Badanie atezolizumabu i tiragolumabu w porównaniu z durwalumabem u uczestników z miejscowo zaawansowanym, nieoperacyjnym niedrobnokomórkowym rakiem płuca (NSCLC) w stadium III (SKYSCRAPER-03)
7 maja 2026 zaktualizowane przez: Hoffmann-La Roche
Otwarte, randomizowane badanie fazy III dotyczące atezolizumabu i tiragolumabu w porównaniu z durwalumabem u pacjentów z miejscowo zaawansowanym, nieoperacyjnym niedrobnokomórkowym rakiem płuca w stadium III, u których nie wystąpiła progresja choroby po równoczesnej chemioradioterapii opartej na związkach platyny
Celem tego badania jest ocena skuteczności i bezpieczeństwa atezolizumabu w skojarzeniu z tyragolumabem w porównaniu z durwalumabem u uczestników z miejscowo zaawansowanym, nieoperacyjnym niedrobnokomórkowym rakiem płuca (NSCLC) w stadium III, którzy otrzymali co najmniej dwa cykle jednoczesnego opartej na chemioradioterapii (CRT) i nie stwierdzono u nich radiologicznej progresji choroby.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
829
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Buenos Aires, Argentyna, C1431FWO
- CEMIC
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Ciudad Autonoma Buenos Aires, Argentyna, C1284AEB
- Hospital Británico de Buenos Aires
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Córdoba, Argentyna, X5004FHP
- Clínica Universitaria Reina Fabiola
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Rosario, Argentyna, S2000QGB
- Sanatorio Parque S.A.
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Blacktown Hospital
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Campbelltown, New South Wales, Australia, 2560
- Macarthur Cancer Therapy Centre
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Kogarah, New South Wales, Australia, 2217
- St George Hospital
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Flinders Medical Centre
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Victoria
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Victoria, Victoria, Australia, 3168
- Monash Health Translational Precinct
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Western Australia
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Bull Creek, Western Australia, Australia, 6149
- Fiona Stanley Hospital
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Innsbruck, Austria, 6020
- Tiroler Landeskrankenanstalten Ges.M.B.H.
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Linz, Austria, 4020
- Kepler Universitätskliniken GmbH - Med Campus III
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Vienna, Austria, 1140
- Klinik Penzing
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Charleroi, Belgia, 6000
- GHdC Site Les Viviers
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Ghent, Belgia, 9000
- AZ Maria Middelares
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Hasselt, Belgia, 3500
- Jessa Zkh (Campus Virga Jesse)
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Ceará
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Fortaleza, Ceará, Brazylia, 60336-550
- CRIO - Centro Regional Integrado de Oncologia
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Paraná
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Curitiba, Paraná, Brazylia, 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, Brazylia, 98700-000
- Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
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Porto Alegre, Rio Grande do Sul, Brazylia, 90610-000
- Hospital Sao Lucas - PUCRS
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São Paulo
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Barretos, São Paulo, Brazylia, 14784-400
- Hospital de Cancer de Barretos
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São José do Rio Preto, São Paulo, Brazylia, 15090-000
- Hospital de Base de Sao Jose do Rio Preto
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São Paulo, São Paulo, Brazylia, 01246-000
- Instituto do Câncer do Estado de São Paulo - ICESP
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Beijing, Chiny, 101149
- Beijing Chest Hospital
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Beijing, Chiny, 100142
- Beijing Cancer Center
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Changchun, Chiny, 132013
- Jilin cancer hospital
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Changsha, Chiny, 410008
- Xiangya Hospital Central South University
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Chengdu, Chiny, 610041
- Sichuan Provincial Cancer Hospital
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Chongqing, Chiny, 400030
- Chongqing Cancer Hospital
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Fujian, Chiny, 350001
- Fujian Medical University Union Hospital
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Fuzhou, Chiny, 350014
- Fujian Provincial Cancer Hospital
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Guangzhou, Chiny, 510060
- Cancer Center, Sun Yat-sen University of Medical Sciences
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Hangzhou, Chiny, 310002
- Hangzhou Cancer Hospital
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Jinan, Chiny, 250117
- Shandong Cancer Hospital
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Nanjing, Chiny, 210009
- Zhongda Hospital Affiliated to Southeast University
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Qingdao, Chiny, 266042
- The Affiliated Hospital of Qingdao University
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Shanghai, Chiny, 200000
- Shanghai Chest Hospital
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Shantou, Chiny, 515041
