Исследование атезолизумаба и тираголумаба по сравнению с дурвалумабом у участников с местнораспространенным, нерезектабельным немелкоклеточным раком легкого III стадии (НМРЛ) (SKYSCRAPER-03)
7 мая 2026 г. обновлено: Hoffmann-La Roche
Открытое рандомизированное исследование фазы III атезолизумаба и тираголумаба по сравнению с дурвалумабом у пациентов с местнораспространенным, неоперабельным немелкоклеточным раком легкого III стадии, у которых не прогрессировало после одновременной химиолучевой терапии на основе препаратов платины.
Целью данного исследования является оценка эффективности и безопасности атезолизумаба в комбинации с тираголумабом по сравнению с дурвалумабом у участников с местно-распространенным, нерезектабельным немелкоклеточным раком легкого III стадии (НМРЛ), которые одновременно получали не менее двух циклов препаратов платины. на основе химиолучевой терапии (ХЛТ) и не имели рентгенологического прогрессирования заболевания.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
829
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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New South Wales
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Blacktown, New South Wales, Австралия, 2148
- Blacktown Hospital
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Campbelltown, New South Wales, Австралия, 2560
- Macarthur Cancer Therapy Centre
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Kogarah, New South Wales, Австралия, 2217
- St George Hospital
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South Australia
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Bedford Park, South Australia, Австралия, 5042
- Flinders Medical Centre
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Victoria
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Victoria, Victoria, Австралия, 3168
- Monash Health Translational Precinct
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Western Australia
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Bull Creek, Western Australia, Австралия, 6149
- Fiona Stanley Hospital
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Innsbruck, Австрия, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, Австрия, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, Австрия, 1140
- Klinik Penzing
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Buenos Aires, Аргентина, C1431FWO
- CEMIC
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Ciudad Autonoma Buenos Aires, Аргентина, C1284AEB
- Hospital Británico de Buenos Aires
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Córdoba, Аргентина, X5004FHP
- Clínica Universitaria Reina Fabiola
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Rosario, Аргентина, S2000QGB
- Sanatorio Parque S.A.
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Charleroi, Бельгия, 6000
- GHdC Site Les Viviers
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Ghent, Бельгия, 9000
- AZ Maria Middelares
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Hasselt, Бельгия, 3500
- Jessa Zkh (Campus Virga Jesse)
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Ceará
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Fortaleza, Ceará, Бразилия, 60336-550
- CRIO - Centro Regional Integrado de Oncologia
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Paraná
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Curitiba, Paraná, Бразилия, 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, Бразилия, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Бразилия, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Бразилия, 14784-400
- Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, Бразилия, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Бразилия, 01246-000
- Instituto do Câncer do Estado de São Paulo - ICESP
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Pécs, Венгрия, 7623
- Pecsi Tudomanyegyetem
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Tatabánya, Венгрия, 2800
- Szent Borbala Korhaz
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Törökbálint, Венгрия, 2045
- Tudogyogyintezet Torokbalint
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Braunschweig, Германия, 38114
- Klinikum Braunschweig
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Cologne, Германия, 51109
- Klinikum Koeln-Merheim
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Göttingen, Германия, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, Германия, 69126
- Thoraxklinik Heidelberg gGmbH
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München, Германия, 81925
- Klinikum Bogenhausen
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Regensburg, Германия, 93053
- Universitätsklinikum Regensburg
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Hong Kong, Гонконг
- Tuen Mun Hospital
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Hong Kong, Гонконг
- Pamela Youde Nethersole Eastern Hospital
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Hong Kong, Гонконг, DUMMY_VALUE
- Queen Elizabeth Hospital
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Hong Kong, Гонконг, DUMMY_VALUE
- Princess Margaret Hospital, Oncology
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Pokfulam, Гонконг, DUMMY_VALUE
- Queen Mary Hospital
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Asvestochóri, Греция, 570 10
- General Hospital "G.Papanikolaou"
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Athens, Греция, 11527
- Sotiria Hospital
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Kifissia, Греция, 145 64
- Agioi Anargyroi Cancer Hospital
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Beersheba, Израиль, 8410100
- Soroka Medical Center
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Haifa, Израиль, 3109601
- Rambam Medical Center
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Jerusalem, Израиль, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, Израиль, 4941492
- Rabin Medical Center
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A Coruña, Испания, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, Испания, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Испания, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Испания, 28046
- Hospital Universitario La Paz
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Madrid, Испания, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, Испания, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, Испания, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Испания, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Испания, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, Испания, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, Испания, 12002
- Hospital Provincial de Castellon
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Campania
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Naples, Campania, Италия, 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, Италия, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Parma, Emilia-Romagna, Италия, 43100
- Azienda Ospedaliero Universitaria di Parma
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Lazio
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Rome, Lazio, Италия, 00128
- Policlinico Universitario Campus Biomedico
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Rome, Lazio, Италия, 00144
- IRCCS Istituto Regina Elena (IFO)
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Liguria
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Genoa, Liguria, Италия, 16132
- IRCCS AOU San Martino - IST
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Lombardy
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Brescia, Lombardy, Италия, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
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Milan, Lombardy, Италия, DUMMY_VALUE
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Pavia, Lombardy, Италия, 27100
- Fondazione IRCCS Policlinico San Matteo
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Tuscany
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Pisa, Tuscany, Италия, 56124
- Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
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Veneto
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Vicenza, Veneto, Италия, 36100
- Azienda ULSS 8 Berica
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British Columbia
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Abbotsford British Columbia, British Columbia, Канада, V2S 0C2
- BC Cancer ? Abbotsford
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Victoria, British Columbia, Канада, V8R 6V5
- BC Cancer - Victoria
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Ontario
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Barrie, Ontario, Канада, L4M 6M2
- Royal Victoria Regional Health Centre
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Brampton, Ontario, Канада, L6R 3J7
- William Osler Health System Brampton Civic Hospital
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Ottawa, Ontario, Канада, K1H 8L6
- Ottawa Hospital Research Institute
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Beijing, Китай, 101149
- Beijing Chest Hospital
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Beijing, Китай, 100142
- Beijing Cancer Center
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Changchun, Китай, 132013
- Jilin cancer hospital
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Changsha, Китай, 410008
- Xiangya Hospital Central South University
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Chengdu, Китай, 610041
- Sichuan Provincial Cancer Hospital
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Chongqing, Китай, 400030
- Chongqing Cancer Hospital
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Fujian, Китай, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Китай, 350014
- Fujian Provincial Cancer Hospital
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Guangzhou, Китай, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, Китай, 310002
- Hangzhou Cancer Hospital
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Jinan, Китай, 250117
- Shandong Cancer Hospital
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Nanjing, Китай, 210009
- Zhongda Hospital Affiliated to Southeast University
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Qingdao, Китай, 266042
- The Affiliated Hospital of Qingdao University
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Shanghai, Китай, 200000
- Shanghai Chest Hospital
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Shantou, Китай, 515041
- Cancer Hospital of Shantou University Medical College
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Taiyuan, Китай, 030013
- Shanxi Provincial Cancer Hospital
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Tianjin, Китай, 300060
- Tianjin Cancer Hospital
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Wenzhou, Китай, 325000
- The 2nd School of Medicine, WMU
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Xiamen, Китай, 361003
- The First Affiliated Hospital of Xiamen University
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Xuzhou, Китай, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Zhengzhou, Китай, 450008
- Henan Cancer Hospital
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Amersfoort, Нидерланды, 3813 TZ
- Meander Medisch Centrum
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Breda, Нидерланды, 4819 EV
- Amphia Ziekenhuis
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Leidschendam, Нидерланды, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
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Sittard-Geleen, Нидерланды, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
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Auckland, Новая Зеландия, 1023
- Auckland City Hospital, Cancer and Blood Research
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Gda?sk, Польша, 80-214
- Uniwersyteckie Centrum Kliniczne
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Olsztyn, Польша, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
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Otwock, Польша, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Warsaw, Польша, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
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Wroc?aw, Польша, 53-413
- Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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Coimbra, Португалия, 3000-075
- IPO de Coimbra
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Lisbon, Португалия, 1500-650
- Hospital da Luz
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Porto, Португалия, 4100-180
- Hospital CUF Porto
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Porto, Португалия, 4200-072
- IPO do Porto
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Birmingham, Соединенное Королевство, B9 5SS
- Birmingham Heartlands Hospital
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Cambridge, Соединенное Королевство, CB2 0QQ
- Addenbrooke's NHS Trust
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Glasgow, Соединенное Королевство, G12 0YN
- Beatson West of Scotland Cancer Centre
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Huddersfield, Соединенное Королевство, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
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Leicester, Соединенное Королевство, LE1 5WW
- Leicester Royal Infirmary
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Maidstone, Соединенное Королевство, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
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Manchester, Соединенное Королевство, M20 4BX
- Christie Foundation Trust
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Sheffield, Соединенное Королевство, S10 2SJ
- Weston Park Hospital
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California
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Palo Alto, California, Соединенные Штаты, 94305
- Stanford University
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Colorado
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Greeley, Colorado, Соединенные Штаты, 80631
- Banner MD Anderson Cancer Center
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Florida
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Fort Myers, Florida, Соединенные Штаты, 33901-8101
- Florida Cancer Specialists
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Palm Bay, Florida, Соединенные Штаты, 32901
- Cancer Care Centers of Brevard
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Pensacola, Florida, Соединенные Штаты, 32503
- Woodlands Medical Specialists, P.A.
