-Peterburg
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Saint Petersburg、Sankt-Peterburg、ロシア、197082
- Llc Av Medical Group
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-
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Anhui
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Hefei、Anhui、中国、230601
- The Second Hospital of Anhui Medical University
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Hefei、Anhui、中国、230000
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100142
- Beijing Cancer Hospital
-
Beijing、Beijing Municipality、中国、100730
- Peking Union Medical College Hospital
-
Beijing、Beijing Municipality、中国、100020
- Beijing Chao Yang Hospital
-
Beijing、Beijing Municipality、中国、101149
- Beijing Chest Hospital, Capital Medical University
-
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400030
- Chongqing Cancer Hospital
-
Chongqing、Chongqing Municipality、中国、400042
- Daping Hospital, Third Military Medical University
-
Chongqing、Chongqing Municipality、中国、400038
- The First Affiliated Hospital of Army Military Medical University
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Chongqing、Chongqing Municipality、中国、404000
- Chongqing University Three Gorges Central Hospital
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Fujian
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Fuzhou、Fujian、中国、350001
- Fujian Medical University Union Hospital
-
Fuzhou、Fujian、中国、350014
- Fujian Cancer Hospital
-
Xiamen、Fujian、中国、361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou、Guangdong、中国、510030
- Affiliated Cancer Hospital and institute of Guangzhou Medical University
-
Shantou、Guangdong、中国、515031
- Cancer Hospital of Shantou University Medical College
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Shenzhen、Guangdong、中国、518020
- Shenzhen Peoples Hospital
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Guangxi
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Nanning、Guangxi、中国、530021
- The Peoples Hospital of Guangxi Zhuang Autonomous Region
-
Nanning、Guangxi、中国、530021
- The Tumor Hospital Affiliated to Guangxi Medical University
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国、150000
- Harbin Medical University Cancer Hospital
-
-
Henan
-
Zhengzhou、Henan、中国、450052
- The First Affiliated Hospital of Zhengzhou University
-
Zhengzhou、Henan、中国、450000
- Henan Cancer Hospital
-
-
Hubei
-
Wuhan、Hubei、中国、430079
- Hubei Cancer Hospital
-
Wuhan、Hubei、中国、430060
- Renmin Hospital of Wuhan University
-
Wuhan、Hubei、中国、430022
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
-
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Hunan
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Changsha、Hunan、中国、410013
- Hunan Cancer Hospital
-
Changsha、Hunan、中国、410011
- The Second Xiangya Hospital of Central South University
-
-
Jiangsu
-
Changzhou、Jiangsu、中国、213003
- Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
-
Nanjing、Jiangsu、中国、210029
- Nanjing Chest Hospital
-
Nanjing、Jiangsu、中国、210009
- Nanjing First Hospital
-
Suzhou、Jiangsu、中国、215000
- The Second Affiliated Hospital of Soochow University
-
Suzhou、Jiangsu、中国、215006
- The First Affiliated Hospital of Soochow University Branch Shizi
-
Xuzhou、Jiangsu、中国、221000
- Xuzhou Central Hospital
-
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Liaoning
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Shenyang、Liaoning、中国、110042
- Liaoning Cancer Hospital and Institute
-
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Shaanxi
-
Xi'an、Shaanxi、中国、710061
