Lung Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

829

Study ID:

NCT04513925

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 193 Locations for this study

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Arizona Clinical Research Center, Inc
Tucson Arizona, 85715, United States
Genesis Cancer and Blood Institute
Hot Springs Arkansas, 71913, United States
Stanford University
Palo Alto California, 94305, United States
Banner MD Anderson Cancer Center
Greeley Colorado, 85234, United States
Florida Cancer Specialists; Department of Oncology
Fort Myers Florida, 33901, United States
Woodlands Medical Specialists, P.A.
Pensacola Florida, 32503, United States
Cancer Care Centers of Brevard
Rockledge Florida, 32955, United States
Florida Cancer Specialist, North Region
Saint Petersburg Florida, 33705, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
New England Cancer Specialists
Brunswick Maine, 04011, United States
Southcoast Health System
Fairhaven Massachusetts, 02719, United States
Minnesota Oncology Hematology
Saint Paul Minnesota, 55102, United States
HCA Midwest Health
Kansas City Missouri, 64132, United States
Cox Health Systems
Springfield Missouri, 65807, United States
Optum Health Care
Las Vegas Nevada, 89102, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
Titan Health Partners LLC, d/b/a Astera Cancer Care
East Brunswick New Jersey, 08816, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
New York Oncology Hematology,P.C.-Albany
Albany New York, 12208, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Prisma Health ? Upstate
Greenville South Carolina, 29615, United States
Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
Tennessee Oncology; Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Cemic; Oncologia Clinica
Buenos Aires , C1431, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires , C1284, Argentina
Clinica Universitaria Reina Fabiola
Cordoba , X5004, Argentina
Sanatorio Parque S.A.
Rosario , S2000, Argentina
Blacktown Hospital
Blacktown New South Wales, 2148, Australia
Macarthur Cancer Therapy Centre
Campbelltown New South Wales, 2560, Australia
St George Hospital; Cancer Care Centre
Kogarah New South Wales, 2217, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit
Bull Creek Western Australia, 6149, Australia
Monash Health Translational Precinct; Clinical Trials Centre, Level 3
Victoria , 3168, Australia
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck , 6020, Austria
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten
Linz , 4020, Austria
Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten
Wien , 1140, Austria
GHdC Site Notre Dame
Charleroi , 6000, Belgium
AZ Maria Middelares
Gent , 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt , 3500, Belgium
Hospital Sao Rafael - HSR
Salvador BA, 41253, Brazil
Crio - Centro Regional Integrado de Oncologia
Fortaleza CE, 60336, Brazil
Centro Integrado de Oncologia de Curitiba
Curitiba PR, 80810, Brazil
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijui RS, 98700, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Hospital de Base de Sao Jose do Rio Preto
Sao Jose do Rio Preto SP, 15090, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
BC Cancer ? Abbotsford
Abbotsford British Columbia, V2S 0, Canada
BC Cancer - Victoria
Victoria British Columbia, V8R 6, Canada
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
Barrie Ontario, L4M 6, Canada
William Osler Health System Brampton Civic Hospital
Brampton Ontario, L6R 3, Canada
Ottawa Hospital Research Institute
Ottawa Ontario, K1Y 4, Canada
Health Sciences North
Sudbury Ontario, P3E 5, Canada
Beijing Cancer Center; Renal Cancer And Melanoma Department.
Beijing City , 10014, China
Beijing Chest Hospital; Oncology Department
Beijing , 10114, China
Jilin Cancer Hospital
Changchun , 13201, China
Xiangya Hospital Central South University
Changsha City , 41000, China
Changzhou Cancer hospital
Changzhou , 21300, China
Sichuan Provincial Cancer Hospital
Chengdu , 61004, China
Chongqing Cancer Hospital
Chongqing , 40003, China
Fujian Medical University Union Hospital
Fuzhou City , 35000, China
Fujian Provincial Cancer Hospital
Fuzhou City , 35001, China
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
Guangzhou City , 51006, China
Hangzhou Cancer Hospital
Hangzhou City , 31000, China
Sir Run Run Shaw Hospital Zhejiang University
Hangzhou City , 31001, China
Shandong Cancer Hospital
Jinan , 25011, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing City , 21002, China
Zhongda Hospital Affiliated to Southeast University
Nanjing , 21000, China
The affiliated hospital of Qingdao university
Qingdao City , 26604, China
Shanghai Chest Hospital
Shanghai , 20000, China
Shanghai Pulmonary Hospital
Shanghai , 20043, China
Cancer Hospital of Shantou University Medical College
Shantou , 51504, China
Shanxi Provincial Cancer Hospital
Taiyuan , 03001, China
Tianjin Cancer Hospital
Tianjin , 30006, China
The 2nd School of Medicine, WMU
Wenzhou City , 32500, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City , 43002, China
Hubei Cancer Hospital
Wuhan , 43007, China
The First Affiliated Hospital of Xiamen University
Xiamen , 36100, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou , 22100, China
Henan Cancer Hospital
Zhengzhou , 45000, China
CHU Angers
Angers , 49933, France
CENTRE FRANCOIS BACLESSE; Oncologie- Pneumologie
Caen , 14000, France
Hopital Nord AP-HM
Marseille , 13015, France
Clinique Clémentville
Montpellier , 34070, France
Hopital Robert Schuman; Pneumologie
Vantoux , 57070, France
Institut Gustave Roussy; Pathologie Thoracique
Villejuif cedex , 94805, France
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
Braunschweig , 38114, Germany
Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie
Göttingen , 37075, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg , 69126, Germany
Klinikum Koeln-Merheim; Lungenklinik
Köln , 51109, Germany
Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie
München , 81925, Germany
Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
Regensburg , 93053, Germany
General Hospital "G.Papanikolaou"; Pulmonogy Clinic
Asvestochori , 570 1, Greece
Sotiria Hospital
Athens , 104 3, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion , 711 1, Greece
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
Kifisia , 145 6, Greece
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology
Hong Kong , , Hong Kong
Princess Margaret Hospital, Oncology; Department of Oncology
Hong Kong , , Hong Kong
Queen Elizabeth Hospital; Clinical Oncology
Hong Kong , , Hong Kong
Tuen Mun Hospital; Clinical Onc
Hong Kong , , Hong Kong
Queen Mary Hospital
Pokfulam , , Hong Kong
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
Pécs , 7623, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
Szolnok , 5000, Hungary
Szent Borbala Korhaz
Tatabánya , 2800, Hungary
Tudogyogyintezet Torokbalint
Torokbalint , 2045, Hungary
Soroka Medical Center; Oncology Dept
Beer Sheva , 84101, Israel
Rambam Medical Center; Oncology
Haifa , 31096, Israel
Shaare Zedek Medical Center; Oncology Dept
Jerusalem , 91031, Israel
Rabin Medical Center; Oncology Dept
Petah Tikva , 49100, Israel
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Azienda Ospedaliero Universitaria di Parma
Parma Emilia-Romagna, 43126, Italy
Policlinico Universitario Campus Biomedico; U.O.C. di Radioterapia Oncologica
Roma Lazio, 00128, Italy
IRCCS Istituto Regina Elena (IFO); Oncologia Medica B
Roma Lazio, 00144, Italy
IRCCS AOU San Martino - IST
Genova Liguria, 16132, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; U.O. Radioterapia
Brescia Lombardia, 25123, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milano Lombardia, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia Lombardia, 27100, Italy
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
Pisa Toscana, 56124, Italy
Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza
Vicenza Veneto, 36100, Italy
Aichi Cancer Center
Aichi , 464-8, Japan
National Cancer Center East
Chiba , 277-8, Japan
National Hospital Organization Himeji Medical Center
Hyogo , 670-8, Japan
Kitasato University Hospital
Kanagawa , 252-0, Japan
Kyoto University Hospital
Kyoto , 606-8, Japan
Sendai Kousei Hospital
Miyagi , 980-0, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Kindai University Hospital
Osaka , 589-8, Japan
Saitama Cancer Center
