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NCT04513925

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

829

Start Date

2020-08-24

Completion Date

2025-07-31

Last Updated

2026-06-03

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Atezolizumab

Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.

DRUG

Tiragolumab

Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.

DRUG

Durvalumab

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.

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

Locations (189)

Stanford University

Palo Alto, California, United States

Banner MD Anderson Cancer Center

Greeley, Colorado, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Cancer Care Centers of Brevard

Palm Bay, Florida, United States

Woodlands Medical Specialists, P.A.

Pensacola, Florida, United States

Florida Cancer Specialist, North Region

St. Petersburg, Florida, United States

Northwest Georgia Oncology Centers PC - Marietta

Marietta, Georgia, United States

Illinois Cancer Care

Peoria, Illinois, United States

New England Cancer Specialists

Brunswick, Maine, United States

Southcoast Health System

Fairhaven, Massachusetts, United States

Minnesota Oncology Hematology

Minneapolis, Minnesota, United States

HCA Midwest Health

Kansas City, Missouri, United States

Cox Health Systems

Springfield, Missouri, United States

Optum Health Care

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Titan Health Partners LLC, d/b/a Astera Cancer Care

East Brunswick, New Jersey, United States

San Juan Oncology Associates

Farmington, New Mexico, United States

New York Oncology Hematology,P.C.-Albany

Albany, New York, United States

Mount Sinai Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Prisma Health ? Upstate

Greenville, South Carolina, United States

Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States

Sarah Cannon Research Institute / Tennessee Oncology

Nashville, Tennessee, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

CEMIC

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

Sanatorio Parque S.A.

Rosario, Argentina

Blacktown Hospital

Blacktown, New South Wales, Australia

Macarthur Cancer Therapy Centre

Campbelltown, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Monash Health Translational Precinct

Victoria, Victoria, Australia

Fiona Stanley Hospital

Bull Creek, Western Australia, Australia

Tiroler Landeskrankenanstalten Ges.M.B.H.

Innsbruck, Austria

Kepler Universitätskliniken GmbH - Med Campus III

Linz, Austria

Klinik Penzing

Vienna, Austria

GHdC Site Les Viviers

Charleroi, Belgium

AZ Maria Middelares

Ghent, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

BC Cancer ? Abbotsford

Abbotsford British Columbia, British Columbia, Canada

BC Cancer - Victoria

Victoria, British Columbia, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

William Osler Health System Brampton Civic Hospital

Brampton, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Beijing Cancer Center

Beijing, China

Beijing Chest Hospital

Beijing, China

Jilin Cancer Hospital

Changchun, China

Xiangya Hospital Central South University

Changsha, China

Sichuan Provincial Cancer Hospital

Chengdu, China

Chongqing Cancer Hospital

Chongqing, China

Fujian Medical University Union Hospital

Fujian, China

Fujian Provincial Cancer Hospital

Fuzhou, China

Cancer Center, Sun Yat-sen University of Medical Sciences

Guangzhou, China

Hangzhou Cancer Hospital

Hangzhou, China

Shandong Cancer Hospital

Jinan, China

Zhongda Hospital Affiliated to Southeast University

Nanjing, China

The affiliated hospital of Qingdao university

Qingdao, China

Shanghai Chest Hospital

Shanghai, China

Cancer Hospital of Shantou University Medical College

Shantou, China

Shanxi Provincial Cancer Hospital

Taiyuan, China

Tianjin Cancer Hospital

Tianjin, China

The 2nd School of Medicine, WMU

Wenzhou, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, China

Henan Cancer Hospital

Zhengzhou, China

CHU Angers

Angers, France

Centre Francois Baclesse

Caen, France

Hopital Nord AP-HM

Marseille, France

Clinique Clémentville

Montpellier, France

Hopital Robert Schuman

Vantoux, France

Institut Gustave Roussy

Villejuif, France

Klinikum Braunschweig

Braunschweig, Germany

Klinikum Koeln-Merheim

Cologne, Germany

Universitaetsmedizin Goettingen

Göttingen, Germany

Thoraxklinik Heidelberg gGmbH

Heidelberg, Germany

Klinikum Bogenhausen

München, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

General Hospital "G.Papanikolaou"

Asvestochóri, Greece

Sotiria Hospital

Athens, Greece

Agioi Anargyroi Cancer Hospital

Kifissia, Greece

Princess Margaret Hospital, Oncology

Hong Kong, Hong Kong

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Tuen Mun Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Pokfulam, Hong Kong

Pécsi Tudományegyetem

Pécs, Hungary

Szent Borbala Korhaz

Tatabánya, Hungary

Tudogyogyintezet Torokbalint

Törökbálint, Hungary

Soroka Medical Center

Beersheba, Israel

Rambam Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

And 89 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (189)