- The First Affiliated Hospital of Xian Jiaotong University
-
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Shandong
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Qingdao、Shandong、中国、266000
- The Affiliated Hospital of Qingdao University Branch Laoshan
-
Weifang、Shandong、中国、261000
- Weifang Peoples Hospital
-
Yantai、Shandong、中国、264000
- Yantai YuHuangDing Hospital
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200433
- Shanghai Pulmonary Hospital
-
Shanghai、Shanghai Municipality、中国、200030
- Shanghai Chest Hospital
-
Shanghai、Shanghai Municipality、中国、200032
- Affiliated Zhongshan Hospital of Fudan University
-
-
Shanxi
-
Taiyuan、Shanxi、中国、030032
- Shanxi Bethune Hospital
-
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Sichuan
-
Chengdu、Sichuan、中国、610041
- West China Hospital, Sichuan University
-
Chengdu、Sichuan、中国、610041
- Sichuan Cancer Hospital and Institute
-
Nanchong、Sichuan、中国、637000
- Affiliated Hospital of North Sichuan Medical College
-
-
Tianjin Municipality
-
Tianjin、Tianjin Municipality、中国、300060
- Tianjin Medical University Cancer Institute and Hospital
-
Tianjin、Tianjin Municipality、中国、300052
- Tianjin Medical University General Hospital
-
-
Xinjiang
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Ürümqi、Xinjiang、中国、830000
- Affiliated Cancer Hospital of Xinjiang Medical University
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310022
- Zhejiang Cancer Hospital
-
Hangzhou、Zhejiang、中国、310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Ningbo、Zhejiang、中国、315010
- The First Affiliated Hospital of Ningbo University
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Taizhou、Zhejiang、中国、317000
- Taizhou Hospital of Zhejiang
-
Yiwu、Zhejiang、中国、322000
- The Fourth Affiliated Hospital Zhejiang University School of Medicine
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-
-
-
-
Changhua、台湾、50006
- Changhua Christian Hospital
-
Kaohsiung City、台湾、83301
- Kaohsiung Chang Gung Memorial Hospital
-
Taichung、台湾、40201
- Chung Shan Medical University Hospital
-
Taipei、台湾、11217
- Taipei Veterans General Hospital
-
Taipei、台湾、231405
- Taipei Tzu Chi Hospital
-
Taoyuan、台湾、33305
- Linkou Chang Gung Memorial Hospital
-
Yunlin、台湾、640
- National Taiwan University Hospital Yunlin Branch
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-
-
-
-
Hiroshima、日本、734-8551
- Hiroshima University Hospital
-
Niigata、日本、951-8566
- Niigata Cancer Center Hospital
-
-
Aichi-ken
-
Nagoya、Aichi-ken、日本、466-8560
- Nagoya University Hospital
-
-
Aomori
-
Hirosaki、Aomori、日本、036-8563
- Hirosaki University Hospital
-
-
Ehime
-
Matsuyama、Ehime、日本、791-0280
- NHO Shikoku Cancer Center
-
-
Fukuoka
-
Kurume、Fukuoka、日本、830-0011
- Kurume University Hospital
-
-
Gunma
-
Shibukawa、Gunma、日本、337-0280
- National Hospital Organization Shibukawa Medical Center
-
-
Hyōgo
-
Kobe、Hyōgo、日本、650-0017
- Kobe University Hospital
-
Kobe、Hyōgo、日本、650-0047
- Kobe City Medical Center General Hospital
-
Nishinomiyashi、Hyōgo、日本、663-8501
- Hyogo Medical University Hospital
-
-
Ishikawa-ken
-
Kanazawa、Ishikawa-ken、日本、920-8641
- Kanazawa University Hospital
-
-
Kanagawa
-
Yokohama、Kanagawa、日本、241-8515
- Kanagawa Cancer Center
-
-
Miyagi
-
Natorishi、Miyagi、日本、981-1293
- Miyagi Cancer Center
-
-
Okayama-ken
-
Okayama、Okayama-ken、日本、700-8558
- Okayama University Hospital
-
-
Osaka
-
Hirakata、Osaka、日本、573-1191
- Kansai Medical University Hospital
-
Sakai、Osaka、日本、591-8555
- National Hospital Organization Kinki Chuo Chest Medical Center
-
Sayama、Osaka、日本、589-8511
- Kindai University Hospital