Saitama , 362-0, Japan
Shizuoka Cancer Center
Shizuoka , 411-8, Japan
National Cancer Center Hospital
Tokyo , 104-0, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Wakayama Medical University Hospital
Wakayama , 641-8, Japan
Chungbuk National University Hospital
Cheongju si , 28644, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
St. Vincent's Hospital
Gyeonggi-do , 16247, Korea, Republic of
Ajou University Medical Center
Gyeonggi-do , 16499, Korea, Republic of
Pusan National University Yangsan Hospital
Gyeongsangnam-do , 50612, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 463-7, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Seoul St Mary's Hospital
Seoul , 06591, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
Ulsan University Hosiptal
Ulsan , 44033, Korea, Republic of
Meander Medisch Centrum
Amersfoort , 3813 , Netherlands
Amphia Ziekenhuis
Breda , 4818 , Netherlands
Medisch Centrum Haaglanden, locatie Antoniushove
Leidschendam , 2262 , Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen , 6162 , Netherlands
Auckland City Hospital, Cancer and Blood Research
Auckland , 1023, New Zealand
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
Gdansk , 80-21, Poland
Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii; ZAK?.I O.KLINICZNY RADIOTERAPII
Olsztyn , 10-22, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
Otwock , 05-40, Poland
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
Warszawa , 02-78, Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii; Oddz. Onkologii Klin. i Chemioterapii
Wroc?aw , 53-41, Poland
IPO de Coimbra; Servico de Oncologia Medica
Coimbra , 3000-, Portugal
Hospital da Luz; Departamento de Oncologia Medica
Lisboa , 1500-, Portugal
Hospital CUF Porto; Servico Pneumologia
Porto , 4100-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona Barcelona, 08916, Spain
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon de La Plana Castellon, 12002, Spain
Hospital Son Llatzer; Servicio de Oncologia
Palma de Mallorca Islas Baleares, 07198, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña LA Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid , 28046, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
Malaga , 29011, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia
Sevilla , 41014, Spain
China Medical University Hospital; Pulmonary and Critical Care Medicine
Taichung , 40447, Taiwan
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
Taipei , 112, Taiwan
Vajira Hospital
Bangkok , 10300, Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok , 10400, Thailand
Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center
Bangkok , 10400, Thailand
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory
Songkhla , 90110, Thailand
Adana Baskent University Medical Faculty; Oncology
Adana , 01220, Turkey
Ankara University Medical Faculty; Medikal Onkoloji
Ankara , 06100, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara , 06100, Turkey
Gazi University Medical Faculty, Oncology Hospital
Ankara , 06500, Turkey
Ege University Medical Faculty; Medical Oncology Department
Bornova, ?zm?r , 35100, Turkey
Dicle University Faculty of Medicine
Diyarbakir , 21280, Turkey
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
Edirne , 22030, Turkey
Istanbul University Cerrahpasa Faculty of Medicine
Istanbul , 34098, Turkey
Medipol University Medical Faculty; Oncology Department
Istanbul , 34214, Turkey
Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,
Malatya , 44280, Turkey
Birmingham Heartlands Hospital
Birmingham , B9 5S, United Kingdom
Addenbrooke's NHS Trust
Cambridge , CB2 0, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Calderdale & Huddersfield Nhs Trust; Oncology
Huddersfield , HD3 3, United Kingdom
Leicester Royal Infirmary; Oncology Department
Leicester , LE1 5, United Kingdom
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center
Maidstone , ME16 , United Kingdom
Christie Foundation Trust
Manchester , M20 4, United Kingdom
Weston Park Hospital
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

829

Study ID:

NCT04513925

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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