- Cancer Hospital of Shantou University Medical College
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Taiyuan, Chiny, 030013
- Shanxi Provincial Cancer Hospital
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Tianjin, Chiny, 300060
- Tianjin Cancer Hospital
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Wenzhou, Chiny, 325000
- The 2nd School of Medicine, WMU
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Xiamen, Chiny, 361003
- The First Affiliated Hospital of Xiamen University
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Xuzhou, Chiny, 221000
- The Affiliated Hospital of Xuzhou Medical College
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Zhengzhou, Chiny, 450008
- Henan Cancer Hospital
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Angers, Francja, 49933
- CHU Angers
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Caen, Francja, 14000
- Centre François Baclesse
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Marseille, Francja, 13015
- Hopital Nord AP-HM
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Montpellier, Francja, 34070
- Clinique Clementville
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Vantoux, Francja, 57070
- Hôpital Robert Schuman
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Villejuif, Francja, 94805
- Institut Gustave Roussy
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Asvestochóri, Grecja, 570 10
- General Hospital "G.Papanikolaou"
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Athens, Grecja, 11527
- Sotiria Hospital
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Kifissia, Grecja, 145 64
- Agioi Anargyroi Cancer Hospital
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A Coruña, Hiszpania, 15006
- Complejo Hospitalario Universitario A Coruña (CHUAC)
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Barcelona, Hiszpania, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Hiszpania, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Hiszpania, 28046
- Hospital Universitario La Paz
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Madrid, Hiszpania, 28009
- Hospital General Universitario Gregorio Marañón
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Málaga, Hiszpania, 29010
- Hospital Regional Universitario Carlos Haya
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Seville, Hiszpania, 41013
- Hospital Universitario Virgen del Rocío
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Seville, Hiszpania, 41014
- Hospital Univ. Nuestra Señora de Valme
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Hiszpania, 07198
- Hospital Son Llatzer
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Barcelona
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Badalona, Barcelona, Hiszpania, 08916
- Hospital Universitari Germans Trias i Pujol
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Castellon
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Castellon, Castellon, Hiszpania, 12002
- Hospital Provincial de Castellon
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Amersfoort, Holandia, 3813 TZ
- Meander Medisch Centrum
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Breda, Holandia, 4819 EV
- Amphia Ziekenhuis
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Leidschendam, Holandia, 2262 BA
- Medisch Centrum Haaglanden, locatie Antoniushove
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Sittard-Geleen, Holandia, 6162 BG
- Zuyderland Medisch Centrum - Sittard Geleen
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Hong Kong, Hongkong
- Tuen Mun Hospital
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Hong Kong, Hongkong
- Pamela Youde Nethersole Eastern Hospital
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Hong Kong, Hongkong, DUMMY_VALUE
- Queen Elizabeth Hospital
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Hong Kong, Hongkong, DUMMY_VALUE
- Princess Margaret Hospital, Oncology
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Pokfulam, Hongkong, DUMMY_VALUE
- Queen Mary Hospital
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Beersheba, Izrael, 8410100
- Soroka Medical Center
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Haifa, Izrael, 3109601
- Rambam Medical Center
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Jerusalem, Izrael, 9103102
- Shaare Zedek Medical Center
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Petah Tikva, Izrael, 4941492
- Rabin Medical Center
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Aichi, Japonia, 464-8681
- Aichi Cancer Center
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Chiba, Japonia, 277-8577
- National Cancer Center East
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Hyōgo, Japonia, 670-8520
- National Hospital Organization Himeji Medical Center
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Kanagawa, Japonia, 252-0375
- Kitasato University Hospital
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Kyoto, Japonia, 606-8507
- Kyoto University Hospital
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Miyagi, Japonia, 981-0914
- Sendai Kousei Hospital
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Niigata, Japonia, 951-8566
- Niigata Cancer Center Hospital
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Osaka, Japonia, 589-8511
- Kindai University Hospital
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Saitama, Japonia, 362-0806
- Saitama Cancer Center
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Shizuoka, Japonia, 411-8777
- Shizuoka Cancer Center