-
Toyonaka、Osaka、日本、560-8552
- Osaka Toneyama Medical Center
-
-
Tochigi
-
Shimonotsuke、Tochigi、日本、329-0498
- Jichi Medical University Hospital
-
Shimotsugagun、Tochigi、日本、321-0293
- Dokkyo Medical University Hospital
-
Utsunomiya、Tochigi、日本、320-0834
- Tochigi Cancer Center
-
-
Tokyo
-
Bunkyoku、Tokyo、日本、113-8603
- Nippon Medical School Hospital
-
Kotoku、Tokyo、日本、135-8550
- Cancer Institute Hospital of JFCR
-
-
-
-
Chungcheongbukdo
-
Cheongju-si、Chungcheongbukdo、韓国、28644
- Chungbuk National University Hospital
-
-
Daegu Gwang'yeogsi
-
Dalseogu、Daegu Gwang'yeogsi、韓国、42601
- Keimyung University Dongsan Hospital
-
-
Gyeonggi-do
-
Bucheon-si、Gyeonggi-do、韓国、14647
- The Catholic University of Korea Bucheon St Marys Hospital
-
Gyeonggido、Gyeonggi-do、韓国、13496
- CHA Bundang Medical Center, CHA University
-
Suwon、Gyeonggi-do、韓国、16247
- The Catholic University of Korea, St Vincents Hospital
-
-
Gyeongsangbukdo
-
Daegu、Gyeongsangbukdo、韓国、41404
- Kyungpook National University Chilgok Hospital
-
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Seoul Teugbyeolsi
-
Eunpyeonggu、Seoul Teugbyeolsi、韓国、03312
- The Catholic University of Korea, Eunpyeong St Marys Hospital
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Seoul、Seoul Teugbyeolsi、韓国、03722
- Severance Hospital Yonsei University Health System
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
主な採用基準:
- -組織学的または細胞学的に記録された局所進行または再発の非小細胞肺がん（NSCLC）で、化学放射線療法を伴うまたは伴わない根治的手術および/または根治的放射線療法、または転移性非扁平上皮または扁平上皮NSCLCの対象とならない。
- 転移性NSCLCに対する以前の全身治療はありません。
- アーカイブ組織または新鮮な生検を提供することに同意する (アーカイブ組織が利用できない場合)。
- 50%以上の腫瘍細胞でPD-L1が発現している腫瘍。
- -RECIST v1.1に従って定義された少なくとも1つの測定可能な病変。
- ECOGパフォーマンスステータス≤1。
主な除外基準:
- 上皮成長因子受容体 (EGFR) 遺伝子、未分化リンパ腫キナーゼ (ALK) 融合癌遺伝子、BRAF V600E、または ROS1 における既知の変異。
- -抗プログラム細胞死タンパク質（抗PD）-1、抗PDリガンド（L）-1、抗PDリガンド-2、抗T細胞免疫グロブリンおよびITIM（抗TIGIT）による以前の治療ドメイン、または T 細胞共刺激またはチェックポイント経路を特異的に標的とするその他の抗体または薬物。
- -活動性の軟髄膜疾患または制御されていない未治療の脳転移。
- -活動性の自己免疫疾患または再発する可能性のある自己免疫疾患の病歴。
注: 他のプロトコル定義の包含/除外基準が適用される場合があります
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
チスレリズマブは、静脈内注射用に処方されたモノクローナル抗体です。
他の名前：
オシペリマブは、静脈注射用に処方されたモノクローナル抗体です。
他の名前：
|
|
アクティブコンパレータ：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.
|
ペムブロリズマブは、静脈注射用に処方されたモノクローナル抗体です。
他の名前：
プラセボ注入は、無菌の通常の生理食塩水で構成されます。
|
|
プラセボコンパレーター：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.
|
チスレリズマブは、静脈内注射用に処方されたモノクローナル抗体です。
他の名前：
プラセボ注入は、無菌の通常の生理食塩水で構成されます。
|
|
実験的：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.
|
チスレリズマブは、静脈内注射用に処方されたモノクローナル抗体です。
他の名前：
オシペリマブは、静脈注射用に処方されたモノクローナル抗体です。
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall Survival (OS) in Arms A and B
時間枠：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)
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Up to 38.9 months
|
Up to 38.9 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Mark Socinski、Advent Health Orlando
- 主任研究者：Shun Lu、Shanghai Chest Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年5月24日
一次修了 (実際)
2025年5月30日
研究の完了 (実際)
2026年3月18日
試験登録日
最初に提出
2021年2月5日
QC基準を満たした最初の提出物
2021年2月5日
最初の投稿 (実際)
2021年2月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月12日
QC基準を満たした最後の更新が送信されました
2026年4月20日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AdvanTIG-302
- BGB-A317-A1217-302 (その他の識別子：BeiGene)
- CTR20211476/CTR20211464 (その他の識別子：ChinaDrugTrials)
- 2020-004985-21 (EudraCT番号)
- 2023-507317-10-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
See plan description
IPD 共有アクセス基準
See plan description
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。