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St. Petersburg, Florida, Соединенные Штаты, 33705
- Florida Cancer Specialist, North Region
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Georgia
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Marietta, Georgia, Соединенные Штаты, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, Соединенные Штаты, 61615
- Illinois Cancer Care
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Maine
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Brunswick, Maine, Соединенные Штаты, 04011
- New England Cancer Specialists
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Massachusetts
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Fairhaven, Massachusetts, Соединенные Штаты, 02719
- Southcoast Health System
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Minnesota
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Minneapolis, Minnesota, Соединенные Штаты, 55404
- Minnesota Oncology Hematology
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Missouri
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Kansas City, Missouri, Соединенные Штаты, 64132
- HCA Midwest Health
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Springfield, Missouri, Соединенные Штаты, 65807
- Cox Health Systems
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Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89106
- Optum Health Care
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New Jersey
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East Brunswick, New Jersey, Соединенные Штаты, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
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New Mexico
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Farmington, New Mexico, Соединенные Штаты, 87401
- San Juan Oncology Associates
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New York
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Albany, New York, Соединенные Штаты, 12208
- New York Oncology Hematology,P.C.-Albany
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New York, New York, Соединенные Штаты, 10029
- Mount Sinai Medical Center
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The Bronx, New York, Соединенные Штаты, 10461
- Montefiore Medical Center
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South Carolina
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Greenville, South Carolina, Соединенные Штаты, 29615
- Prisma Health ? Upstate
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Tennessee
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Chattanooga, Tennessee, Соединенные Штаты, 37403
- Tennessee Oncology Chattanooga
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Nashville, Tennessee, Соединенные Штаты, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Virginia
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Fairfax, Virginia, Соединенные Штаты, 22031
- Virginia Cancer Specialists
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Norfolk, Virginia, Соединенные Штаты, 23502
- Virginia Oncology Associates
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Bangkok, Таиланд, 10400
- Rajavithi Hospital
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Bangkok, Таиланд, 10300
- Vajira Hospital
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Bangkok, Таиланд, 10400
- Ramathibodi Hospital;Medicine/Oncology
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Songkhla, Таиланд, 90110
- Songklanagarind Hospital
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Taichung, Тайвань, 40447
- China Medical University Hospital
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Taipei, Тайвань, 112
- Taipei Veterans General Hospital
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Adana, Турция (Туркие), 01220
- Adana Baskent University Medical Faculty
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Ankara, Турция (Туркие), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, Турция (Туркие), 06100
- Ankara University Medical Faculty
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Ankara, Турция (Туркие), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, Турция (Туркие), 35100
- Ege University Medical Faculty
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Diyarbakır, Турция (Туркие), 21280
- Dicle University Faculty of Medicine
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Edirne, Турция (Туркие), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Турция (Туркие), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Турция (Туркие), 34214
- Medipol University Medical Faculty
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Malatya, Турция (Туркие), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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Angers, Франция, 49933
- CHU Angers
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Caen, Франция, 14000
- Centre François Baclesse
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Marseille, Франция, 13015
- Hopital Nord AP-HM
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Montpellier, Франция, 34070
- Clinique Clementville
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Vantoux, Франция, 57070
- Hôpital Robert Schuman
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Villejuif, Франция, 94805
- Institut Gustave Roussy
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Cheongju-si, Южная Корея, 28644
- Chungbuk National University Hospital
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Daegu, Южная Корея, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, Южная Корея, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Южная Корея, 16247
- St. Vincent's Hospital
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Gyeonggi-do, Южная Корея, 10408
- National Cancer Center
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Gyeonggi-do, Южная Корея, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, Южная Корея, 50612
- Pusan National University Yangsan Hospital
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Incheon, Южная Корея, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Южная Корея, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Южная Корея, 03080
- Seoul National University Hospital
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Seoul, Южная Корея, 05505
- Asan Medical Center
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Seoul, Южная Корея, 06351
- Samsung Medical Center
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Seoul, Южная Корея, 08308
- Korea University Guro Hospital
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Seoul, Южная Корея, 06591
- Seoul St Mary's Hospital
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Ulsan, Южная Корея, 44033
- Ulsan University Hosiptal
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Aichi, Япония, 464-8681
- Aichi Cancer Center
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Chiba, Япония, 277-8577
- National Cancer Center East
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Hyōgo, Япония, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, Япония, 252-0375
- Kitasato University Hospital
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Kyoto, Япония, 606-8507
- Kyoto University Hospital
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Miyagi, Япония, 981-0914
- Sendai Kousei Hospital
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Niigata, Япония, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Япония, 589-8511
- Kindai University Hospital
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Saitama, Япония, 362-0806
- Saitama Cancer Center
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Shizuoka, Япония, 411-8777
- Shizuoka Cancer Center
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Tokyo, Япония, 104-0045
- National Cancer Center Hospital
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Tokyo, Япония, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, Япония, 641-8510
- Wakayama Medical University Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Описание
Критерии включения:
- Восточная кооперативная онкологическая группа (ECOG) Состояние эффективности 0 или 1
- Гистологически или цитологически подтвержденный НМРЛ с местнораспространенным, нерезектабельным НМРЛ III стадии с плоскоклеточным или неплоскоклеточным гистологическим строением
- Позитронно-эмиссионная томография-компьютерная томография (ПЭТ-КТ) всего тела, выполненная до и в течение 42 дней после первой дозы одновременной химиолучевой терапии (кХЛТ)
- Не менее двух предшествующих циклов химиотерапии на основе препаратов платины, проводимых одновременно с лучевой терапией (ЛТ), которые должны быть завершены в течение 1–42 дней до рандомизации в исследовании (один цикл cCRT определяется как 21 или 28 дней).
- Компонент лучевой терапии (ЛТ) в cCRT должен был иметь общую дозу облучения 60 (±10 процентов [%]) Грэй (Гр) (от 54 Гр до 66 Гр) при использовании ЛТ с модулированной интенсивностью (предпочтительно) или 3D- соответствующая техника
- Отсутствие прогрессирования во время или после одновременной СРТ на основе платины
- Известный результат PD-L1
- Ожидаемая продолжительность жизни >/= 12 недель
- Адекватная гематологическая функция и функция органов-мишеней
- Участники женского пола должны быть готовы избегать беременности в течение 90 дней после последней дозы тираголумаба и 5 месяцев после последней дозы атезолизумаба или в течение 3 месяцев после последней дозы дурвалумаба.
- Участники мужского пола должны воздерживаться или использовать презерватив в течение периода лечения и в течение 90 дней после последней дозы тираголумаба.
- Участники мужского пола не должны сдавать сперму в период лечения и в течение 90 дней после последней дозы тираголумаба.
Критерий исключения:
- Любая история предшествующего НМРЛ и / или любая история предшествующего лечения НМРЛ (у участников должен быть недавно диагностирован неоперабельный рак III стадии)
- Известно, что НМРЛ имеет мутацию в гене рецептора эпидермального фактора роста (EGFR) или слитом онкогене киназы анапластической лимфомы (ALK).
- Любые признаки болезни IV стадии
- Лечение с помощью последовательной СРТ при местнораспространенном НМРЛ
- Участники с местно-распространенным НМРЛ, прогрессировавшие во время или после окончательной cCRT до рандомизации
- Любая неразрешенная токсичность >2 степени после предыдущей СРТ
- Пневмонит >= 2 степени после предшествующей СРТ
- Активное или история аутоиммунного заболевания или иммунодефицита
- История идиопатического легочного фиброза, организующейся пневмонии, лекарственно-индуцированного пневмонита или идиопатического пневмонита или признаки активного пневмонита
- Злокачественное новообразование, отличное от НМРЛ, в анамнезе в течение 5 лет до скрининга, за исключением злокачественных новообразований с незначительным риском метастазирования или смерти.