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Tokyo, Japonia, 104-0045
- National Cancer Center Hospital
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Tokyo, Japonia, 135-8550
- The Cancer Institute Hospital of JFCR
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Wakayama, Japonia, 641-8510
- Wakayama Medical University Hospital
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British Columbia
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Abbotsford British Columbia, British Columbia, Kanada, V2S 0C2
- BC Cancer ? Abbotsford
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Victoria, British Columbia, Kanada, V8R 6V5
- BC Cancer - Victoria
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Ontario
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Barrie, Ontario, Kanada, L4M 6M2
- Royal Victoria Regional Health Centre
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Brampton, Ontario, Kanada, L6R 3J7
- William Osler Health System Brampton Civic Hospital
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Ottawa, Ontario, Kanada, K1H 8L6
- Ottawa Hospital Research Institute
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Cheongju-si, Korea Południowa, 28644
- Chungbuk National University Hospital
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Daegu, Korea Południowa, 41404
- Kyungpook National University Chilgok Hospital
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Gyeonggi-do, Korea Południowa, 13620
- Seoul National University Bundang Hospital
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Gyeonggi-do, Korea Południowa, 16247
- St. Vincent's Hospital
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Gyeonggi-do, Korea Południowa, 10408
- National Cancer Center
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Gyeonggi-do, Korea Południowa, 16499
- Ajou University Medical Center
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Gyeongsangnam-do, Korea Południowa, 50612
- Pusan National University Yangsan Hospital
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Incheon, Korea Południowa, 21565
- Gachon University Gil Medical Center
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Jeollanam-do, Korea Południowa, 58128
- Chonnam National University Hwasun Hospital
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Seoul, Korea Południowa, 03080
- Seoul National University Hospital
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Seoul, Korea Południowa, 05505
- Asan Medical Center
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Seoul, Korea Południowa, 06351
- Samsung Medical Center
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Seoul, Korea Południowa, 08308
- Korea University Guro Hospital
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Seoul, Korea Południowa, 06591
- Seoul St Mary's Hospital
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Ulsan, Korea Południowa, 44033
- Ulsan University Hosiptal
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Braunschweig, Niemcy, 38114
- Klinikum Braunschweig
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Cologne, Niemcy, 51109
- Klinikum Koeln-Merheim
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Göttingen, Niemcy, 37075
- Universitaetsmedizin Goettingen
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Heidelberg, Niemcy, 69126
- Thoraxklinik Heidelberg gGmbH
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München, Niemcy, 81925
- Klinikum Bogenhausen
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Regensburg, Niemcy, 93053
- Universitätsklinikum Regensburg
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Auckland, Nowa Zelandia, 1023
- Auckland City Hospital, Cancer and Blood Research
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Gda?sk, Polska, 80-214
- Uniwersyteckie Centrum Kliniczne
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Olsztyn, Polska, 10-228
- Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
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Otwock, Polska, 05-400
- Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
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Warsaw, Polska, 02-781
- Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
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Wroc?aw, Polska, 53-413
- Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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Coimbra, Portugalia, 3000-075
- IPO de Coimbra
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Lisbon, Portugalia, 1500-650
- Hospital da Luz
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Porto, Portugalia, 4100-180
- Hospital CUF Porto
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Porto, Portugalia, 4200-072
- IPO do Porto
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California
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Palo Alto, California, Stany Zjednoczone, 94305
- Stanford University
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Colorado
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Greeley, Colorado, Stany Zjednoczone, 80631
- Banner MD Anderson Cancer Center
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Florida
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Fort Myers, Florida, Stany Zjednoczone, 33901-8101
- Florida Cancer Specialists
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Palm Bay, Florida, Stany Zjednoczone, 32901
- Cancer Care Centers of Brevard
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Pensacola, Florida, Stany Zjednoczone, 32503
- Woodlands Medical Specialists, P.A.
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St. Petersburg, Florida, Stany Zjednoczone, 33705
- Florida Cancer Specialist, North Region
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Georgia
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Marietta, Georgia, Stany Zjednoczone, 30060
- Northwest Georgia Oncology Centers PC - Marietta
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Illinois
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Peoria, Illinois, Stany Zjednoczone, 61615
- Illinois Cancer Care
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Maine
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Brunswick, Maine, Stany Zjednoczone, 04011
- New England Cancer Specialists
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Massachusetts
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Fairhaven, Massachusetts, Stany Zjednoczone, 02719
- Southcoast Health System
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55404
- Minnesota Oncology Hematology
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Missouri
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Kansas City, Missouri, Stany Zjednoczone, 64132
- HCA Midwest Health
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Springfield, Missouri, Stany Zjednoczone, 65807
- Cox Health Systems
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89128
- Comprehensive Cancer Centers of Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89106
- Optum Health Care
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New Jersey
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East Brunswick, New Jersey, Stany Zjednoczone, 08816
- Titan Health Partners LLC, d/b/a Astera Cancer Care
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New Mexico
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Farmington, New Mexico, Stany Zjednoczone, 87401
- San Juan Oncology Associates
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New York
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Albany, New York, Stany Zjednoczone, 12208
- New York Oncology Hematology,P.C.-Albany
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New York, New York, Stany Zjednoczone, 10029
- Mount Sinai Medical Center
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The Bronx, New York, Stany Zjednoczone, 10461
- Montefiore Medical Center
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South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29615
- Prisma Health ? Upstate
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Tennessee
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Chattanooga, Tennessee, Stany Zjednoczone, 37403
- Tennessee Oncology Chattanooga
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Nashville, Tennessee, Stany Zjednoczone, 37203
- Sarah Cannon Research Institute / Tennessee Oncology
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Virginia
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Fairfax, Virginia, Stany Zjednoczone, 22031
- Virginia Cancer Specialists
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Norfolk, Virginia, Stany Zjednoczone, 23502
- Virginia Oncology Associates
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Bangkok, Tajlandia, 10400
- Rajavithi Hospital
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Bangkok, Tajlandia, 10300
- Vajira Hospital
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Bangkok, Tajlandia, 10400
- Ramathibodi Hospital;Medicine/Oncology
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Songkhla, Tajlandia, 90110
- Songklanagarind Hospital
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Taichung, Tajwan, 40447
- China Medical University Hospital
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Taipei, Tajwan, 112
- Taipei Veterans General Hospital
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Adana, Turcja (Türkiye), 01220
- Adana Baskent University Medical Faculty
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Ankara, Turcja (Türkiye), 06500
- Gazi University Medical Faculty, Oncology Hospital
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Ankara, Turcja (Türkiye), 06100
- Ankara University Medical Faculty
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Ankara, Turcja (Türkiye), 06100
- Hacettepe Universitesi Tip Fakultesi Hastanesi
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Bornova, ?zm?r, Turcja (Türkiye), 35100
- Ege University Medical Faculty
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Diyarbakır, Turcja (Türkiye), 21280
- Dicle University Faculty of Medicine
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Edirne, Turcja (Türkiye), 22030
- Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
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Istanbul, Turcja (Türkiye), 34098
- Istanbul University Cerrahpasa Faculty of Medicine
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Istanbul, Turcja (Türkiye), 34214
- Medipol University Medical Faculty
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Malatya, Turcja (Türkiye), 44280
- Inonu University Faculty of Medicine Turgut Ozal Medical Center
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Pécs, Węgry, 7623
- Pecsi Tudomanyegyetem
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Tatabánya, Węgry, 2800
- Szent Borbala Korhaz
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Törökbálint, Węgry, 2045
- Tudogyogyintezet Torokbalint
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Campania
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Naples, Campania, Włochy, 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, Włochy, 47014
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Parma, Emilia-Romagna, Włochy, 43100
- Azienda Ospedaliero Universitaria di Parma
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Lazio
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Rome, Lazio, Włochy, 00128
- Policlinico Universitario Campus Biomedico
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Rome, Lazio, Włochy, 00144
- IRCCS Istituto Regina Elena (IFO)
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Liguria
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Genoa, Liguria, Włochy, 16132
- IRCCS AOU San Martino - IST
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Lombardy
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Brescia, Lombardy, Włochy, 25123
- A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
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Milan, Lombardy, Włochy, DUMMY_VALUE
- Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
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Pavia, Lombardy, Włochy, 27100
- Fondazione IRCCS Policlinico San Matteo
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Tuscany
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Pisa, Tuscany, Włochy, 56124
- Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
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Veneto
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Vicenza, Veneto, Włochy, 36100
- Azienda ULSS 8 Berica
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Birmingham, Zjednoczone Królestwo, B9 5SS
- Birmingham Heartlands Hospital
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Cambridge, Zjednoczone Królestwo, CB2 0QQ
- Addenbrooke's NHS Trust
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Glasgow, Zjednoczone Królestwo, G12 0YN
- Beatson West of Scotland Cancer Centre
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Huddersfield, Zjednoczone Królestwo, HD3 3EA
- Calderdale & Huddersfield Nhs Trust
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Leicester, Zjednoczone Królestwo, LE1 5WW
- Leicester Royal Infirmary
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Maidstone, Zjednoczone Królestwo, ME16 9QQ
- Maidstone & Tonbridge Wells Hospital
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Manchester, Zjednoczone Królestwo, M20 4BX
- Christie Foundation Trust
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Sheffield, Zjednoczone Królestwo, S10 2SJ
- Weston Park Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Opis
Kryteria przyjęcia:
- Stan sprawności Eastern Cooperative Oncology Group (ECOG) 0 lub 1
- NSCLC udokumentowany histologicznie lub cytologicznie z miejscowo zaawansowanym, nieoperacyjnym NSCLC stopnia III o histologii płaskonabłonkowej lub niepłaskonabłonkowej
- Pozytonowa tomografia emisyjna całego ciała – tomografia komputerowa (PET-CT) całego ciała, wykonane przed i w ciągu 42 dni od pierwszej dawki równoczesnej chemioradioterapii (cCRT)
- Co najmniej dwa wcześniejsze cykle chemioterapii opartej na związkach platyny podawane jednocześnie z radioterapią (RT), które należy zakończyć w ciągu 1 do 42 dni przed randomizacją do badania (jeden cykl cCRT definiuje się jako 21 lub 28 dni)
- Komponent radioterapii (RT) w cCRT musiał być poddany całkowitej dawce promieniowania 60 (±10 procent [%]) szarości (Gy) (54 Gy do 66 Gy) podawanej przez RT o modulowanej intensywności (preferowane) lub 3D- technika konformistyczna
- Brak progresji podczas lub po równoczesnej CRT opartej na platynie
- Znany wynik PD-L1
- Oczekiwana długość życia >/= 12 tygodni
- Odpowiednia funkcja hematologiczna i narządów końcowych
- Kobiety biorące udział w badaniu muszą chcieć uniknąć ciąży przez 90 dni po przyjęciu ostatniej dawki tiragolumabu i 5 miesięcy po przyjęciu ostatniej dawki atezolizumabu lub przez 3 miesiące po przyjęciu ostatniej dawki durwalumabu
- Uczestnicy płci męskiej muszą zachować abstynencję lub używać prezerwatywy w okresie leczenia i przez 90 dni po przyjęciu ostatniej dawki tiragolumabu
- Uczestnikom płci męskiej nie wolno oddawać nasienia w okresie leczenia i przez 90 dni po przyjęciu ostatniej dawki tiragolumabu
Kryteria wyłączenia:
- Jakakolwiek historia wcześniejszego NSCLC i / lub jakakolwiek historia wcześniejszego leczenia NSCLC (uczestnicy muszą mieć nowo zdiagnozowaną nieresekcyjną chorobę w stadium III)
- NSCLC, o którym wiadomo, że ma mutację w genie receptora naskórkowego czynnika wzrostu (EGFR) lub onkogen fuzyjny kinazy chłoniaka anaplastycznego (ALK)
- Wszelkie dowody choroby w stadium IV
- Leczenie sekwencyjnej CRT miejscowo zaawansowanego NSCLC
- Uczestnicy z miejscowo zaawansowanym NSCLC, u których nastąpiła progresja w trakcie lub po ostatecznej cCRT przed randomizacją
- Dowolna nierozwiązana toksyczność stopnia >2 z poprzedniej CRT
- Zapalenie płuc stopnia >= 2. po wcześniejszej CRT
- Aktywna lub przebyta choroba autoimmunologiczna lub niedobór odporności
- Historia idiopatycznego włóknienia płuc, organizującego się zapalenia płuc, polekowego zapalenia płuc lub idiopatycznego zapalenia płuc lub dowodów na aktywne zapalenie płuc
- Historia nowotworu innego niż NSCLC w ciągu 5 lat przed skriningiem, z wyjątkiem nowotworów o znikomym ryzyku przerzutów lub zgonu
- Przebyty allogeniczny przeszczep komórek macierzystych lub narządu miąższowego
- Aktywna infekcja wirusem Epsteina-Barr (EBV) lub znana lub podejrzewana przewlekła aktywna infekcja EBV podczas badania przesiewowego
- Leczenie terapią eksperymentalną w ciągu 28 dni przed rozpoczęciem leczenia w ramach badania
- Wcześniejsze leczenie agonistami CD137 lub blokadami immunologicznych punktów kontrolnych, w tym przeciwcytotoksycznym białkiem 4 związanym z limfocytami T, immunoreceptorem limfocytów T z domenami Ig i ITIM (anty-TIGIT), anty-PD-1 i anty-PD-L1
- Jakiekolwiek wcześniejsze zdarzenie niepożądane o podłożu immunologicznym stopnia >/= 3 lub jakiekolwiek nierozwiązane zdarzenie niepożądane o podłożu immunologicznym stopnia > 1 podczas otrzymywania jakiegokolwiek wcześniejszego środka immunoterapeutycznego innego niż środki blokujące punkty kontrolne układu odpornościowego
- Leczenie ogólnoustrojowymi lekami immunosupresyjnymi
- Kobiety w ciąży lub karmiące piersią
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Atezolizumab + Tiragolumab
Uczestnicy otrzymają atezolizumab podany dożylnie (IV) w dniu 1 każdego 28-dniowego cyklu, a następnie tiragolumab podany dożylnie w dniu 1 każdego 28-dniowego cyklu przez maksymalnie 13 cykli.
