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Eine Studie zu Atezolizumab und Tiragolumab im Vergleich zu Durvalumab bei Teilnehmern mit lokal fortgeschrittenem, nicht resezierbarem nicht-kleinzelligem Lungenkrebs (NSCLC) im Stadium III (SKYSCRAPER-03)

7. Mai 2026 aktualisiert von: Hoffmann-La Roche

Eine offene, randomisierte Phase-III-Studie zu Atezolizumab und Tiragolumab im Vergleich zu Durvalumab bei Patienten mit lokal fortgeschrittenem, nicht resezierbarem nicht-kleinzelligem Lungenkrebs im Stadium III, die nach gleichzeitiger platinbasierter Radiochemotherapie keine Progression zeigten

Der Zweck dieser Studie ist die Bewertung der Wirksamkeit und Sicherheit von Atezolizumab in Kombination mit Tiragolumab im Vergleich zu Durvalumab bei Teilnehmern mit lokal fortgeschrittenem, inoperablem nicht-kleinzelligem Lungenkrebs (NSCLC) im Stadium III, die mindestens zwei Zyklen gleichzeitig Platin- basierte Chemoradiotherapie (CRT) und haben keine radiologische Krankheitsprogression gehabt.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

829

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Argentinien
      • Buenos Aires, Argentinien, C1431FWO
        • Cemic
      • Ciudad Autonoma Buenos Aires, Argentinien, C1284AEB
        • Hospital Britanico de Buenos Aires
      • Córdoba, Argentinien, X5004FHP
        • Clinica Universitaria Reina Fabiola
      • Rosario, Argentinien, 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 Cancer do Estado de Sao Paulo - ICESP
  • China
      • Beijing, China, 101149
        • Beijing Chest Hospital
      • Beijing, China, 100142
        • Beijing Cancer Center
      • Changchun, China, 132013
        • Jilin Cancer Hospital
      • Changsha, China, 410008
        • Xiangya Hospital Central South University
      • Chengdu, China, 610041
        • Sichuan Provincial Cancer Hospital
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou, China, 350014
        • Fujian Provincial Cancer Hospital
      • Guangzhou, China, 510060
        • Cancer Center, Sun Yat-sen University of Medical Sciences
      • Hangzhou, China, 310002
        • Hangzhou Cancer Hospital
      • Jinan, China, 250117
        • Shandong Cancer Hospital
      • Nanjing, China, 210009
        • Zhongda Hospital Affiliated to Southeast University
      • Qingdao, China, 266042
        • The Affiliated Hospital of Qingdao University
      • Shanghai, China, 200000
        • Shanghai Chest hospital
      • Shantou, China, 515041
        • Cancer Hospital of Shantou University Medical College
      • Taiyuan, China, 030013
        • Shanxi Provincial Cancer Hospital
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
      • Wenzhou, China, 325000
        • The 2nd School of Medicine, WMU
      • Xiamen, China, 361003
        • The First Affiliated Hospital of Xiamen University
      • Xuzhou, China, 221000
        • The Affiliated Hospital of Xuzhou Medical College
      • Zhengzhou, China, 450008
        • Henan Cancer Hospital
  • Deutschland
      • Braunschweig, Deutschland, 38114
        • Klinikum Braunschweig
      • Cologne, Deutschland, 51109
        • Klinikum Koeln-Merheim
      • Göttingen, Deutschland, 37075
        • Universitaetsmedizin Goettingen
      • Heidelberg, Deutschland, 69126
        • Thoraxklinik Heidelberg gGmbH
      • München, Deutschland, 81925
        • Klinikum Bogenhausen
      • Regensburg, Deutschland, 93053
        • Universitätsklinikum Regensburg
  • Frankreich
      • Angers, Frankreich, 49933
        • CHU Angers
      • Caen, Frankreich, 14000
        • Centre Francois Baclesse
      • Marseille, Frankreich, 13015
        • Hopital Nord AP-HM
      • Montpellier, Frankreich, 34070
        • Clinique Clémentville
      • Vantoux, Frankreich, 57070
        • Hopital Robert Schuman
      • Villejuif, Frankreich, 94805
        • Institut Gustave Roussy
  • Griechenland
      • Asvestochóri, Griechenland, 570 10
        • General Hospital "G.Papanikolaou"
      • Athens, Griechenland, 11527
        • Sotiria Hospital
      • Kifissia, Griechenland, 145 64
        • Agioi Anargyroi Cancer Hospital
  • 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
  • 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
  • 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
  • Neuseeland
      • Auckland, Neuseeland, 1023
        • Auckland City Hospital, Cancer and Blood Research
  • Niederlande
      • Amersfoort, Niederlande, 3813 TZ
        • Meander Medisch Centrum
      • Breda, Niederlande, 4819 EV
        • Amphia Ziekenhuis
      • Leidschendam, Niederlande, 2262 BA
        • Medisch Centrum Haaglanden, locatie Antoniushove
      • Sittard-Geleen, Niederlande, 6162 BG
        • Zuyderland Medisch Centrum - Sittard Geleen
  • 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 Marañon
      • 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
  • Südkorea
      • Cheongju-si, Südkorea, 28644
        • Chungbuk National University Hospital
      • Daegu, Südkorea, 41404
        • Kyungpook National University Chilgok Hospital
      • Gyeonggi-do, Südkorea, 13620
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Südkorea, 16247
        • St. Vincent's Hospital
      • Gyeonggi-do, Südkorea, 10408
        • National Cancer Center
      • Gyeonggi-do, Südkorea, 16499
        • Ajou University Medical Center
      • Gyeongsangnam-do, Südkorea, 50612
        • Pusan National University Yangsan Hospital
      • Incheon, Südkorea, 21565
        • Gachon University Gil Medical Center
      • Jeollanam-do, Südkorea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, Südkorea, 03080
        • Seoul National University Hospital
      • Seoul, Südkorea, 05505
        • Asan Medical Center
      • Seoul, Südkorea, 06351
        • Samsung Medical Center
      • Seoul, Südkorea, 08308
        • Korea University Guro Hospital
      • Seoul, Südkorea, 06591
        • Seoul St Mary's Hospital
      • Ulsan, Südkorea, 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
  • Türkei (türkiye)
      • Adana, Türkei (türkiye), 01220
        • Adana Baskent University Medical Faculty
      • Ankara, Türkei (türkiye), 06500
        • Gazi University Medical Faculty, Oncology Hospital
      • Ankara, Türkei (türkiye), 06100
        • Ankara University Medical Faculty
      • Ankara, Türkei (türkiye), 06100
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Bornova, ?zm?r, Türkei (türkiye), 35100
        • Ege University Medical Faculty
      • Diyarbakır, Türkei (türkiye), 21280
        • Dicle University Faculty of Medicine
      • Edirne, Türkei (türkiye), 22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Istanbul, Türkei (türkiye), 34098
        • Istanbul University Cerrahpasa Faculty of Medicine
      • Istanbul, Türkei (türkiye), 34214
        • Medipol University Medical Faculty
      • Malatya, Türkei (türkiye), 44280
        • Inonu University Faculty of Medicine Turgut Ozal Medical Center
  • Ungarn
      • Pécs, Ungarn, 7623
        • Pecsi Tudomanyegyetem
      • Tatabánya, Ungarn, 2800
        • Szent Borbala Korhaz
      • Törökbálint, Ungarn, 2045
        • Tudogyogyintezet Torokbalint
  • Vereinigte Staaten
    • California
      • Palo Alto, California, Vereinigte Staaten, 94305
        • Stanford University
    • Colorado
      • Greeley, Colorado, Vereinigte Staaten, 80631
        • Banner MD Anderson Cancer Center
    • Florida
      • Fort Myers, Florida, Vereinigte Staaten, 33901-8101
        • Florida Cancer Specialists
      • Palm Bay, Florida, Vereinigte Staaten, 32901
        • Cancer Care Centers of Brevard
      • Pensacola, Florida, Vereinigte Staaten, 32503
        • Woodlands Medical Specialists, P.A.
      • St. Petersburg, Florida, Vereinigte Staaten, 33705
        • Florida Cancer Specialist, North Region
    • Georgia
      • Marietta, Georgia, Vereinigte Staaten, 30060
        • Northwest Georgia Oncology Centers PC - Marietta
    • Illinois
      • Peoria, Illinois, Vereinigte Staaten, 61615
        • Illinois Cancer Care
    • Maine
      • Brunswick, Maine, Vereinigte Staaten, 04011
        • New England Cancer Specialists
    • Massachusetts
      • Fairhaven, Massachusetts, Vereinigte Staaten, 02719
        • Southcoast Health System
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55404
        • Minnesota Oncology Hematology
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 64132
        • HCA Midwest Health
      • Springfield, Missouri, Vereinigte Staaten, 65807
        • Cox Health Systems
    • Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Vereinigte Staaten, 89106
        • Optum Health Care
    • New Jersey
      • East Brunswick, New Jersey, Vereinigte Staaten, 08816
        • Titan Health Partners LLC, d/b/a Astera Cancer Care
    • New Mexico
      • Farmington, New Mexico, Vereinigte Staaten, 87401
        • San Juan Oncology Associates
    • New York
      • Albany, New York, Vereinigte Staaten, 12208
        • New York Oncology Hematology,P.C.-Albany
      • New York, New York, Vereinigte Staaten, 10029
        • Mount Sinai Medical Center
      • The Bronx, New York, Vereinigte Staaten, 10461
        • Montefiore Medical Center
    • South Carolina
      • Greenville, South Carolina, Vereinigte Staaten, 29615
        • Prisma Health ? Upstate
    • Tennessee
      • Chattanooga, Tennessee, Vereinigte Staaten, 37403
        • Tennessee Oncology Chattanooga
      • Nashville, Tennessee, Vereinigte Staaten, 37203
        • Sarah Cannon Research Institute / Tennessee Oncology
    • Virginia
      • Fairfax, Virginia, Vereinigte Staaten, 22031
        • Virginia Cancer Specialists
      • Norfolk, Virginia, Vereinigte Staaten, 23502
        • Virginia Oncology Associates
  • Vereinigtes Königreich
      • Birmingham, Vereinigtes Königreich, B9 5SS
        • Birmingham Heartlands Hospital
      • Cambridge, Vereinigtes Königreich, CB2 0QQ
        • Addenbrooke's NHS Trust
      • Glasgow, Vereinigtes Königreich, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Huddersfield, Vereinigtes Königreich, HD3 3EA
        • Calderdale & Huddersfield Nhs Trust
      • Leicester, Vereinigtes Königreich, LE1 5WW
        • Leicester Royal Infirmary
      • Maidstone, Vereinigtes Königreich, ME16 9QQ
        • Maidstone & Tonbridge Wells Hospital
      • Manchester, Vereinigtes Königreich, M20 4BX
        • Christie Foundation Trust
      • Sheffield, Vereinigtes Königreich, S10 2SJ
        • Weston Park Hospital
  • Österreich
      • Innsbruck, Österreich, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.
      • Linz, Österreich, 4020
        • Kepler Universitätskliniken GmbH - Med Campus III
      • Vienna, Österreich, 1140
        • Klinik Penzing

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Leistungsstatus der Eastern Cooperative Oncology Group (ECOG) von 0 oder 1
  • Histologisch oder zytologisch dokumentiertes NSCLC mit lokal fortgeschrittenem, inoperablem NSCLC im Stadium III mit entweder Plattenepithel- oder nicht Plattenepithel-Histologie
  • Ganzkörper-Positronen-Emissions-Tomographie-Computertomographie (PET-CT)-Scan, durchgeführt vor und innerhalb von 42 Tagen nach der ersten Dosis einer gleichzeitigen Radiochemotherapie (cCRT)
  • Mindestens zwei vorherige Zyklen einer platinbasierten Chemotherapie, die gleichzeitig mit einer Strahlentherapie (RT) verabreicht wurden, die innerhalb von 1 bis 42 Tagen vor der Randomisierung in der Studie abgeschlossen sein müssen (ein cCRT-Zyklus ist definiert als 21 oder 28 Tage)
  • Die Strahlentherapie (RT)-Komponente in der cCRT muss mit einer Gesamtstrahlendosis von 60 (±10 Prozent [%]) Gray (Gy) (54 Gy bis 66 Gy) behandelt worden sein, verabreicht durch intensitätsmodulierte RT (bevorzugt) oder 3D- konforme Technik
  • Keine Progression während oder nach gleichzeitiger platinbasierter CRT
  • Ein bekanntes PD-L1-Ergebnis
  • Lebenserwartung >/= 12 Wochen
  • Angemessene hämatologische und Endorganfunktion
  • Teilnehmerinnen müssen bereit sein, eine Schwangerschaft für 90 Tage nach der letzten Dosis von Tiragolumab und 5 Monate nach der letzten Dosis von Atezolizumab oder für 3 Monate nach der letzten Dosis von Durvalumab zu vermeiden
  • Männliche Teilnehmer müssen während des Behandlungszeitraums und für 90 Tage nach der letzten Tiragolumab-Dosis abstinent bleiben oder ein Kondom verwenden
  • Männliche Teilnehmer dürfen während des Behandlungszeitraums und 90 Tage nach der letzten Tiragolumab-Dosis kein Sperma spenden

Ausschlusskriterien:

  • Vorgeschichte von NSCLC und/oder Vorbehandlung von NSCLC (bei den Teilnehmern muss eine nicht resezierbare Erkrankung im Stadium III neu diagnostiziert werden)
  • NSCLC, von dem bekannt ist, dass es eine Mutation im epidermalen Wachstumsfaktorrezeptor (EGFR)-Gen oder in einem anaplastischen Lymphomkinase (ALK)-Fusionsonkogen aufweist
  • Irgendwelche Anzeichen einer Erkrankung im Stadium IV
  • Behandlung mit sequenzieller CRT bei lokal fortgeschrittenem NSCLC
  • Teilnehmer mit lokal fortgeschrittenem NSCLC, die während oder nach der endgültigen cCRT vor der Randomisierung Fortschritte gemacht haben
  • Jede ungelöste Toxizität >2 Grad von einer früheren CRT
  • Pneumonitis Grad >= 2 durch vorheriges CRT
  • Aktive oder Vorgeschichte einer Autoimmunerkrankung oder Immunschwäche
  • Geschichte der idiopathischen Lungenfibrose, organisierende Pneumonie, medikamenteninduzierte Pneumonitis oder idiopathische Pneumonitis oder Anzeichen einer aktiven Pneumonitis
  • Anamnese anderer Malignome als NSCLC innerhalb von 5 Jahren vor dem Screening mit Ausnahme von Malignomen mit einem vernachlässigbaren Metastasierungs- oder Todesrisiko
  • Vorherige allogene Stammzell- oder solide Organtransplantation
  • Aktive Infektion mit dem Epstein-Barr-Virus (EBV) oder bekannte oder vermutete chronische aktive EBV-Infektion beim Screening
  • Behandlung mit Prüftherapie innerhalb von 28 Tagen vor Beginn der Studienbehandlung
  • Vorherige Behandlung mit CD137-Agonisten oder Immun-Checkpoint-Blockadetherapien, einschließlich antizytotoxischem T-Lymphozyten-assoziiertem Protein 4, Anti-T-Zell-Immunrezeptor mit Ig- und ITIM-Domänen (Anti-TIGIT), Anti-PD-1 und Anti-PD-L1
  • Jedes frühere immunvermittelte unerwünschte Ereignis Grad >/= 3 oder jedes ungelöste immunvermittelte unerwünschte Ereignis Grad > 1 während der vorherigen Behandlung mit einem anderen Immuntherapeutikum als Immun-Checkpoint-Blockademitteln
  • Behandlung mit systemischen immunsuppressiven Medikamenten
  • Frauen, die schwanger sind oder stillen

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Atezolizumab + Tiragolumab
Die Teilnehmer erhalten an Tag 1 jedes 28-Tage-Zyklus Atezolizumab intravenös (IV) verabreicht, gefolgt von Tiragolumab, das an Tag 1 jedes 28-Tage-Zyklus für maximal 13 Zyklen intravenös verabreicht wird.
Arzneimittel: Atezolizumab
Atezolizumab 1680 mg alle 4 Wochen (Q4W) wird an Tag 1 jedes 28-tägigen Zyklus intravenös verabreicht.
Andere Namen:
  • Tecentriq; RO5541267
Arzneimittel: Tiragolumab
Tiragolumab 840 mg Q4W wird IV an Tag 1 jedes 28-tägigen Zyklus verabreicht.
Andere Namen:
  • MTIG7192A; RO7092284
Aktiver Komparator: Durvalumab
Die Teilnehmer erhalten Durvalumab intravenös während jedes 28-tägigen Zyklus für maximal 13 Zyklen verabreicht.
Arzneimittel: Durvalumab
Durvalumab wird basierend auf dem Gewicht mit 10 mg/kg i.v. alle 2 Wochen (Q2W) an den Tagen 1 und 15 jedes 28-Tage-Zyklus oder mit einer festen Dosis von 1500 mg i.v. alle 4 Wochen (Q4W) verabreicht ( für Teilnehmer mit einem Gewicht >/= 30 kg) an Tag 1 jedes 28-Tage-Zyklus.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Overall Survival (OS) in PPAS
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Ermittler

  • Studienleiter: Clinical Trials, Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. August 2020

Primärer Abschluss (Tatsächlich)

27. Mai 2025

Studienabschluss (Tatsächlich)

31. Juli 2025

Studienanmeldedaten

Zuerst eingereicht

13. August 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. August 2020

Zuerst gepostet (Tatsächlich)

14. August 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Qualifizierte Forscher können über die Datenanforderungsplattform für klinische Studien (www.vivli.org) Zugang zu individuellen Patientendaten beantragen. Weitere Einzelheiten zu den Kriterien von Roche für förderfähige Studien finden Sie hier (https://vivli.org/members/ourmembers/). Weitere Einzelheiten zu Roches Global Policy on the Sharing of Clinical Information und zur Beantragung des Zugriffs auf zugehörige klinische Studiendokumente finden Sie hier (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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