- Предшествующая аллогенная трансплантация стволовых клеток или паренхиматозных органов
- Активная инфекция вируса Эпштейна-Барр (EBV) или известная или предполагаемая хроническая активная инфекция EBV при скрининге
- Лечение исследуемой терапией в течение 28 дней до начала исследуемого лечения
- Предшествующее лечение агонистами CD137 или терапия блокады иммунных контрольных точек, включая антицитотоксический белок 4, ассоциированный с Т-лимфоцитами, анти-Т-клеточный иммунорецептор с доменами Ig и ITIM (анти-TIGIT), анти-PD-1 и анти-PD-L1
- Любое предшествующее иммуноопосредованное нежелательное явление >/= 3 степени или любое неразрешенное иммуноопосредованное нежелательное явление > 1 степени при получении любого предшествующего иммунотерапевтического агента, кроме агентов, блокирующих иммунные контрольные точки.
- Лечение системными иммунодепрессантами
- Женщины, которые беременны или кормят грудью
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Атезолизумаб + Тираголумаб
Участники будут получать атезолизумаб, вводимый внутривенно (в/в) в 1-й день каждого 28-дневного цикла, а затем тираголумаб, вводимый в/в в 1-й день каждого 28-дневного цикла, максимум 13 циклов.
|
Атезолизумаб в дозе 1680 мг каждые 4 недели (Q4W) будет вводиться внутривенно в 1-й день каждого 28-дневного цикла.
Другие имена:
Тираголумаб в дозе 840 мг каждые 4 недели будет вводиться внутривенно в 1-й день каждого 28-дневного цикла.
Другие имена:
|
|
Активный компаратор: Дурвалумаб
Участники будут получать дурвалумаб внутривенно в течение каждого 28-дневного цикла в течение максимум 13 циклов.
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Дурвалумаб будет вводиться в зависимости от массы тела в дозе 10 мг/кг внутривенно каждые 2 недели (Q2W) в дни 1 и 15 каждого 28-дневного цикла или будет вводиться в фиксированной дозе 1500 мг внутривенно каждые 4 недели (Q4W) ( для участников, чей вес >/= 30 кг) в 1-й день каждого 28-дневного цикла.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Временное ограничение: 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.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
|
PFS, as Assessed by an IRF in FAS
Временное ограничение: 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.
|
From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Survival (OS) in PPAS
Временное ограничение: 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 PPAS
Временное ограничение: 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 Objective Response Rate (ORR), as Assessed by an IRF in PPAS
Временное ограничение: 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.
|
Up to approximately 57 months
|
|
Confirmed ORR, as Assessed by the Investigator in PPAS
Временное ограничение: 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.
|
Up to approximately 57 months
|
|
Duration of Response (DOR), as Assessed by an IRF in PPAS
Временное ограничение: 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 PPAS
Временное ограничение: 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)
|
|
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
Временное ограничение: 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.
|
Up to approximately 57 months
|
|
TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS
Временное ограничение: 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
Временное ограничение: 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 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
Временное ограничение: 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
|
|
TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS
Временное ограничение: 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
|
|
OS in FAS
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Директор по исследованиям: Clinical Trials, Hoffmann-La Roche
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
24 августа 2020 г.
Первичное завершение (Действительный)
27 мая 2025 г.
Завершение исследования (Действительный)
31 июля 2025 г.
Даты регистрации исследования
Первый отправленный
13 августа 2020 г.
Впервые представлено, что соответствует критериям контроля качества
13 августа 2020 г.
Первый опубликованный (Действительный)
14 августа 2020 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
3 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
7 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Новообразования по локализации
- Новообразования
- Заболевания дыхательных путей
- Легочные заболевания
- Новообразования дыхательных путей
- Грудные новообразования
- Новообразования легких
- Рак, Бронхогенный
- Бронхиальные новообразования
- Карцинома немелкоклеточного легкого
- Противоопухолевые агенты, иммунологические
- Ингибиторы иммунных контрольных точек
- Противоопухолевые агенты
- Молекулярные механизмы фармакологического действия
- Дурвалумаб
- Атезолизумаб
- Тираголумаб
Другие идентификационные номера исследования
- GO41854
- 2019-004773-29 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
Квалифицированные исследователи могут запросить доступ к данным на уровне отдельных пациентов через платформу запроса данных клинических исследований (www.vivli.org).
Дополнительные сведения о критериях «Рош» для приемлемых исследований доступны здесь (https://vivli.org/members/ourmembers/). Дополнительные сведения о Глобальной политике компании «Рош» в отношении обмена клинической информацией и о том, как запросить доступ к соответствующим документам клинических исследований, см. здесь (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Да
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .