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En undersøgelse af Atezolizumab og Tiragolumab sammenlignet med Durvalumab hos deltagere med lokalt avanceret, ikke-operabel fase III ikke-småcellet lungekræft (NSCLC) (SKYSCRAPER-03)

7. maj 2026 opdateret af: Hoffmann-La Roche

En fase III, open-label, randomiseret undersøgelse af Atezolizumab og Tiragolumab sammenlignet med Durvalumab hos patienter med lokalt avanceret, ikke-operabel fase III ikke-småcellet lungekræft, som ikke har udviklet sig efter samtidig platinbaseret kemoradiation

Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af ​​atezolizumab i kombination med tirvalumab sammenlignet med durvalumab hos deltagere med lokalt fremskreden, ikke-operabel fase III ikke-småcellet lungekræft (NSCLC), som har modtaget mindst to cyklusser af samtidig platin- baseret kemoradioterapi (CRT) og har ikke haft radiografisk sygdomsprogression.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

829

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0 eller 1
  • Histologisk eller cytologisk dokumenteret NSCLC med lokalt fremskreden, uoperabel trin III NSCLC af enten pladeepitel- eller ikke-pladeepitelhistologi
  • Helkrops positronemissionstomografi-computertomografi (PET-CT) scanning, udført før og inden for 42 dage efter den første dosis af samtidig kemoradioterapi (cCRT)
  • Mindst to tidligere cyklusser af platinbaseret kemoterapi administreret samtidig med strålebehandling (RT), som skal afsluttes inden for 1 til 42 dage før randomisering i undersøgelsen (én cyklus af cCRT er defineret som 21 eller 28 dage)
  • Strålebehandlingskomponenten (RT) i cCRT skal have været i en total strålingsdosis på 60 (±10 procent [%)) grå (Gy) (54 Gy til 66 Gy) administreret ved intensitetsmoduleret RT (foretrukket) eller 3D- konform teknik
  • Ingen progression under eller efter samtidig platinbaseret CRT
  • Et kendt PD-L1 resultat
  • Forventet levetid >/= 12 uger
  • Tilstrækkelig hæmatologisk funktion og endeorganfunktion
  • Kvindelige deltagere skal være villige til at undgå graviditet i 90 dage efter den sidste dosis af tirvalumab og 5 måneder efter den sidste dosis af atezolizumab eller i 3 måneder efter den sidste dosis af durvalumab
  • Mandlige deltagere skal forblive afholdende eller bruge kondom i behandlingsperioden og i 90 dage efter den sidste dosis tiragolumab
  • Mandlige deltagere må ikke donere sæd i behandlingsperioden og i 90 dage efter den sidste dosis tiragolumab

Ekskluderingskriterier:

  • Enhver historie med tidligere NSCLC og/eller tidligere behandling for NSCLC (deltagere skal være nydiagnosticeret med ikke-operable trin III-sygdom)
  • NSCLC kendt for at have en mutation i det epidermale vækstfaktor receptor (EGFR) genet eller et anaplastisk lymfom kinase (ALK) fusionsonkogen
  • Ethvert tegn på sygdom i fase IV
  • Behandling med sekventiel CRT for lokalt fremskreden NSCLC
  • Deltagere med lokalt fremskreden NSCLC, som har udviklet sig under eller efter den definitive cCRT før randomisering
  • Enhver grad >2 uafklaret toksicitet fra tidligere CRT
  • Grad >= 2 pneumonitis fra tidligere CRT
  • Aktiv eller historie med autoimmun sygdom eller immundefekt
  • Anamnese med idiopatisk lungefibrose, organiserende lungebetændelse, lægemiddelinduceret pneumonitis eller idiopatisk pneumonitis eller tegn på aktiv pneumonitis
  • Anamnese med anden malignitet end NSCLC inden for 5 år før screening med undtagelse af maligniteter med en ubetydelig risiko for metastaser eller død
  • Forudgående transplantation af allogene stamceller eller faste organer
  • Aktiv Epstein-Barr virus (EBV) infektion eller kendt eller formodet kronisk aktiv EBV infektion ved screening
  • Behandling med forsøgsbehandling inden for 28 dage før påbegyndelse af undersøgelsesbehandling
  • Tidligere behandling med CD137-agonister eller immuncheckpoint-blokadeterapier, inklusive anti-cytotoksisk T-lymfocyt-associeret protein 4, anti-T-celle-immunoreceptor med Ig- og ITIM-domæner (anti-TIGIT), anti-PD-1 og anti-PD-L1
  • Enhver tidligere grad >/= 3 immunmedieret uønsket hændelse eller enhver uafklaret grad > 1 immunmedieret bivirkning, mens du har modtaget et hvilket som helst tidligere immunterapimiddel, bortset fra immuncheckpoint-blokademidler
  • Behandling med systemisk immunsuppressiv medicin
  • Kvinder, der er gravide eller ammer

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Atezolizumab + Tiragolumab
Deltagerne vil modtage atezolizumab administreret intravenøst ​​(IV) på dag 1 i hver 28-dages cyklus efterfulgt af tiragolumab administreret IV på dag 1 i hver 28-dages cyklus i maksimalt 13 cyklusser.
Medicin: Atezolizumab
Atezolizumab 1680 mg hver 4. uge (Q4W) vil blive administreret IV på dag 1 i hver 28-dages cyklus.
Andre navne:
  • Tecentriq; RO5541267
Medicin: Tiragolumab
Tiragolumab 840 mg Q4W vil blive administreret IV på dag 1 i hver 28-dages cyklus.
Andre navne:
  • MTIG7192A; RO7092284
Aktiv komparator: Durvalumab
Deltagerne vil modtage durvalumab administreret IV under hver 28-dages cyklus i maksimalt 13 cyklusser.
Medicin: Durvalumab
Durvalumab vil blive administreret baseret på vægt ved 10 mg/kg IV hver 2. uge (Q2W) på dag 1 og 15 i hver 28-dages cyklus, eller vil blive administreret i en fast dosis på 1500 mg IV hver 4. uge (Q4W) ( for deltagere, hvis vægt >/= 30 kg) på dag 1 i hver 28-dages cyklus.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS)
Tidsramme: 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
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS) in PPAS
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. august 2020

Primær færdiggørelse (Faktiske)

27. maj 2025

Studieafslutning (Faktiske)

31. juli 2025

Datoer for studieregistrering

Først indsendt

13. august 2020

Først indsendt, der opfyldte QC-kriterier

13. august 2020

Først opslået (Faktiske)

14. august 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på individuelt patientniveau via platformen for anmodninger om kliniske undersøgelsesdata (www.vivli.org). Yderligere detaljer om Roches kriterier for kvalificerede undersøgelser er tilgængelige her (https://vivli.org/members/ourmembers/). For yderligere detaljer om Roches globale politik om deling af klinisk information og hvordan man anmoder om adgang til relaterede kliniske undersøgelsesdokumenter, se her (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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