Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Studie atezolizumabu a tiragolumabu ve srovnání s durvalumabem u účastníků s lokálně pokročilým, neresekovatelným nemalobuněčným karcinomem plic stadia III (NSCLC) (SKYSCRAPER-03)

7. května 2026 aktualizováno: Hoffmann-La Roche

Otevřená, randomizovaná studie fáze III atezolizumabu a tiragolumabu ve srovnání s durvalumabem u pacientů s lokálně pokročilým, neresekabilním nemalobuněčným karcinomem plic stadia III, u kterých nedošlo k progresi po souběžné chemoradiaci na bázi platiny

Účelem této studie je zhodnotit účinnost a bezpečnost atezolizumabu v kombinaci s tiragolumabem ve srovnání s durvalumabem u účastníků s lokálně pokročilým, neresekabilním nemalobuněčným karcinomem plic stadia III (NSCLC), kteří dostávali alespoň dva cykly souběžné léčby platinou- chemoradioterapii (CRT) a neměli radiologickou progresi onemocnění.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

829

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Argentina
      • Buenos Aires, Argentina, C1431FWO
        • Cemic
      • Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
        • Hospital Britanico de Buenos Aires
      • Córdoba, Argentina, X5004FHP
        • Clinica Universitaria Reina Fabiola
      • Rosario, Argentina, S2000QGB
        • Sanatorio Parque S.A.
  • Austrálie
    • New South Wales
      • Blacktown, New South Wales, Austrálie, 2148
        • Blacktown Hospital
      • Campbelltown, New South Wales, Austrálie, 2560
        • Macarthur Cancer Therapy Centre
      • Kogarah, New South Wales, Austrálie, 2217
        • St George Hospital
    • South Australia
      • Bedford Park, South Australia, Austrálie, 5042
        • Flinders Medical Centre
    • Victoria
      • Victoria, Victoria, Austrálie, 3168
        • Monash Health Translational Precinct
    • Western Australia
      • Bull Creek, Western Australia, Austrálie, 6149
        • Fiona Stanley Hospital
  • Belgie
      • Charleroi, Belgie, 6000
        • GHdC Site Les Viviers
      • Ghent, Belgie, 9000
        • AZ Maria Middelares
      • Hasselt, Belgie, 3500
        • Jessa Zkh (Campus Virga Jesse)
  • Brazílie
    • Ceará
      • Fortaleza, Ceará, Brazílie, 60336-550
        • Crio - Centro Regional Integrado de Oncologia
    • Paraná
      • Curitiba, Paraná, Brazílie, 80810-050
        • Centro Integrado de Oncologia de Curitiba
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazílie, 98700-000
        • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
      • Porto Alegre, Rio Grande do Sul, Brazílie, 90610-000
        • Hospital Sao Lucas - PUCRS
    • São Paulo
      • Barretos, São Paulo, Brazílie, 14784-400
        • Hospital de Cancer de Barretos
      • São José do Rio Preto, São Paulo, Brazílie, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • São Paulo, São Paulo, Brazílie, 01246-000
        • Instituto do Câncer do Estado de São Paulo - ICESP
  • Francie
      • Angers, Francie, 49933
        • CHU Angers
      • Caen, Francie, 14000
        • Centre Francois Baclesse
      • Marseille, Francie, 13015
        • Hopital Nord AP-HM
      • Montpellier, Francie, 34070
        • Clinique Clémentville
      • Vantoux, Francie, 57070
        • Hopital Robert Schuman
      • Villejuif, Francie, 94805
        • Institut Gustave Roussy
  • Holandsko
      • Amersfoort, Holandsko, 3813 TZ
        • Meander Medisch Centrum
      • Breda, Holandsko, 4819 EV
        • Amphia Ziekenhuis
      • Leidschendam, Holandsko, 2262 BA
        • Medisch Centrum Haaglanden, locatie Antoniushove
      • Sittard-Geleen, Holandsko, 6162 BG
        • Zuyderland Medisch Centrum - Sittard Geleen
  • Hongkong
      • Hong Kong, Hongkong
        • Tuen Mun Hospital
      • Hong Kong, Hongkong
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, Hongkong, DUMMY_VALUE
        • Queen Elizabeth Hospital
      • Hong Kong, Hongkong, DUMMY_VALUE
        • Princess Margaret Hospital, Oncology
      • Pokfulam, Hongkong, DUMMY_VALUE
        • Queen Mary Hospital
  • Itálie
    • Campania
      • Naples, Campania, Itálie, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Itálie, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
      • Parma, Emilia-Romagna, Itálie, 43100
        • Azienda Ospedaliero Universitaria di Parma
    • Lazio
      • Rome, Lazio, Itálie, 00128
        • Policlinico Universitario Campus Biomedico
      • Rome, Lazio, Itálie, 00144
        • IRCCS Istituto Regina Elena (IFO)
    • Liguria
      • Genoa, Liguria, Itálie, 16132
        • IRCCS AOU San Martino - IST
    • Lombardy
      • Brescia, Lombardy, Itálie, 25123
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili
      • Milan, Lombardy, Itálie, DUMMY_VALUE
        • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
      • Pavia, Lombardy, Itálie, 27100
        • Fondazione IRCCS Policlinico San Matteo
    • Tuscany
      • Pisa, Tuscany, Itálie, 56124
        • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello
    • Veneto
      • Vicenza, Veneto, Itálie, 36100
        • Azienda ULSS 8 Berica
  • Izrael
      • Beersheba, Izrael, 8410100
        • Soroka Medical Center
      • Haifa, Izrael, 3109601
        • Rambam Medical Center
      • Jerusalem, Izrael, 9103102
        • Shaare Zedek Medical Center
      • Petah Tikva, Izrael, 4941492
        • Rabin Medical Center
  • Japonsko
      • Aichi, Japonsko, 464-8681
        • Aichi Cancer Center
      • Chiba, Japonsko, 277-8577
        • National Cancer Center East
      • Hyōgo, Japonsko, 670-8520
        • National Hospital Organization Himeji Medical Center
      • Kanagawa, Japonsko, 252-0375
        • Kitasato University Hospital
      • Kyoto, Japonsko, 606-8507
        • Kyoto University Hospital
      • Miyagi, Japonsko, 981-0914
        • Sendai Kousei Hospital
      • Niigata, Japonsko, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Japonsko, 589-8511
        • Kindai University Hospital
      • Saitama, Japonsko, 362-0806
        • Saitama Cancer Center
      • Shizuoka, Japonsko, 411-8777
        • Shizuoka Cancer Center
      • Tokyo, Japonsko, 104-0045
        • National Cancer Center Hospital
      • Tokyo, Japonsko, 135-8550
        • The Cancer Institute Hospital of JFCR
      • Wakayama, Japonsko, 641-8510
        • Wakayama Medical University Hospital
  • Jižní Korea
      • Cheongju-si, Jižní Korea, 28644
        • Chungbuk National University Hospital
      • Daegu, Jižní Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Gyeonggi-do, Jižní Korea, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Jižní Korea, 16247
        • St. Vincent's Hospital
      • Gyeonggi-do, Jižní Korea, 10408
        • National Cancer Center
      • Gyeonggi-do, Jižní Korea, 16499
        • Ajou University Medical Center
      • Gyeongsangnam-do, Jižní Korea, 50612
        • Pusan National University Yangsan Hospital
      • Incheon, Jižní Korea, 21565
        • Gachon University Gil Medical Center
      • Jeollanam-do, Jižní Korea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, Jižní Korea, 03080
        • Seoul National University Hospital
      • Seoul, Jižní Korea, 05505
        • Asan Medical Center
      • Seoul, Jižní Korea, 06351
        • Samsung Medical Center
      • Seoul, Jižní Korea, 08308
        • Korea University Guro Hospital
      • Seoul, Jižní Korea, 06591
        • Seoul St Mary's Hospital
      • Ulsan, Jižní Korea, 44033
        • Ulsan University Hosiptal
  • Kanada
    • British Columbia
      • Abbotsford British Columbia, British Columbia, Kanada, V2S 0C2
        • BC Cancer ? Abbotsford
      • Victoria, British Columbia, Kanada, V8R 6V5
        • BC Cancer - Victoria
    • Ontario
      • Barrie, Ontario, Kanada, L4M 6M2
        • Royal Victoria Regional Health Centre
      • Brampton, Ontario, Kanada, L6R 3J7
        • William Osler Health System Brampton Civic Hospital
      • Ottawa, Ontario, Kanada, K1H 8L6
        • Ottawa Hospital Research Institute
  • Maďarsko
      • Pécs, Maďarsko, 7623
        • Pécsi Tudományegyetem
      • Tatabánya, Maďarsko, 2800
        • Szent Borbala Korhaz
      • Törökbálint, Maďarsko, 2045
        • Tudogyogyintezet Torokbalint
  • Nový Zéland
      • Auckland, Nový Zéland, 1023
        • Auckland City Hospital, Cancer and Blood Research
  • Německo
      • Braunschweig, Německo, 38114
        • Klinikum Braunschweig
      • Cologne, Německo, 51109
        • Klinikum Koeln-Merheim
      • Göttingen, Německo, 37075
        • Universitaetsmedizin Goettingen
      • Heidelberg, Německo, 69126
        • Thoraxklinik Heidelberg gGmbH
      • München, Německo, 81925
        • Klinikum Bogenhausen
      • Regensburg, Německo, 93053
        • Universitätsklinikum Regensburg
  • Polsko
      • Gda?sk, Polsko, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Olsztyn, Polsko, 10-228
        • Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii
      • Otwock, Polsko, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
      • Warsaw, Polsko, 02-781
        • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
      • Wroc?aw, Polsko, 53-413
        • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
  • Portugalsko
      • Coimbra, Portugalsko, 3000-075
        • IPO de Coimbra
      • Lisbon, Portugalsko, 1500-650
        • Hospital da Luz
      • Porto, Portugalsko, 4100-180
        • Hospital CUF Porto
      • Porto, Portugalsko, 4200-072
        • IPO do Porto
  • Rakousko
      • Innsbruck, Rakousko, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.
      • Linz, Rakousko, 4020
        • Kepler Universitätskliniken GmbH - Med Campus III
      • Vienna, Rakousko, 1140
        • Klinik Penzing
  • Spojené království
      • Birmingham, Spojené království, B9 5SS
        • Birmingham Heartlands Hospital
      • Cambridge, Spojené království, CB2 0QQ
        • Addenbrooke's NHS Trust
      • Glasgow, Spojené království, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Huddersfield, Spojené království, HD3 3EA
        • Calderdale & Huddersfield Nhs Trust
      • Leicester, Spojené království, LE1 5WW
        • Leicester Royal Infirmary
      • Maidstone, Spojené království, ME16 9QQ
        • Maidstone & Tonbridge Wells Hospital
      • Manchester, Spojené království, M20 4BX
        • Christie Foundation Trust
      • Sheffield, Spojené království, S10 2SJ
        • Weston Park Hospital
  • Spojené státy
    • California
      • Palo Alto, California, Spojené státy, 94305
        • Stanford University
    • Colorado
      • Greeley, Colorado, Spojené státy, 80631
        • Banner MD Anderson Cancer Center
    • Florida
      • Fort Myers, Florida, Spojené státy, 33901-8101
        • Florida Cancer Specialists
      • Palm Bay, Florida, Spojené státy, 32901
        • Cancer Care Centers of Brevard
      • Pensacola, Florida, Spojené státy, 32503
        • Woodlands Medical Specialists, P.A.
      • St. Petersburg, Florida, Spojené státy, 33705
        • Florida Cancer Specialist, North Region
    • Georgia
      • Marietta, Georgia, Spojené státy, 30060
        • Northwest Georgia Oncology Centers PC - Marietta
    • Illinois
      • Peoria, Illinois, Spojené státy, 61615
        • Illinois Cancer Care
    • Maine
      • Brunswick, Maine, Spojené státy, 04011
        • New England Cancer Specialists
    • Massachusetts
      • Fairhaven, Massachusetts, Spojené státy, 02719
        • Southcoast Health System
    • Minnesota
      • Minneapolis, Minnesota, Spojené státy, 55404
        • Minnesota Oncology Hematology
    • Missouri
      • Kansas City, Missouri, Spojené státy, 64132
        • HCA Midwest Health
      • Springfield, Missouri, Spojené státy, 65807
        • Cox Health Systems
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Spojené státy, 89106
        • Optum Health Care
    • New Jersey
      • East Brunswick, New Jersey, Spojené státy, 08816
        • Titan Health Partners LLC, d/b/a Astera Cancer Care
    • New Mexico
      • Farmington, New Mexico, Spojené státy, 87401
        • San Juan Oncology Associates
    • New York
      • Albany, New York, Spojené státy, 12208
        • New York Oncology Hematology,P.C.-Albany
      • New York, New York, Spojené státy, 10029
        • Mount Sinai Medical Center
      • The Bronx, New York, Spojené státy, 10461
        • Montefiore Medical Center
    • South Carolina
      • Greenville, South Carolina, Spojené státy, 29615
        • Prisma Health ? Upstate
    • Tennessee
      • Chattanooga, Tennessee, Spojené státy, 37403
        • Tennessee Oncology Chattanooga
      • Nashville, Tennessee, Spojené státy, 37203
        • Sarah Cannon Research Institute / Tennessee Oncology
    • Virginia
      • Fairfax, Virginia, Spojené státy, 22031
        • Virginia Cancer Specialists
      • Norfolk, Virginia, Spojené státy, 23502
        • Virginia Oncology Associates
  • Tchaj-wan
      • Taichung, Tchaj-wan, 40447
        • China Medical University Hospital
      • Taipei, Tchaj-wan, 112
        • Taipei Veterans General Hospital
  • Thajsko
      • Bangkok, Thajsko, 10400
        • Rajavithi Hospital
      • Bangkok, Thajsko, 10300
        • Vajira Hospital
      • Bangkok, Thajsko, 10400
        • Ramathibodi Hospital;Medicine/Oncology
      • Songkhla, Thajsko, 90110
        • Songklanagarind Hospital
  • Turecko (Türkiye)
      • Adana, Turecko (Türkiye), 01220
        • Adana Baskent University Medical Faculty
      • Ankara, Turecko (Türkiye), 06500
        • Gazi University Medical Faculty, Oncology Hospital
      • Ankara, Turecko (Türkiye), 06100
        • Ankara University Medical Faculty
      • Ankara, Turecko (Türkiye), 06100
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Bornova, ?zm?r, Turecko (Türkiye), 35100
        • Ege University Medical Faculty
      • Diyarbakır, Turecko (Türkiye), 21280
        • Dicle University Faculty of Medicine
      • Edirne, Turecko (Türkiye), 22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Istanbul, Turecko (Türkiye), 34098
        • Istanbul University Cerrahpaşa Faculty of Medicine
      • Istanbul, Turecko (Türkiye), 34214
        • Medipol University Medical Faculty
      • Malatya, Turecko (Türkiye), 44280
        • Inonu University Faculty of Medicine Turgut Ozal Medical Center
  • Čína
      • Beijing, Čína, 101149
        • Beijing Chest Hospital
      • Beijing, Čína, 100142
        • Beijing Cancer Center
      • Changchun, Čína, 132013
        • Jilin Cancer Hospital
      • Changsha, Čína, 410008
        • Xiangya Hospital Central South University
      • Chengdu, Čína, 610041
        • Sichuan Provincial Cancer Hospital
      • Chongqing, Čína, 400030
        • Chongqing Cancer Hospital
      • Fujian, Čína, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, Čína, 350014
        • Fujian Provincial Cancer Hospital
      • Guangzhou, Čína, 510060
        • Cancer Center, Sun Yat-sen University of Medical Sciences
      • Hangzhou, Čína, 310002
        • Hangzhou Cancer Hospital
      • Jinan, Čína, 250117
        • Shandong Cancer Hospital
      • Nanjing, Čína, 210009
        • Zhongda Hospital Affiliated to Southeast University
      • Qingdao, Čína, 266042
        • The Affiliated Hospital of Qingdao University
      • Shanghai, Čína, 200000
        • Shanghai Chest Hospital
      • Shantou, Čína, 515041
        • Cancer Hospital of Shantou University Medical College
      • Taiyuan, Čína, 030013
        • Shanxi Provincial Cancer Hospital
      • Tianjin, Čína, 300060
        • Tianjin Cancer Hospital
      • Wenzhou, Čína, 325000
        • The 2nd School of Medicine, WMU
      • Xiamen, Čína, 361003
        • The First Affiliated Hospital of Xiamen University
      • Xuzhou, Čína, 221000
        • The Affiliated Hospital of Xuzhou Medical College
      • Zhengzhou, Čína, 450008
        • Henan Cancer Hospital
  • Řecko
      • Asvestochóri, Řecko, 570 10
        • General Hospital "G.Papanikolaou"
      • Athens, Řecko, 11527
        • Sotiria Hospital
      • Kifissia, Řecko, 145 64
        • Agioi Anargyroi Cancer Hospital
  • Španělsko
      • A Coruña, Španělsko, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC)
      • Barcelona, Španělsko, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Španělsko, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Španělsko, 28046
        • Hospital Universitario La Paz
      • Madrid, Španělsko, 28009
        • Hospital General Universitario Gregorio Marañón
      • Málaga, Španělsko, 29010
        • Hospital Regional Universitario Carlos Haya
      • Seville, Španělsko, 41013
        • Hospital Universitario Virgen del Rocio
      • Seville, Španělsko, 41014
        • Hospital Univ. Nuestra Señora de Valme
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Španělsko, 07198
        • Hospital Son Llatzer
    • Barcelona
      • Badalona, Barcelona, Španělsko, 08916
        • Hospital Universitari Germans Trias i Pujol
    • Castellon
      • Castellon, Castellon, Španělsko, 12002
        • Hospital Provincial de Castellon

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Stav výkonnosti Eastern Cooperative Oncology Group (ECOG) 0 nebo 1
  • Histologicky nebo cytologicky dokumentovaný NSCLC s lokálně pokročilým, neresekovatelným NSCLC stadia III, buď skvamózní nebo neskvamózní histologie
  • Celotělová pozitronová emisní tomografie-počítačová tomografie (PET-CT), provedená před a do 42 dnů od první dávky souběžné chemoradioterapie (cCRT)
  • Alespoň dva předchozí cykly chemoterapie na bázi platiny podávané současně s radioterapií (RT), které musí být dokončeny během 1 až 42 dnů před randomizací ve studii (jeden cyklus cCRT je definován jako 21 nebo 28 dnů)
  • Radioterapeutická (RT) složka v cCRT musela mít celkovou dávku záření 60 (±10 procent [%]) šedé (Gy) (54 Gy až 66 Gy) podávané RT s modulovanou intenzitou (preferováno) nebo 3D- vyhovující technika
  • Žádná progrese během nebo po souběžné CRT na bázi platiny
  • Známý výsledek PD-L1
  • Očekávaná délka života >/= 12 týdnů
  • Přiměřená hematologická funkce a funkce koncových orgánů
  • Účastnice musí být ochotny vyhnout se těhotenství po dobu 90 dnů po poslední dávce tiragolumabu a 5 měsíců po poslední dávce atezolizumabu nebo po dobu 3 měsíců po poslední dávce durvalumabu
  • Mužští účastníci musí během léčebného období a po dobu 90 dnů po poslední dávce tiragolumabu zůstat abstinovat nebo používat kondom.
  • Mužští účastníci nesmí darovat sperma během období léčby a 90 dnů po poslední dávce tiragolumabu

Kritéria vyloučení:

  • Jakákoli anamnéza předchozího NSCLC a/nebo jakákoli předchozí léčba NSCLC (účastníci musí být nově diagnostikováni s neresekovatelným onemocněním stadia III)
  • NSCLC, o kterém je známo, že má mutaci v genu receptoru epidermálního růstového faktoru (EGFR) nebo fúzního onkogenu kinázy anaplastického lymfomu (ALK)
  • Jakékoli známky onemocnění stadia IV
  • Léčba sekvenční CRT u lokálně pokročilého NSCLC
  • Účastníci s lokálně pokročilým NSCLC, kteří progredovali během nebo po definitivní cCRT před randomizací
  • Jakákoli nevyřešená toxicita stupně >2 z předchozí CRT
  • Pneumonitida stupně >= 2 z předchozí CRT
  • Aktivní nebo anamnéza autoimunitního onemocnění nebo imunitní nedostatečnosti
  • Anamnéza idiopatické plicní fibrózy, organizující se pneumonie, lékem indukovaná pneumonitida nebo idiopatická pneumonitida nebo známky aktivní pneumonitidy
  • Anamnéza jiné malignity než NSCLC během 5 let před screeningem s výjimkou malignit se zanedbatelným rizikem metastáz nebo úmrtí
  • Předchozí alogenní transplantace kmenových buněk nebo pevných orgánů
  • Aktivní infekce virem Epstein-Barrové (EBV) nebo známá nebo suspektní chronická aktivní infekce EBV při screeningu
  • Léčba hodnocenou terapií během 28 dnů před zahájením studijní léčby
  • Předchozí léčba agonisty CD137 nebo terapie blokády imunitního kontrolního bodu, včetně anticytotoxického proteinu 4 spojeného s T lymfocyty, imunoreceptoru proti T-buněk s doménami Ig a ITIM (anti-TIGIT), anti-PD-1 a anti-PD-L1
  • Jakákoli předchozí imunitně zprostředkovaná nežádoucí příhoda >/= 3. stupně nebo jakákoli nevyřešená imunitně zprostředkovaná nepříznivá příhoda > 1 stupně při užívání jakéhokoli předchozího imunoterapeutického činidla jiného než látek blokujících imunitní kontrolní bod
  • Léčba systémovými imunosupresivy
  • Ženy, které jsou těhotné nebo kojící

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Atezolizumab + tiragolumab
Účastníci dostanou atezolizumab podávaný intravenózně (IV) v den 1 každého 28denního cyklu a následně tiragolumab podávaný IV v den 1 každého 28denního cyklu po maximálně 13 cyklů.
Lék: Atezolizumab
Atezolizumab 1680 mg každé 4 týdny (Q4W) bude podáván IV v den 1 každého 28denního cyklu.
Ostatní jména:
  • Tecentriq; RO5541267
Lék: Tiragolumab
Tiragolumab 840 mg Q4W bude podáván IV v den 1 každého 28denního cyklu.
Ostatní jména:
  • MTIG7192A; RO7092284
Aktivní komparátor: Durvalumab
Účastníci dostanou durvalumab podávaný IV během každého 28denního cyklu po maximálně 13 cyklů.
Lék: Durvalumab
Durvalumab bude podáván na základě hmotnosti v dávce 10 mg/kg IV každé 2 týdny (Q2W) ve dnech 1 a 15 každého 28denního cyklu, nebo bude podáván ve fixní dávce 1500 mg IV každé 4 týdny (Q4W) ( pro účastníky s hmotností >/= 30 kg) v den 1 každého 28denního cyklu.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Časové okno: 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
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Overall Survival (OS) in PPAS
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Hoffmann-La Roche

Vyšetřovatelé

  • Ředitel studie: Clinical Trials, Hoffmann-La Roche

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

24. srpna 2020

Primární dokončení (Aktuální)

27. května 2025

Dokončení studie (Aktuální)

31. července 2025

Termíny zápisu do studia

První předloženo

13. srpna 2020

První předloženo, které splnilo kritéria kontroly kvality

13. srpna 2020

První zveřejněno (Aktuální)

14. srpna 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • GO41854
  • 2019-004773-29 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Kvalifikovaní výzkumní pracovníci mohou požádat o přístup k údajům na úrovni jednotlivých pacientů prostřednictvím platformy pro žádosti o údaje z klinických studií (www.vivli.org). Další podrobnosti o kritériích společnosti Roche pro způsobilé studie jsou k dispozici zde (https://vivli.org/members/ourmembers/). Další podrobnosti o globální politice společnosti Roche pro sdílení klinických informací a o tom, jak požádat o přístup k souvisejícím dokumentům klinických studií, naleznete zde (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Nemalobuněčný karcinom plic (NSCLC)

Klinické studie na Atezolizumab

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Jamaica

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit