치료받지 않은 폐암 참가자에서 Pembrolizumab과 Tislelizumab을 병용한 Ociperlimab 연구
2026년 4월 20일 업데이트: BeiGene
이전에 치료받지 않은 PD-L1 선별 환자 및 국소 진행성, 절제 불가능 또는 전이성 비소세포 환자를 대상으로 펨브롤리주맙과 비교한 항TIGIT 항체인 Ociperlimab의 3상, 무작위, 이중맹검 연구 폐암
이 연구의 목적은 고형 종양 버전 1.1의 반응 평가 기준(Response Evaluation Criteria in Solid Tumors Version 1.1)에 따라 연구자가 평가한 A군(tislelizumab과 조합된 ociperlimab)과 Arm B(위약과 조합된 pembrolizumab) 사이의 무진행 생존(PFS)을 비교하는 것입니다. RECIST v1.1) 및 Arm A와 Arm B 사이의 전체 생존(OS)을 비교합니다.
연구 개요
연구 유형
중재적
등록 (실제)
669
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Batumi, 그루지야, 6000
- High Technology Hospital MedCenter Ltd
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Tbilisi, 그루지야, 0186
- Multiprofile Clinic Consilium Medulla Ltd
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Tbilisi, 그루지야, 0159
- Institute of Clinical Oncology Ltd
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Tbilisi, 그루지야, 0112
- Acad Fridon Todua Medical Center Ltd Research Institute of Clinical Medicine Ltd
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Tbilisi, 그루지야, 0112
- Israel Georgian Medical Research Clinic Helsicore Ltd
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Tbilisi, 그루지야, 0119
- Jsc German Hospital
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Tbilisi, 그루지야, 0159
- Jsc Evex Hospitals Tbilisi
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Tbilisi, 그루지야, 0160
- Tim Tbilisi Institute of Medicine Ltd
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Tbilisi, 그루지야, 0186
- Caucasus Medical Centre Ltd
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Tbilisi, 그루지야, 0186
- Oncology Research Center Ltd
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Amersfoort, 네덜란드, 3813 TZ
- Meander Medisch Centrum
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Arnhem, 네덜란드, 6815 AD
- Rijnstate
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Harderwijk, 네덜란드, 3844 DG
- Ziekenhuis St Jansdal
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Heerlen, 네덜란드, 6419 PC
- Stichting Zuyderland Medisch Centrum
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Zwolle, 네덜란드, 8025 AB
- Isala Klinieken Zwolle
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Changhua, 대만, 50006
- Changhua Christian Hospital
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Kaohsiung City, 대만, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Taichung, 대만, 40201
- Chung Shan Medical University Hospital
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Taipei, 대만, 11217
- Taipei Veterans General Hospital
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Taipei, 대만, 231405
- Taipei Tzu Chi Hospital
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Taoyuan, 대만, 33305
- Linkou Chang Gung Memorial Hospital
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Yunlin, 대만, 640
- National Taiwan University Hospital Yunlin Branch
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Chungcheongbukdo
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Cheongju-si, Chungcheongbukdo, 대한민국, 28644
- Chungbuk National University Hospital
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, 대한민국, 42601
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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Bucheon-si, Gyeonggi-do, 대한민국, 14647
- The Catholic University of Korea Bucheon St Marys Hospital
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Gyeonggido, Gyeonggi-do, 대한민국, 13496
- CHA Bundang Medical Center, CHA University
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Suwon, Gyeonggi-do, 대한민국, 16247
- The Catholic University of Korea, St Vincents Hospital
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Gyeongsangbukdo
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Daegu, Gyeongsangbukdo, 대한민국, 41404
- Kyungpook National University Chilgok Hospital
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Seoul Teugbyeolsi
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Eunpyeonggu, Seoul Teugbyeolsi, 대한민국, 03312
- The Catholic University of Korea, Eunpyeong St Marys Hospital
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Seoul, Seoul Teugbyeolsi, 대한민국, 03722
- Severance Hospital Yonsei University Health System
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Aachen, 독일, 52074
- Universitaetsklinikum Aachen
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Bonn, 독일, 53127
- Universitatsklinikum Bonn
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Cologne, 독일, 51109
- Kliniken der Stadt Koeln gGmbH
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Giessen, 독일, 35392
- Uniklinikum Giessen Marburg
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Grohansdorf, 독일, 22927
- LungenClinic Grosshansdorf GmbH
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Hamburg, 독일, 20251
- Ambulantes Krebszentrum Hamburg
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Munich, 독일, 81925
- Munchen Klinik Bogenhausen
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Rotenburg (Wümme), 독일, 27356
- Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige Gmbh
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Arkhangelskaya oblast
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Arkhangelsk, Arkhangelskaya oblast, 러시아 제국, 163045
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Bashkortostan Republic
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Ufa, Bashkortostan Republic, 러시아 제국, 450054