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Atezolizumab 1680 mg co 4 tygodnie (Q4W) będzie podawany IV dnia 1 każdego 28-dniowego cyklu.
Inne nazwy:
Tiragolumab 840 mg Q4W będzie podawany dożylnie w 1. dniu każdego 28-dniowego cyklu.
Inne nazwy:
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Aktywny komparator: Durwalumab
Uczestnicy będą otrzymywać durwalumab podawany dożylnie podczas każdego 28-dniowego cyklu przez maksymalnie 13 cykli.
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Durwalumab będzie podawany na podstawie masy ciała w dawce 10 mg/kg dożylnie co 2 tygodnie (Q2W) w dniach 1. i 15 każdego 28-dniowego cyklu lub będzie podawany w stałej dawce 1500 mg IV co 4 tygodnie (Q4W) ( dla uczestników, których waga >/= 30 kg) w 1. dniu każdego 28-dniowego cyklu.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Ramy czasowe: 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
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall Survival (OS) in PPAS
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
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PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At Months 12, 24, 36, and 48
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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.
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At Months 12, 24, 36, and 48
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TTDM, as Assessed by the Investigator in FAS
Ramy czasowe: Up to approximately 57 months
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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.
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Up to approximately 57 months
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Number of Participants With Adverse Events (AEs)
Ramy czasowe: Up to approximately 24.7 months
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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.
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Up to approximately 24.7 months
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Number of Participants With Cytokine Release Syndrome (CRS)
Ramy czasowe: Up to approximately 24.7 months
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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.
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Up to approximately 24.7 months
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Clinical Trials, Hoffmann-La Roche
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
24 sierpnia 2020
Zakończenie podstawowe (Rzeczywisty)
27 maja 2025
Ukończenie studiów (Rzeczywisty)
31 lipca 2025
Daty rejestracji na studia
Pierwszy przesłany
13 sierpnia 2020
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 sierpnia 2020
Pierwszy wysłany (Rzeczywisty)
14 sierpnia 2020
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
3 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
7 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Nowotwory według lokalizacji
- Nowotwory
- Choroby Układu Oddechowego
- Choroby płuc
- Nowotwory Układu Oddechowego
- Nowotwory klatki piersiowej
- Nowotwory płuc
- Rak, Bronchogenny
- Nowotwory oskrzeli
- Rak, płuco niedrobnokomórkowe
- Środki przeciwnowotworowe, immunologiczne
- Inhibitory immunologicznego punktu kontrolnego
- Środki przeciwnowotworowe
- Molekularne mechanizmy działania farmakologicznego
- DurvaLumab
- Atezolizumab
- Tiragolumab
Inne numery identyfikacyjne badania
- GO41854
- 2019-004773-29 (Numer EudraCT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
Wykwalifikowani badacze mogą poprosić o dostęp do danych na poziomie poszczególnych pacjentów za pośrednictwem platformy wniosków o dane z badań klinicznych (www.vivli.org).
Więcej informacji na temat kryteriów Roche dotyczących kwalifikujących się badań można znaleźć tutaj (https://vivli.org/members/ourmembers/). Więcej informacji na temat Globalnej polityki firmy Roche dotyczącej udostępniania informacji klinicznych oraz sposobu uzyskiwania dostępu do powiązanych dokumentów dotyczących badań klinicznych można znaleźć tutaj (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .