국소적으로 진행되고 절제 불가능한 3기 비소세포폐암(NSCLC) 참가자를 대상으로 한 아테졸리주맙 및 티라골루맙과 더발루맙의 비교 연구 (SKYSCRAPER-03)
2026년 5월 7일 업데이트: Hoffmann-La Roche
동시 백금 기반 화학방사선 요법 후 진행되지 않은 국소적으로 진행되고 절제 불가능한 III기 비소세포폐암 환자에서 Durvalumab과 비교한 Atezolizumab 및 Tiragolumab의 III상, 공개, 무작위 연구
이 연구의 목적은 최소 2주기의 동시 백금-백금 요법을 받은 국소 진행성 절제 불가능한 III기 비소세포폐암(NSCLC) 참가자를 대상으로 두르발루맙과 비교하여 티라골루맙과 병용한 아테졸리주맙의 효능 및 안전성을 평가하는 것입니다. 기반 화학방사선 요법(CRT) 및 방사선학적 질병 진행이 없었습니다.
연구 개요
연구 유형
중재적
등록 (실제)
829
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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Asvestochóri, 그리스, 570 10
- General Hospital "G.Papanikolaou"
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Athens, 그리스, 11527
- Sotiria Hospital
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Kifissia, 그리스, 145 64
- Agioi Anargyroi Cancer Hospital
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Amersfoort, 네덜란드, 3813 TZ
- Meander Medisch Centrum
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Breda, 네덜란드, 4819 EV
- Amphia Ziekenhuis
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Leidschendam, 네덜란드, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
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Sittard-Geleen, 네덜란드, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
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Auckland, 뉴질랜드, 1023
- Auckland City Hospital, Cancer and Blood Research
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Taichung, 대만, 40447
- China Medical University Hospital
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Taipei, 대만, 112
- Taipei Veterans General Hospital
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Cheongju-si, 대한민국, 28644
- Chungbuk National University Hospital
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Daegu, 대한민국, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, 대한민국, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, 대한민국, 16247
- St. Vincent's Hospital
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Gyeonggi-do, 대한민국, 10408
- National Cancer Center
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Gyeonggi-do, 대한민국, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, 대한민국, 50612
- Pusan National University Yangsan Hospital
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Incheon, 대한민국, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, 대한민국, 58128
- Chonnam National University Hwasun Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 05505
- Asan Medical Center
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Seoul, 대한민국, 06351
- Samsung Medical Center
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Seoul, 대한민국, 08308
- Korea University Guro Hospital
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Seoul, 대한민국, 06591
- Seoul St Mary's Hospital
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Ulsan, 대한민국, 44033
- Ulsan University Hosiptal
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Braunschweig, 독일, 38114
- Klinikum Braunschweig
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Cologne, 독일, 51109
- Klinikum Koeln-Merheim
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Göttingen, 독일, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, 독일, 69126
- Thoraxklinik Heidelberg gGmbH
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München, 독일, 81925
- Klinikum Bogenhausen
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Regensburg, 독일, 93053
- Universitätsklinikum Regensburg
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California
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Palo Alto, California, 미국, 94305
- Stanford University
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Colorado
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Greeley, Colorado, 미국, 80631
- Banner MD Anderson Cancer Center
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Florida
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Fort Myers, Florida, 미국, 33901-8101
- Florida Cancer Specialists
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Palm Bay, Florida, 미국, 32901
- Cancer Care Centers of Brevard
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Pensacola, Florida, 미국, 32503
- Woodlands Medical Specialists, P.A.
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St. Petersburg, Florida, 미국, 33705
- Florida Cancer Specialist, North Region
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Georgia
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Marietta, Georgia, 미국, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, 미국, 61615
- Illinois Cancer Care
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Maine
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Brunswick, Maine, 미국, 04011
- New England Cancer Specialists
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Massachusetts
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Fairhaven, Massachusetts, 미국, 02719
- Southcoast Health System
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Minnesota
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Minneapolis, Minnesota, 미국, 55404
- Minnesota Oncology Hematology
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Missouri
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Kansas City, Missouri, 미국, 64132
- HCA Midwest Health
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Springfield, Missouri, 미국, 65807
- Cox Health Systems
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Nevada
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Las Vegas, Nevada, 미국, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, 미국, 89106
- Optum Health Care
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New Jersey
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East Brunswick, New Jersey, 미국, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
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New Mexico
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Farmington, New Mexico, 미국, 87401
- San Juan Oncology Associates
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New York
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Albany, New York, 미국, 12208
- New York Oncology Hematology,P.C.-Albany
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New York, New York, 미국, 10029
- Mount Sinai Medical Center
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The Bronx, New York, 미국, 10461
- Montefiore Medical Center
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South Carolina
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Greenville, South Carolina, 미국, 29615
- Prisma Health ? Upstate
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Tennessee
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Chattanooga, Tennessee, 미국, 37403
- Tennessee Oncology Chattanooga
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Nashville, Tennessee, 미국, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Virginia
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Fairfax, Virginia, 미국, 22031
- Virginia Cancer Specialists
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Norfolk, Virginia, 미국, 23502
- Virginia Oncology Associates
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Charleroi, 벨기에, 6000
- GHdC Site Les Viviers
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Ghent, 벨기에, 9000
- AZ Maria Middelares
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Hasselt, 벨기에, 3500
- Jessa Zkh (Campus Virga Jesse)
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Ceará
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Fortaleza, Ceará, 브라질, 60336-550
- CRIO - Centro Regional Integrado de Oncologia
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Paraná
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Curitiba, Paraná, 브라질, 80810-050
- Centro Integrado de Oncologia de Curitiba
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Rio Grande do Sul
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Ijuí, Rio Grande do Sul, 브라질, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, 브라질, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, 브라질, 14784-400
- Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, 브라질, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, 브라질, 01246-000
- Instituto do Câncer do Estado de São Paulo - ICESP
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A Coruña, 스페인, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
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Madrid, 스페인, 28046
- Hospital Universitario La Paz
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Madrid, 스페인, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, 스페인, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, 스페인, 41013
- Hospital Universitario Virgen del Rocío
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Seville, 스페인, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, 스페인, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, 스페인, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, 스페인, 12002
- Hospital Provincial de Castellon
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Buenos Aires, 아르헨티나, C1431FWO
- CEMIC
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Ciudad Autonoma Buenos Aires, 아르헨티나, C1284AEB
- Hospital Británico de Buenos Aires
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Córdoba, 아르헨티나, X5004FHP
- Clínica Universitaria Reina Fabiola
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Rosario, 아르헨티나, S2000QGB
- Sanatorio Parque S.A.
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Birmingham, 영국, B9 5SS
- Birmingham Heartlands Hospital
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Cambridge, 영국, CB2 0QQ
- Addenbrooke's NHS Trust
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Glasgow, 영국, G12 0YN
- Beatson West of Scotland Cancer Centre
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Huddersfield, 영국, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
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Leicester, 영국, LE1 5WW
- Leicester Royal Infirmary
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Maidstone, 영국, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
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Manchester, 영국, M20 4BX
- Christie Foundation Trust
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Sheffield, 영국, S10 2SJ
- Weston Park Hospital
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Innsbruck, 오스트리아, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, 오스트리아, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, 오스트리아, 1140
- Klinik Penzing
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Beersheba, 이스라엘, 8410100
- Soroka Medical Center
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Haifa, 이스라엘, 3109601
- Rambam Medical Center
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Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, 이스라엘, 4941492
- Rabin Medical Center
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Campania
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Naples, Campania, 이탈리아, 80131
- Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
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Emilia-Romagna
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Meldola, Emilia-Romagna, 이탈리아, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Parma, Emilia-Romagna, 이탈리아, 43100
- Azienda Ospedaliero Universitaria di Parma
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Lazio
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Rome, Lazio, 이탈리아, 00128
- Policlinico Universitario Campus Biomedico
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Rome, Lazio, 이탈리아, 00144
- IRCCS Istituto Regina Elena (IFO)
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Liguria
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Genoa, Liguria, 이탈리아, 16132
- IRCCS AOU San Martino - IST
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Lombardy
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Brescia, Lombardy, 이탈리아, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
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Milan, Lombardy, 이탈리아, DUMMY_VALUE
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Pavia, Lombardy, 이탈리아, 27100
- Fondazione IRCCS Policlinico San Matteo
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Tuscany
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Pisa, Tuscany, 이탈리아, 56124
- Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
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Veneto
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Vicenza, Veneto, 이탈리아, 36100
- Azienda ULSS 8 Berica
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Aichi, 일본, 464-8681
- Aichi Cancer Center
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Chiba, 일본, 277-8577
- National Cancer Center East
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Hyōgo, 일본, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, 일본, 252-0375
- Kitasato University Hospital
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Kyoto, 일본, 606-8507
- Kyoto University Hospital
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Miyagi, 일본, 981-0914
- Sendai Kousei Hospital
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Niigata, 일본, 951-8566
- Niigata Cancer Center Hospital
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Osaka, 일본, 589-8511
- Kindai University Hospital
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Saitama, 일본, 362-0806
- Saitama Cancer Center
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Shizuoka, 일본, 411-8777
- Shizuoka Cancer Center
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Tokyo, 일본, 104-0045
- National Cancer Center Hospital
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Tokyo, 일본, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, 일본, 641-8510
- Wakayama Medical University Hospital
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Beijing, 중국, 101149
- Beijing Chest Hospital
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Beijing, 중국, 100142
- Beijing Cancer Center
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Changchun, 중국, 132013
- Jilin cancer hospital
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Changsha, 중국, 410008
- Xiangya Hospital Central South University
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Chengdu, 중국, 610041
- Sichuan Provincial Cancer Hospital
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Chongqing, 중국, 400030
- Chongqing Cancer Hospital
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Fujian, 중국, 350001
- Fujian Medical University Union Hospital
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Fuzhou, 중국, 350014
- Fujian Provincial Cancer Hospital
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Guangzhou, 중국, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, 중국, 310002
- Hangzhou Cancer Hospital
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Jinan, 중국, 250117
- Shandong Cancer Hospital
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Nanjing, 중국, 210009
- Zhongda Hospital Affiliated to Southeast University
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Qingdao, 중국, 266042
- The Affiliated Hospital of Qingdao University
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Shanghai, 중국, 200000
- Shanghai Chest Hospital
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Shantou, 중국, 515041
- Cancer Hospital of Shantou University Medical College
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Taiyuan, 중국, 030013
- Shanxi Provincial Cancer Hospital
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Tianjin, 중국, 300060
- Tianjin Cancer Hospital
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Wenzhou, 중국, 325000
- The 2nd School of Medicine, WMU
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Xiamen, 중국, 361003
- The First Affiliated Hospital of Xiamen University
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Xuzhou, 중국, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Zhengzhou, 중국, 450008
- Henan Cancer Hospital
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British Columbia
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Abbotsford British Columbia, British Columbia, 캐나다, V2S 0C2
- BC Cancer ? Abbotsford
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Victoria, British Columbia, 캐나다, V8R 6V5
- BC Cancer - Victoria
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Ontario
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Barrie, Ontario, 캐나다, L4M 6M2
- Royal Victoria Regional Health Centre
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Brampton, Ontario, 캐나다, L6R 3J7
- William Osler Health System Brampton Civic Hospital
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Ottawa, Ontario, 캐나다, K1H 8L6
- Ottawa Hospital Research Institute
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Bangkok, 태국, 10400
- Rajavithi Hospital
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Bangkok, 태국, 10300
- Vajira Hospital
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Bangkok, 태국, 10400
- Ramathibodi Hospital;Medicine/Oncology
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Songkhla, 태국, 90110
- Songklanagarind Hospital
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Adana, 터키 (Türkiye), 01220
- Adana Baskent University Medical Faculty
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Ankara, 터키 (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, 터키 (Türkiye), 06100
- Ankara University Medical Faculty
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Ankara, 터키 (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, 터키 (Türkiye), 35100
- Ege University Medical Faculty
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Diyarbakır, 터키 (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, 터키 (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, 터키 (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, 터키 (Türkiye), 34214
- Medipol University Medical Faculty
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Malatya, 터키 (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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Coimbra, 포르투갈, 3000-075
- IPO de Coimbra
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Lisbon, 포르투갈, 1500-650
- Hospital da Luz
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Porto, 포르투갈, 4100-180
- Hospital CUF Porto
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Porto, 포르투갈, 4200-072
- IPO do Porto
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Gda?sk, 폴란드, 80-214
- Uniwersyteckie Centrum Kliniczne
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Olsztyn, 폴란드, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
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Otwock, 폴란드, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Warsaw, 폴란드, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
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Wroc?aw, 폴란드, 53-413
- Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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Angers, 프랑스, 49933
- CHU Angers
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Caen, 프랑스, 14000
- Centre François Baclesse
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Marseille, 프랑스, 13015
- Hopital Nord AP-HM
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Montpellier, 프랑스, 34070
- Clinique Clementville
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Vantoux, 프랑스, 57070
- Hôpital Robert Schuman
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Villejuif, 프랑스, 94805
- Institut Gustave Roussy
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Pécs, 헝가리, 7623
- Pecsi Tudomanyegyetem
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Tatabánya, 헝가리, 2800
- Szent Borbala Korhaz
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Törökbálint, 헝가리, 2045
- Tudogyogyintezet Torokbalint
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New South Wales
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Blacktown, New South Wales, 호주, 2148
- Blacktown Hospital
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Campbelltown, New South Wales, 호주, 2560
- Macarthur Cancer Therapy Centre
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Kogarah, New South Wales, 호주, 2217
- St George Hospital
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South Australia
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Bedford Park, South Australia, 호주, 5042
- Flinders Medical Centre
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Victoria
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Victoria, Victoria, 호주, 3168
- Monash Health Translational Precinct
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Western Australia
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Bull Creek, Western Australia, 호주, 6149
- Fiona Stanley Hospital
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Hong Kong, 홍콩
- Tuen Mun Hospital
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Hong Kong, 홍콩
- Pamela Youde Nethersole Eastern Hospital
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Hong Kong, 홍콩, DUMMY_VALUE
- Queen Elizabeth Hospital
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Hong Kong, 홍콩, DUMMY_VALUE
- Princess Margaret Hospital, Oncology
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Pokfulam, 홍콩, DUMMY_VALUE
- Queen Mary Hospital
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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
포함 기준:
- 동부 협력 종양학 그룹(ECOG) 수행 상태 0 또는 1
- 편평 조직 또는 비편평 조직학의 절제 불가능한 국소 진행성 III기 NSCLC를 동반한 조직학적 또는 세포학적으로 기록된 NSCLC
- 전신 양전자 방출 단층촬영-컴퓨터 단층촬영(PET-CT) 스캔, 동시 화학방사선요법(cCRT)의 첫 번째 투여 전 및 42일 이내에 수행
- 연구에서 무작위 배정 전 1일 내지 42일 이내에 완료되어야 하는 방사선 요법(RT)과 동시에 투여된 백금 기반 화학 요법의 이전 주기가 최소 2회 이상(cCRT의 한 주기는 21일 또는 28일로 정의됨)
- cCRT의 방사선 요법(RT) 구성 요소는 강도 변조 RT(선호) 또는 3D- 적합 기술
- 동시 백금 기반 CRT 중 또는 이후 진행 없음
- 알려진 PD-L1 결과
- 기대 수명 >/= 12주
- 적절한 혈액학적 및 말단 장기 기능
- 여성 참여자는 티라골루맙 최종 투여 후 90일 및 아테졸리주맙 최종 투여 후 5개월 또는 더발루맙 최종 투여 후 3개월 동안 임신을 피하려는 의지가 있어야 합니다.
- 남성 참여자는 치료 기간 동안 및 티라골루맙 최종 투여 후 90일 동안 금욕을 유지하거나 콘돔을 사용해야 합니다.
- 남성 참가자는 치료 기간 및 티라골루맙 최종 투여 후 90일 동안 정자를 기증해서는 안 됩니다.
제외 기준:
- 이전 NSCLC의 병력 및/또는 NSCLC에 대한 이전 치료의 병력(참가자는 절제 불가능한 3기 질환으로 새로 진단되어야 함)
- 표피 성장 인자 수용체(EGFR) 유전자 또는 역형성 림프종 키나아제(ALK) 융합 종양유전자에 돌연변이가 있는 것으로 알려진 NSCLC
- IV기 질병의 모든 증거
- 국소 진행성 NSCLC에 대한 순차적 CRT 치료
- 무작위 배정 전 최종 cCRT 도중 또는 이후에 진행된 국소 진행성 NSCLC 참가자
- 모든 등급 >2 이전 CRT에서 해결되지 않은 독성
- 이전 CRT에서 등급 >= 2 폐렴
- 자가면역 질환 또는 면역 결핍의 활성 또는 병력
- 특발성 폐섬유증, 조직성 폐렴, 약물 유발성 폐렴 또는 특발성 폐렴의 병력 또는 활동성 폐렴의 증거
- 전이 또는 사망 위험이 무시할 수 있는 악성 종양을 제외하고 스크리닝 전 5년 이내에 NSCLC 이외의 악성 종양 이력
- 이전 동종 줄기 세포 또는 고형 장기 이식
- 활동성 엡스타인-바 바이러스(EBV) 감염 또는 스크리닝 시 알려진 또는 의심되는 만성 활동성 EBV 감염
- 연구 치료 시작 전 28일 이내에 연구 요법으로 치료
- 항세포독성 T 림프구 관련 단백질 4, Ig 및 ITIM 도메인(항-TIGIT)을 포함하는 항-T 세포 면역 수용체, 항-PD-1 및 항-PD-L1을 포함한 CD137 작용제 또는 면역 체크포인트 차단 요법으로 사전 치료
- 이전 등급 >/= 3 면역 매개 이상 반응 또는 면역 체크포인트 차단제 이외의 이전 면역 요법제를 투여받는 동안 해결되지 않은 등급 > 1 면역 매개 이상 반응
- 전신 면역억제제로 치료
- 임신 중이거나 모유 수유 중인 여성
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: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 아테졸리주맙 + 티라골루맙
참가자는 최대 13주기 동안 각 28일 주기의 1일차에 아테졸리주맙을 정맥주사(IV)한 후 각 28일 주기의 1일차에 티라골루맙을 정맥주사합니다.
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아테졸리주맙 1680mg을 4주마다(Q4W) 각 28일 주기의 제1일에 IV 투여합니다.
다른 이름들:
Tiragolumab 840 mg Q4W는 각 28일 주기의 1일에 IV로 투여됩니다.
다른 이름들:
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활성 비교기: 더발루맙
참가자는 최대 13주기 동안 각 28일 주기 동안 IV 투여된 Durvalumab을 받게 됩니다.
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Durvalumab은 각 28일 주기의 1일과 15일에 2주마다(Q2W) 체중을 기준으로 10mg/kg IV로 투여하거나, 4주마다(Q4W) 1500mg의 고정 용량으로 정맥 투여합니다. 각 28일 주기의 1일차에 체중이 >/= 30kg인 참가자의 경우).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
기간: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions.
Kaplan-Meier (K-M) method was used to estimate median PFS.
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From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
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PFS, as Assessed by an IRF in FAS
기간: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
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From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Survival (OS) in PPAS
기간: From randomization to death from any cause (up to approximately 57 months)
|
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
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From randomization to death from any cause (up to approximately 57 months)
|
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PFS, as Assessed by the Investigator in PPAS
기간: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
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From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
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Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS
기간: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesion & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
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Up to approximately 57 months
|
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Confirmed ORR, as Assessed by the Investigator in PPAS
기간: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
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Up to approximately 57 months
|
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Duration of Response (DOR), as Assessed by an IRF in PPAS
기간: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
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From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
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DOR, as Assessed by the Investigator in PPAS
기간: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
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From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
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Time to Confirmed Deterioration (TTCD) in Cough, as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) in PPAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first confirmed clinically meaningful deterioration (CCMD) on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Cough scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
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Up to approximately 57 months
|
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TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
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TTCD in Global Health Status (GHS)/Quality-of-life (QoL), as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Core-30 (EORTC QLQ-C30) in PPAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent.
Scores were linearly transformed to a score range of 0-100.
High score for GHS/QoL scale=better health-related quality-of-life (HRQoL).
CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments/initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
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TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to a score range of 0-100.
High score for PF=high/healthy level of functioning.
CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
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OS in FAS
기간: From randomization to death from any cause (up to approximately 57 months)
|
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate median OS.
|
From randomization to death from any cause (up to approximately 57 months)
|
|
PFS, as Assessed by the Investigator in FAS
기간: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
Confirmed ORR, as Assessed by an IRF in FAS
기간: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
Confirmed ORR, as Assessed by the Investigator in FAS
기간: Up to approximately 57 months
|
ORR was defined as the percentage of participants who achieved an OR, characterized by a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
Percentages have been rounded off.
|
Up to approximately 57 months
|
|
DOR, as Assessed by an IRF in FAS
기간: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
DOR, as Assessed by the Investigator in FAS
기간: From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level.
Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm.
PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
Median DOR was estimated using the K-M method.
|
From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Cough was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication.
Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to score range of 0-100.
High symptom score=high level of symptom severity.
CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent.
Scores were linearly transformed to a score range of 0-100.
High score for GHS/QoL scale=better HRQoL.
CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS
기간: Up to approximately 57 months
|
TTCD=time from randomization until first CCMD on each respective score.
EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties).
PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much.
Scores were linearly transformed to a score range of 0-100.
High score for PF=high/healthy level of functioning.
CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks.
K-M method was used to estimate median TTCD.
|
Up to approximately 57 months
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS
기간: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS
기간: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate median PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
OS Rate at 12, 24, 36, and 48 Months in PPAS
기간: At Months 12, 24, 36, and 48
|
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints.
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate OS rate.
Percentages have been rounded off.
|
At Months 12, 24, 36, and 48
|
|
Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS
기간: Up to approximately 57 months
|
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first.
Distant metastasis was defined as any new lesion that was outside of the radiation field.
K-M method was used to estimate median TTDM.
|
Up to approximately 57 months
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS
기간: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in FAS
기간: At Months 12, 18, and 24
|
PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first.
PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline).
Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions.
K-M method was used to estimate PFS rate.
Percentages have been rounded off.
|
At Months 12, 18, and 24
|
|
OS Rate at 12, 24, 36, and 48 Months in FAS
기간: At Months 12, 24, 36, and 48
|
OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints.
OS was defined as the time from randomization to death from any cause.
K-M method was used to estimate OS rate.
Percentages have been rounded off.
|
At Months 12, 24, 36, and 48
|
|
TTDM, as Assessed by the Investigator in FAS
기간: Up to approximately 57 months
|
TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first.
Distant metastasis was defined as any new lesion that was outside of the radiation field.
K-M method was used to estimate median TTDM.
|
Up to approximately 57 months
|
|
Number of Participants With Adverse Events (AEs)
기간: Up to approximately 24.7 months
|
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product.
|
Up to approximately 24.7 months
|
|
Number of Participants With Cytokine Release Syndrome (CRS)
기간: Up to approximately 24.7 months
|
CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells.
Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction.
|
Up to approximately 24.7 months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Clinical Trials, Hoffmann-La Roche
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)
2020년 8월 24일
기본 완료 (실제)
2025년 5월 27일
연구 완료 (실제)
2025년 7월 31일
연구 등록 날짜
최초 제출
2020년 8월 13일
QC 기준을 충족하는 최초 제출
2020년 8월 13일
처음 게시됨 (실제)
2020년 8월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 7일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- GO41854
- 2019-004773-29 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
자격을 갖춘 연구원은 임상 연구 데이터 요청 플랫폼(www.vivli.org)을 통해 개별 환자 수준 데이터에 대한 액세스를 요청할 수 있습니다.
적격 연구에 대한 Roche의 기준에 대한 자세한 내용은 여기(https://vivli.org/members/ourmembers/)에서 확인할 수 있습니다. 임상 정보 공유에 관한 Roche의 글로벌 정책 및 관련 임상 연구 문서에 대한 액세스 요청 방법에 대한 자세한 내용은 여기(https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)를 참조하십시오.
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. .