- State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the Republic
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Chelyabinsk Oblast
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Magnitogorsk, Chelyabinsk Oblast, 러시아 제국, 455001
- State Budgetary Healthcare Institution Regional Oncology Dispensary Number
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Moscow
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Moscow, Moscow, 러시아 제국, 121309
- VitaMed LLC
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Nizhny Novgorod Oblast
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Nizhny Novgorod, Nizhny Novgorod Oblast, 러시아 제국, 603081
- State Budgetary Healthcare Institution Nizhny Novgorod Regional Clinical Oncology Dispensary
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Omsk Oblast
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Omsk, Omsk Oblast, 러시아 제국, 644013
- Bih of Omsk Region Clinical Oncology Dispensary
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Samaraskaya Oblast'
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Samara, Samaraskaya Oblast', 러시아 제국, 443031
- State Budgetary Healthcare Institution Samara Regional Clinical Oncology Dispensary
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, 러시아 제국, 197082
- Llc Av Medical Group
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California
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Fullerton, California, 미국, 92835
- Providence Medical Foundation St Jude Heritage Healthcare
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Los Angeles, California, 미국, 90067
- Valkyrie Clinical Trials
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Florida
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Ocala, Florida, 미국, 34474
- Ocala Oncology Center Pl Dba Florida Cancer Affiliates Ocala
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Orlando, Florida, 미국, 32804
- Advent Health Cancer Institute
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Indiana
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Goshen, Indiana, 미국, 46526
- Goshen Center for Cancer Care
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Kentucky
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Lexington, Kentucky, 미국, 40503
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- University Medical Center New Orleans West Jefferson Medical Center
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Minnesota
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Saint Paul, Minnesota, 미국, 55101
- Metro Minnesota Community Oncology Research Consortium (MMCORC)
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15224
- West Penn Hospital
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Brasília, 브라질, 70390140
- Instituto Dor de Pesquisa E Ensino Distrito Federal
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Cachoeiro de Itapemirim, 브라질, 29308-020
- Hospital Evangélico de Cachoeiro de Itapemirim
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Florianópolis, 브라질, 88034-000
- Centro de Pesquisas Oncologicas Cepon
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Fortaleza, 브라질, 60430-235
- Cancer Institute of Ceara
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Santo André, 브라질, 09060-650
- Cepho Centro de Estudos E Pesquisas de Hematologia E Oncologia
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São José do Rio Preto, 브라질, 15090-000
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
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Alcorcón, 스페인, 28922
- Hospital Universitario Fundacion Alcorcon
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Barcelona, 스페인, 08003
- Hospital Del Mar
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Barcelona, 스페인, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, 스페인, 08035
- Hospital Universitario Vall Dhebron
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Barcelona, 스페인, 8028
- Hospital Universitari Quiron Dexeus
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Elche, 스페인, 3203
- Hospital General Universitario de Elche
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Girona, 스페인, 17007
- ICO Girona
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Jaén, 스페인, 23007
- Hospital Universitario de Jaén
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Las Palmas, 스페인, 35016
- Complejo Hospitalario Universitario Insular Gran Canaria
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Lugo, 스페인, 27003
- Hospital Universitario Lucus Augusti
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Madrid, 스페인, 28040
- Hospital Clinico San Carlos
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Madrid, 스페인, 28041
- Hospital Universitario Doce de Octubre
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Madrid, 스페인, 28040
- Start Madrid Fundacion Jimenez Diaz
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Majadahonda, 스페인, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Murcia, 스페인, 30008
- Hospital General Universitario Morales Meseguer
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Málaga, 스페인, 29010
- Hospital Regional Universitario de Málaga
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Málaga, 스페인, 29010
- Hospital Universitario Virgen de la Victoria
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Ourense, 스페인, 32005
- Complexo Hospitalario Universitario de Ourense
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Palma de Mallorca, 스페인, 07120
- Hospital Universitari Son Espases
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Seville, 스페인, 41013
- Hospital Universitario Virgen del Rocío
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Seville, 스페인, 41014
- Hospital Universitario Nuestra Señora de Valme
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Valencia, 스페인, 46026
- Hospital Universitari i Politecnic La Fe
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Valencia, 스페인, 46015
- Hospital Arnau de Vilanova
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Buenos Aires, 아르헨티나, 1409
- Centro Medical Austral
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San Miguel de Tucumán, 아르헨티나, 4000
- Centro Para La Atencion Del Paciente Oncologico (Caipo)
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Kryvyi Rih, 우크라이나, 50000
- Medical Center of Limited Liability Company Mriya Med Service
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Uzhhorod, 우크라이나, 88000
- Communal Non Profit Enterprisecentral Municipal Clinical Hospital of Uzhhorod City Council
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Uzhhorod, 우크라이나, 88011
- Zakarpatska Regional Clinical Oncological Center
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Bologna, 이탈리아, 40138
- Azienda Ospedaliera Universitaria Policlinico Santorsola Malpighi
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Messina, 이탈리아, 98158
- Azienda Ospedaliera Papardo
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Orbassano, 이탈리아, 10043
- AOU San Luigi Gonzaga
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Hiroshima, 일본, 734-8551
- Hiroshima University Hospital
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Niigata, 일본, 951-8566
- Niigata Cancer Center Hospital
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Aichi-ken
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Nagoya, Aichi-ken, 일본, 466-8560
- Nagoya University Hospital
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Aomori
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Hirosaki, Aomori, 일본, 036-8563
- Hirosaki University Hospital
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Ehime
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Matsuyama, Ehime, 일본, 791-0280
- NHO Shikoku Cancer Center
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Fukuoka
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Kurume, Fukuoka, 일본, 830-0011
- Kurume University Hospital
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Gunma
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Shibukawa, Gunma, 일본, 337-0280
- National Hospital Organization Shibukawa Medical Center
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Hyōgo
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Kobe, Hyōgo, 일본, 650-0017
- Kobe University Hospital
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Kobe, Hyōgo, 일본, 650-0047
- Kobe City Medical Center General Hospital
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Nishinomiyashi, Hyōgo, 일본, 663-8501
- Hyogo Medical University Hospital
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Ishikawa-ken
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Kanazawa, Ishikawa-ken, 일본, 920-8641
- Kanazawa University Hospital
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Kanagawa
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Yokohama, Kanagawa, 일본, 241-8515
- Kanagawa Cancer Center
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Miyagi
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Natorishi, Miyagi, 일본, 981-1293
- Miyagi Cancer Center
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Okayama-ken
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Okayama, Okayama-ken, 일본, 700-8558
- Okayama University Hospital
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Osaka
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Hirakata, Osaka, 일본, 573-1191
- Kansai Medical University Hospital
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Sakai, Osaka, 일본, 591-8555
- National Hospital Organization Kinki Chuo Chest Medical Center
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Sayama, Osaka, 일본, 589-8511
- Kindai University Hospital
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Toyonaka, Osaka, 일본, 560-8552
- Osaka Toneyama Medical Center
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Tochigi
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Shimonotsuke, Tochigi, 일본, 329-0498
- Jichi Medical University Hospital
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Shimotsugagun, Tochigi, 일본, 321-0293
- Dokkyo Medical University Hospital
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Utsunomiya, Tochigi, 일본, 320-0834
- Tochigi Cancer Center
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Tokyo
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Bunkyoku, Tokyo, 일본, 113-8603
- Nippon Medical School Hospital
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Kotoku, Tokyo, 일본, 135-8550
- Cancer Institute Hospital of JFCR
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Anhui
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Hefei, Anhui, 중국, 230601
- The Second Hospital of Anhui Medical University
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Hefei, Anhui, 중국, 230000
- Anhui Provincial Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, 중국, 100730
- Peking Union Medical College Hospital
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Beijing, Beijing Municipality, 중국, 100020
- Beijing Chao Yang Hospital
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Beijing, Beijing Municipality, 중국, 101149
- Beijing Chest Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, 중국, 400030
- Chongqing Cancer Hospital
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Chongqing, Chongqing Municipality, 중국, 400042
- Daping Hospital, Third Military Medical University
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Chongqing, Chongqing Municipality, 중국, 400038
- The First Affiliated Hospital of Army Military Medical University
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Chongqing, Chongqing Municipality, 중국, 404000
- Chongqing University Three Gorges Central Hospital
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Fujian
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Fuzhou, Fujian, 중국, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Fujian, 중국, 350014
- Fujian Cancer Hospital
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Xiamen, Fujian, 중국, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, 중국, 510030
- Affiliated Cancer Hospital and institute of Guangzhou Medical University
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Shantou, Guangdong, 중국, 515031
- Cancer Hospital of Shantou University Medical College
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Shenzhen, Guangdong, 중국, 518020
- Shenzhen Peoples Hospital
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Guangxi
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Nanning, Guangxi, 중국, 530021
- The Peoples Hospital of Guangxi Zhuang Autonomous Region
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Nanning, Guangxi, 중국, 530021
- The Tumor Hospital Affiliated to Guangxi Medical University
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Heilongjiang
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Harbin, Heilongjiang, 중국, 150000
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, 중국, 450052
- The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, 중국, 450000
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, 중국, 430079
- Hubei Cancer Hospital
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Wuhan, Hubei, 중국, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Hubei, 중국, 430022
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, 중국, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, 중국, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Changzhou, Jiangsu, 중국, 213003
- Changzhou No Peoples Hospital, the Affiliated Hospital of Nanjing Medical University Branch Cheng
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Nanjing, Jiangsu, 중국, 210029
- Nanjing Chest Hospital
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Nanjing, Jiangsu, 중국, 210009
- Nanjing First Hospital
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Suzhou, Jiangsu, 중국, 215000
- The Second Affiliated Hospital of Soochow University
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Suzhou, Jiangsu, 중국, 215006
- The First Affiliated Hospital of Soochow University Branch Shizi
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Xuzhou, Jiangsu, 중국, 221000
- Xuzhou Central Hospital
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Liaoning
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Shenyang, Liaoning, 중국, 110042
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, 중국, 710061
- The First Affiliated Hospital of Xian Jiaotong University
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Shandong
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Qingdao, Shandong, 중국, 266000
- The Affiliated Hospital of Qingdao University Branch Laoshan
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Weifang, Shandong, 중국, 261000
- Weifang Peoples Hospital
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Yantai, Shandong, 중국, 264000
- Yantai YuHuangDing Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200433
- Shanghai Pulmonary Hospital
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Shanghai, Shanghai Municipality, 중국, 200030
- Shanghai Chest Hospital
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Shanghai, Shanghai Municipality, 중국, 200032
- Affiliated Zhongshan Hospital of Fudan University
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Shanxi
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Taiyuan, Shanxi, 중국, 030032
- Shanxi Bethune Hospital
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Sichuan
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Chengdu, Sichuan, 중국, 610041
- West China Hospital, Sichuan University
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Chengdu, Sichuan, 중국, 610041
- Sichuan Cancer Hospital and Institute
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Nanchong, Sichuan, 중국, 637000
- Affiliated Hospital of North Sichuan Medical College
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Tianjin Municipality
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Tianjin, Tianjin Municipality, 중국, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Tianjin, Tianjin Municipality, 중국, 300052
- Tianjin Medical University General Hospital
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Xinjiang
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Ürümqi, Xinjiang, 중국, 830000
- Affiliated Cancer Hospital of Xinjiang Medical University
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, 중국, 310016
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
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Ningbo, Zhejiang, 중국, 315010
- The First Affiliated Hospital of Ningbo University
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Taizhou, Zhejiang, 중국, 317000
- Taizhou Hospital of Zhejiang
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Yiwu, Zhejiang, 중국, 322000
- The Fourth Affiliated Hospital Zhejiang University School of Medicine
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Bangkok, 태국, 10700
- Siriraj Hospital
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Hat Yai, 태국, 90110
- Songklanagarind Hospital (Prince of Songkhla University)
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Lak Si, 태국, 10210
- Chulabhorn Research Institute
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Muang, 태국, 50200
- Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
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Muang, 태국, 40002
- Srinagarind Hospital (Khon Kaen University)
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Ratchathewi, 태국, 10400
- Phramongkutklao Hospital
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Ratchathewi, 태국, 10400
- Rajavithi Hospital
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Adana, 터키 (Türkiye), 01130
- Acibadem Adana Hospital
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Adana, 터키 (Türkiye), 1240
- Baskent University Practice and Research Hospital Adana Medical Oncology Department
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Ankara, 터키 (Türkiye), 6520
- Memorial Ankara Hospital
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Ankara, 터키 (Türkiye), 06200
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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Battalgazi, 터키 (Türkiye), 44280
- Inonu Universitesi Tip Fakultesi
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Edirne, 터키 (Türkiye), 22030
- Tr Trakya University Health Research and Application Center (Hospital)
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Istanbul, 터키 (Türkiye), 34098
- Iu C, Clinical Research Excellence Application and Research Center
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Istanbul, 터키 (Türkiye), 34722
- Tr Ministry of Health Goztepe Prof Dr Suleyman Yalcin City Hospital
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Izmir, 터키 (Türkiye), 35100
- Ege University Medical Faculty
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Kocaeli, 터키 (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi
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Meram, 터키 (Türkiye), 42090
- Necmettin Erbakan University Selcuklu Faculty of Medicine
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Mersin City Hospital, 터키 (Türkiye), 33240
- Mersin City Hospital
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Bialystok, 폴란드, 15-276
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Lodz, 폴란드, 93-510
- Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lodz, 폴란드, 90-338
- Centrum Terapii Wspoczesnej
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Poznan, 폴란드, 60-569
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii
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Poznan, 폴란드, 60-693
- Przychodnia Med Polonia Sp Z Oo
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Zamość, 폴란드, 22-400
- ETG Zamość
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Bayonne, 프랑스, 64100
- Centre Hospitalier de La Cote Basque Saint Leon Service de Pneumologie
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Bordeaux, 프랑스, 33076
- Centre de Lutte Contre Le Cancer Institut Bergonie
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Lyon, 프랑스, 69317
- Hôpital de La Croix Rousse
-
Lyon, 프랑스, 69500
- Hopital Louis Pradel
-
Montpellier, 프랑스, 24298
- Icm Val Daurelle Oncologie Medicale
-
Nancy, 프랑스, 54100
- Polyclinique de Gentilly
-
Paris, 프랑스, 75014
- Hôpital Cochin
-
PierreBenite, 프랑스, 69495
- Chu Hopital Lyon Sud
-
Saint-Mandé, 프랑스, 94160
- HIA Begin
-
Saint-Pierre, 프랑스, 97448
- CHU de la Réunion
-
SaintHerblain, 프랑스, 44805
- Centre de Lutte Contre Le Cancer Institut de Cancerologie de Louest Rene Gauducheau
-
SaintHerblain, 프랑스, 44805
- CHU Nantes Hopital Nord Laennec
-
Tours, 프랑스, 37000
- Chu Tours Hopital Bretonneau Service Pneumologie
-
-
-
-
New South Wales
-
Concord, New South Wales, 호주, 2139
- Concord Repatriation General Hospital
-
St Leonards, New South Wales, 호주, 2065
- Northern Cancer Institute
-
Waratah, New South Wales, 호주, 2298
- Calvary Mater Newcastle
-
-
Queensland
-
Benowa, Queensland, 호주, 4217
- Pindara Private Hospital
-
Chermside, Queensland, 호주, 4032
- The Prince Charles Hospital
-
South Brisbane, Queensland, 호주, 4101
- Mater Cancer Care Centre
-
Tugun, Queensland, 호주, 4224
- John Flynn Private Hospital
-
-
South Australia
-
Elizabeth Vale, South Australia, 호주, 5112
- Lyell McEwin Hospital
-
-
Victoria
-
Ballarat, Victoria, 호주, 3350
- Ballarat Health Services
-
Clayton, Victoria, 호주, 3168
- Monash Health
-
St Albans, Victoria, 호주, 3021
- Western Health Sunshine Hospital
-
-
Western Australia
-
Murdoch, Western Australia, 호주, 6150
- St John of God, Murdoch
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
주요 포함 기준:
- 조직학적 또는 세포학적으로 기록된 국소 진행성 또는 재발성 비소세포폐암(NSCLC)은 화학방사선요법을 포함하거나 포함하지 않는 완치 수술 및/또는 최종 방사선요법 또는 전이성 비편평 또는 편평 NSCLC에 적합하지 않습니다.
- 전이성 NSCLC에 대한 사전 전신 치료가 없습니다.
- 보관 조직 또는 신선한 생검 제공에 대한 동의(보관 조직을 사용할 수 없는 경우).
- PD-L1이 있는 종양은 50% 이상의 종양 세포에서 발현됩니다.
- RECIST v1.1에 따라 정의된 최소 1개의 측정 가능한 병변.
- ECOG 수행 상태 ≤ 1.
주요 제외 기준:
- 표피 성장 인자 수용체(EGFR) 유전자, 역형성 림프종 키나아제(ALK) 융합 종양 유전자, BRAF V600E 또는 ROS1의 알려진 돌연변이.
- 항프로그래밍된 세포사 단백질(anti-PD)-1, 항PD-리간드(L)-1, 항PD-리간드-2, 항T세포 면역글로불린 및 ITIM(anti-TIGIT)을 사용한 선행 요법 도메인, 또는 T-세포 동시자극 또는 체크포인트 경로를 특이적으로 표적화하는 임의의 다른 항체 또는 약물.
- 활동성 연수막 질환 또는 조절되지 않고 치료되지 않은 뇌 전이.
- 활동성 자가면역 질환 또는 재발할 수 있는 자가면역 질환의 병력.
참고: 다른 프로토콜 정의 포함/제외 기준이 적용될 수 있습니다.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
Tislelizumab은 정맥 주사용으로 제조된 단클론 항체입니다.
다른 이름들:
Ociperlimab은 정맥 주사용으로 제조된 단클론 항체입니다.
다른 이름들:
|
|
활성 비교기: 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.
|
Pembrolizumab은 정맥 주사용으로 제조된 단클론 항체입니다.
다른 이름들:
위약 주입은 멸균된 일반 식염수로 구성됩니다.
|
|
위약 비교기: 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.
|
Tislelizumab은 정맥 주사용으로 제조된 단클론 항체입니다.
다른 이름들:
위약 주입은 멸균된 일반 식염수로 구성됩니다.
|
|
실험적: 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.
|
Tislelizumab은 정맥 주사용으로 제조된 단클론 항체입니다.
다른 이름들:
Ociperlimab은 정맥 주사용으로 제조된 단클론 항체입니다.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS) in Arms A and B
기간: 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)
기간: 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
기간: 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.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-free Survival (PFS) for Arm A Versus Arm B As Assessed By the Investigator
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 38.9 months
|
Up to 38.9 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Mark Socinski, Advent Health Orlando
- 수석 연구원: Shun Lu, Shanghai Chest Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 5월 24일
기본 완료 (실제)
2025년 5월 30일
연구 완료 (실제)
2026년 3월 18일
연구 등록 날짜
최초 제출
2021년 2월 5일
QC 기준을 충족하는 최초 제출
2021년 2월 5일
처음 게시됨 (실제)
2021년 2월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 20일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AdvanTIG-302
- BGB-A317-A1217-302 (기타 식별자: BeiGene)
- CTR20211476/CTR20211464 (기타 식별자: ChinaDrugTrials)
- 2020-004985-21 (EudraCT 번호)
- 2023-507317-10-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
See plan description
IPD 공유 액세스 기준
See plan description
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .