A Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Participants With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) (SKYSCRAPER-03)

February 27, 2024 updated by: Hoffmann-La Roche

A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation

The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.

Study Overview

Status

Active, not recruiting

Study Type

Interventional

Enrollment (Actual)

829

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Buenos Aires, Argentina, C1431FWN
        • Cemic; Oncologia Clinica
      • Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
        • Hospital Británico de Buenos Aires
      • Cordoba, Argentina, X5004FHP
        • Clinica Universitaria Reina Fabiola
      • Rosario, Argentina, S2000QGB
        • Sanatorio Parque S.A.
      • Victoria, Australia, 3168
        • Monash Health Translational Precinct; Clinical Trials Centre, Level 3
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital
      • Campbelltown, New South Wales, Australia, 2560
        • Macarthur Cancer Therapy Centre
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital; Cancer Care Centre
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Western Australia
      • Bull Creek, Western Australia, Australia, 6149
        • Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
      • Innsbruck, Austria, 6020
        • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
      • Linz, Austria, 4020
        • Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
      • Wien, Austria, 1140
        • Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
      • Charleroi, Belgium, 6000
        • GHdC Site Notre Dame
      • Gent, Belgium, 9000
        • AZ Maria Middelares
      • Hasselt, Belgium, 3500
        • Jessa Zkh (Campus Virga Jesse)
    • BA
      • Salvador, BA, Brazil, 41253-190
        • Hospital Sao Rafael - HSR
    • CE
      • Fortaleza, CE, Brazil, 60336-232
        • CRIO - Centro Regional Integrado de Oncologia
    • PR
      • Curitiba, PR, Brazil, 80810-050
        • Centro Integrado de Oncologia de Curitiba
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Hospital de Cancer de Barretos
      • Sao Jose do Rio Preto, SP, Brazil, 15090-000
        • Hospital de Base de Sao Jose do Rio Preto
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • British Columbia
      • Abbotsford, 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; c/o Oncology Clinical Trials
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System Brampton Civic Hospital
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital Research Institute
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North
      • Beijing, China, 101149
        • Beijing Chest Hospital; Oncology Department
      • Beijing City, China, 100142
        • Beijing Cancer Center; Renal Cancer And Melanoma Department.
      • Changchun, China, 132013
        • Jilin Cancer Hospital
      • Changsha City, China, 410008
        • Xiangya Hospital Central South University
      • Changzhou, China, 213000
        • Changzhou Cancer Hospital
      • Chengdu, China, 610041
        • Sichuan Provincial Cancer Hospital
      • Chongqing, China, 400030
        • Chongqing Cancer Hospital
      • Fuzhou City, China, 350001
        • Fujian Medical University Union Hospital
      • Fuzhou City, China, 350014
        • Fujian Provincial Cancer Hospital
      • Guangzhou City, China, 510060
        • Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
      • Hangzhou City, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University
      • Hangzhou City, China, 310002
        • Hangzhou Cancer Hospital
      • Jinan, China, 250117
        • Shandong Cancer Hospital
      • Nanjing, China, 210009
        • Zhongda Hospital Affiliated to Southeast University
      • Nanjing City, China, 210029
        • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
      • Qingdao City, China, 266042
        • The Affiliated Hospital of Qingdao University
      • Shanghai, China, 200000
        • Shanghai chest hospital
      • Shanghai, China, 200433
        • Shanghai Pulmonary 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 City, China, 325000
        • The 2nd School of Medicine, WMU
      • Wuhan, China, 430079
        • Hubei Cancer Hospital
      • Wuhan City, China, 430023
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • 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
      • Angers, France, 49933
        • CHU Angers
      • Caen, France, 14000
        • CENTRE FRANCOIS BACLESSE; Oncologie- Pneumologie
      • Marseille, France, 13015
        • Hopital Nord AP-HM
      • Montpellier, France, 34070
        • Clinique Clémentville
      • Vantoux, France, 57070
        • Hopital Robert Schuman; Pneumologie
      • Villejuif cedex, France, 94805
        • Institut Gustave Roussy; Pathologie Thoracique
      • Braunschweig, Germany, 38114
        • Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
      • Göttingen, Germany, 37075
        • Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie
      • Heidelberg, Germany, 69126
        • Thoraxklinik Heidelberg gGmbH
      • Köln, Germany, 51109
        • Klinikum Koeln-Merheim; Lungenklinik
      • München, Germany, 81925
        • Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
      • Asvestochori, Greece, 570 10
        • General Hospital "G.Papanikolaou"; Pulmonogy Clinic
      • Athens, Greece, 104 31
        • Sotiria Hospital
      • Heraklion, Greece, 711 10
        • Univ General Hosp Heraklion; Medical Oncology
      • Kifisia, Greece, 145 64
        • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital; Clinical Onc
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital, Oncology; Department of Oncology
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital; Clinical Oncology
      • Pokfulam, Hong Kong
        • Queen Mary Hospital
      • Pécs, Hungary, 7623
        • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
      • Szolnok, Hungary, 5000
        • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
      • Tatabánya, Hungary, 2800
        • Szent Borbala Korhaz
      • Torokbalint, Hungary, 2045
        • Tudogyogyintezet Torokbalint
      • Beer Sheva, Israel, 8410100
        • Soroka Medical Center; Oncology Dept
      • Haifa, Israel, 3109601
        • Rambam Medical Center; Oncology
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center; Oncology Dept
      • Petah Tikva, Israel, 4910000
        • Rabin Medical Center; Oncology Dept
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
      • Parma, Emilia-Romagna, Italy, 43126
        • Azienda Ospedaliero Universitaria di Parma
    • Lazio
      • Roma, Lazio, Italy, 00144
        • IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico; U.O.C. di Radioterapia Oncologica
    • Liguria
      • Genova, Liguria, Italy, 16132
        • IRCCS AOU San Martino - IST
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; U.O. Radioterapia
      • Milano, Lombardia, Italy
        • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
      • Pavia, Lombardia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
    • Toscana
      • Pisa, Toscana, Italy, 56124
        • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
    • Veneto
      • Vicenza, Veneto, Italy, 36100
        • Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center
      • Chiba, Japan, 277-8577
        • National Cancer Center East
      • Hyogo, 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, 980-0873
        • 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
      • Cheongju si, Korea, Republic of, 28644
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • Goyang-si, Korea, Republic of, 10408
        • National Cancer Center
      • Gyeonggi-do, Korea, Republic of, 16247
        • St. Vincent's Hospital
      • Gyeonggi-do, Korea, Republic of, 16499
        • Ajou University Medical Center
      • Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital
      • Seongnam-si, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 06591
        • Seoul St Mary's Hospital
      • Ulsan, Korea, Republic of, 44033
        • Ulsan University Hosiptal
      • Amersfoort, Netherlands, 3813 TZ
        • Meander Medisch Centrum
      • Breda, Netherlands, 4818 CK
        • Amphia ziekenhuis
      • Leidschendam, Netherlands, 2262 BA
        • Medisch Centrum Haaglanden, locatie Antoniushove
      • Sittard-Geleen, Netherlands, 6162 BG
        • Zuyderland Medisch Centrum - Sittard Geleen
      • Auckland, New Zealand, 1023
        • Auckland City Hospital, Cancer and Blood Research
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
      • Olsztyn, Poland, 10-228
        • Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii; ZAK?.I O.KLINICZNY RADIOTERAPII
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
      • Warszawa, Poland, 02-781
        • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
      • Wroc?aw, Poland, 53-413
        • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii
      • Coimbra, Portugal, 3000-075
        • IPO de Coimbra; Servico de Oncologia Medica
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz; Departamento de Oncologia Medica
      • Porto, Portugal, 4200-072
        • IPO do Porto; Servico de Oncologia Medica
      • Porto, Portugal, 4100-180
        • Hospital CUF Porto; Servico Pneumologia
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron; Oncology
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre; Servicio de Oncologia
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Oncologia
      • Malaga, Spain, 29011
        • Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
      • Sevilla, Spain, 41014
        • Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
    • Castellon
      • Castellon de La Plana, Castellon, Spain, 12002
        • Hospital Provincial de Castellon; Servicio de Oncologia
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07198
        • Hospital Son Llatzer; Servicio de Oncologia
    • LA Coruña
      • A Coruña, LA Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
      • Taichung, Taiwan, 40447
        • China Medical University Hospital; Pulmonary and Critical Care Medicine
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
      • Bangkok, Thailand, 10400
        • Rajavithi Hospital; Division of Medical Oncology
      • Bangkok, Thailand, 10300
        • Vajira Hospital
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center
      • Songkhla, Thailand, 90110
        • Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
      • Adana, Turkey, 01220
        • Adana Baskent University Medical Faculty; Oncology
      • Ankara, Turkey, 06100
        • Ankara University Medical Faculty; Medikal Onkoloji
      • Ankara, Turkey, 06100
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Ankara, Turkey, 06500
        • Gazi University Medical Faculty, Oncology Hospital
      • Bornova, ?zm?r, Turkey, 35100
        • Ege University Medical Faculty; Medical Oncology Department
      • Diyarbakir, Turkey, 21280
        • Dicle University Faculty of Medicine
      • Edirne, Turkey, 22030
        • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
      • Istanbul, Turkey, 34098
        • Istanbul University Cerrahpasa Faculty of Medicine
      • Istanbul, Turkey, 34214
        • Medipol University Medical Faculty; Oncology Department
      • Malatya, Turkey, 44280
        • Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's NHS Trust
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Huddersfield, United Kingdom, HD3 3EA
        • Calderdale & Huddersfield Nhs Trust; Oncology
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary; Oncology Department
      • Maidstone, United Kingdom, ME16 9QQ
        • Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
      • Manchester, United Kingdom, M20 4BX
        • Christie Foundation Trust
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center, Inc
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer and Blood Institute
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University
    • Colorado
      • Greeley, Colorado, United States, 85234
        • Banner MD Anderson Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 33901-8101
        • Florida Cancer Specialists; Department of Oncology
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists, P.A.
      • Rockledge, Florida, United States, 32955
        • Cancer Care Centers of Brevard
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialist, North Region
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers PC - Marietta
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care
    • Maine
      • Brunswick, Maine, United States, 04011
        • New England Cancer Specialists
    • Massachusetts
      • Fairhaven, Massachusetts, United States, 02719
        • Southcoast Health System
    • Minnesota
      • Saint Paul, Minnesota, United States, 55102
        • Minnesota Oncology Hematology
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • HCA Midwest Health
      • Springfield, Missouri, United States, 65807
        • Cox Health Systems
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89102
        • Optum Health Care
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Titan Health Partners LLC, d/b/a Astera Cancer Care
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology,P.C.-Albany
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Prisma Health ? Upstate
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology Chattanooga
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology; Sarah Cannon Research Institute
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
  • Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (cCRT)
  • At least two prior cycles of platinum-based chemotherapy administered concurrently with radiotherapy (RT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
  • The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
  • No progression during or following concurrent platinum-based CRT
  • A known PD-L1 result
  • Life expectancy >/= 12 weeks
  • Adequate hematologic and end-organ function
  • Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
  • Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
  • Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab

Exclusion Criteria:

  • Any history of prior NSCLC and/or any history of prior treatment for NSCLC (participants must be newly diagnosed with unresectable Stage III disease)
  • NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
  • Any evidence of Stage IV disease
  • Treatment with sequential CRT for locally advanced NSCLC
  • Participants with locally advanced NSCLC who have progressed during or after the definitive cCRT prior to randomization
  • Any Grade >2 unresolved toxicity from previous CRT
  • Grade >= 2 pneumonitis from prior CRT
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis
  • History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death
  • Prior allogeneic stem cell or solid organ transplantation
  • Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
  • Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
  • Treatment with systemic immunosuppressive medication
  • Women who are pregnant, or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atezolizumab + Tiragolumab
Participants will receive atezolizumab administered intravenously (IV) on Day 1 of each 28-day cycle followed by tiragolumab administered IV on Day 1 of each 28-day cycle for a maximum of 13 cycles.
Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.
Other Names:
  • Tecentriq; RO5541267
Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.
Other Names:
  • MTIG7192A; RO7092284
Active Comparator: Durvalumab
Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles.
Durvalumab will be administered based on weight at 10 mg/kg IV every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle, or will be administered at a fixed dose of 1500 mg IV every 4 weeks (Q4W) (for participants whose weight >/= 30 kg) on Day 1 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Independent Review Facility (IRF)-assessed Progression Free Survival (PFS) in the PD-L1-positive Analysis Set (PPAS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
IRF-assessed PFS in the Full Analysis Set (FAS)
Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 114 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) in the PPAS
Time Frame: From randomization to death from any cause (up to approximately 114 months)
From randomization to death from any cause (up to approximately 114 months)
Investigator-assessed PFS in the PPAS
Time Frame: Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
IRF-assessed Confirmed Objective Response Rate (ORR) in the PPAS
Time Frame: From randomization up to approximately 114 months
From randomization up to approximately 114 months
Investigator-assessed Confirmed ORR in the PPAS
Time Frame: From randomization up to approximately 114 months
From randomization up to approximately 114 months
IRF-assessed Duration of Response (DOR) in the PPAS
Time Frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Investigator-assessed DOR in the PPAS
Time Frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PPAS
Time Frame: Up to approximately 114 months
TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.
Up to approximately 114 months
OS in the FAS
Time Frame: From randomization to death from any cause (up to approximately 114 months)
From randomization to death from any cause (up to approximately 114 months)
Investigator-assessed PFS in the FAS
Time Frame: Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 114 months)
IRF-assessed Confirmed ORR in the FAS
Time Frame: From randomization up to approximately 114 months
From randomization up to approximately 114 months
Investigator-assessed Confirmed ORR in the FAS
Time Frame: From randomization up to approximately 114 months
From randomization up to approximately 114 months
IRF-assessed DOR in the FAS
Time Frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
Investigator-assessed DOR in the FAS
Time Frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 114 months)
TTCD Assessed Using EORTC QLQ-C30 Score in the FAS
Time Frame: Up to approximately 114 months
TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.
Up to approximately 114 months
IRF-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the PPAS
Time Frame: 12, 18 and 24 months
12, 18 and 24 months
IRF-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the FAS
Time Frame: 12, 18 and 24 months
12, 18 and 24 months
Investigator-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the PPAS
Time Frame: 12, 18 and 24 months
12, 18 and 24 months
Investigator-assessed PFS Rates at 12 Months, 18 Months and 24 Months in the FAS
Time Frame: 12, 18 and 24 months
12, 18 and 24 months
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months in the PPAS
Time Frame: 12, 24, 36 and 48 months
12, 24, 36 and 48 months
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months in the FAS
Time Frame: 12, 24, 36 and 48 months
12, 24, 36 and 48 months
Investigator-assessed Time to Death or Distant Metastasis (TTDM) in the PPAS
Time Frame: From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 114 months)
From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 114 months)
Investigator-assessed TTDM in the FAS
Time Frame: From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 114 months)
From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 114 months)
Percentage of Participants With Adverse Events
Time Frame: Up to approximately 114 months
Up to approximately 114 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2020

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

August 13, 2020

First Submitted That Met QC Criteria

August 13, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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