Lung Cancer Clinical Trial

A Study of Atezolizumab in Participants With Programmed Death – Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary

This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult participants greater than or equal to 18 years of age
Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory
Measurable disease, as defined by RECIST version 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exception are allowed:

Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs) approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1

Central nervous system (CNS) disease, including treated brain metastases
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome
History of autoimmune disease
History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted
Active hepatitis B or hepatitis C
Human Immunodeficiency virus (HIV) positive
Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

667

Study ID:

NCT02031458

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 104 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center
Gilbert Arizona, 85234, United States
HonorHealth Research Institute - Bisgrove
Scottsdale Arizona, 85258, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Angeles Clinic & Rsch Inst
Los Angeles California, 90025, United States
City of Hope National Medical Group
South Pasadena California, 91030, United States
Stanford Cancer Center
Stanford California, 94305, United States
University of Colorado Health Science Center; Biomedical Research Bldg. Room 511
Aurora Colorado, 80045, United States
Yale Cancer Center; Medical Oncology
New Haven Connecticut, 06520, United States
Georgetown University Medical Center Lombardi Cancer Center
Washington District of Columbia, 20007, United States
Florida Cancer Specialists; SCRI
Fort Myers Florida, 33901, United States
Florida Hospital Cancer Inst
Orlando Florida, 32804, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie Florida, 34952, United States
Florida Cancer Specialists.
Saint Petersburg Florida, 33705, United States
Emory Uni - Winship Cancer Center; Hematology/Oncology
Atlanta Georgia, 30322, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Northwestern University; Robert H. Lurie Comp Can Ctr
Chicago Illinois, 60611, United States
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago Illinois, 60637, United States
Uni of Maryland; Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Med Ctr; Hem/Onc
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Monter Cancer Center
Lake Success New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Carolina BioOncology Institute, PLCC
Huntersville North Carolina, 28078, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
Ohio State University; B406 Starling-Loving Hall
Columbus Ohio, 43210, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Fox Chase Cancer Center; Hematology/Oncology
Philadelphia Pennsylvania, 19111, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute; University of Utah
Salt Lake City Utah, 84112, United States
University of Virginia; Office of Sponsored Programs
Charlottesville Virginia, 22902, United States
University of Washington Seattle Cancer Care Alliance
Seattle Washington, 98195, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
Royal North Shore Hospital; Oncology
St. Leonards New South Wales, 2065, Australia
Princess AleXandra Hospital; Department of Medical Oncology
Woolloongabba Queensland, 4102, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne Victoria, 3000, Australia
Sir Charles Gairdner Hospital; Medical Oncology
Nedlands Western Australia, 6009, Australia
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
GHdC Site Saint-Joseph
Charleroi , 6000, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
Sint Augustinus Wilrijk
Wilrijk , 2610, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka , 78000, Bosnia and Herzegovina
University Clinical Center Sarajevo;Clinic for Pulmonary disease
Sarajevo , 71000, Bosnia and Herzegovina
University Clinical Center Sarajevo;Institute of oncology
Sarajevo , 71000, Bosnia and Herzegovina
Complex Oncology Center (COC)-Plovidiv
Plovdiv , 4000, Bulgaria
Specialized Hospital for Active Treatment of Oncology
Sofia , 1756, Bulgaria
BCCA-Vancouver Cancer Centre
Vancouver British Columbia, V5Z 4, Canada
Lakeridge Health Oshawa; Oncology
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre; Oncology
Ottawa Ontario, K1H 8, Canada
Sunnybrook Odette Cancer Centre
Toronto Ontario, M4N 3, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto Ontario, M5G 2, Canada
Hopital Augustin Morvan; Oncologie Thoracique
Brest , 29609, France
Hopital Cote De Nacre; Pneumologie
Caen , 14000, France
CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee
Limoges , 87042, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon , 69373, France
Hopital Arnaud De Villeneuve; Maladies Respiratoires
Montpellier , 34295, France
Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale
Nantes , 44805, France
Nouvel Hopital Civil; Pneumologie
Strasbourg , 67091, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif , 94805, France
Research institute for Clinical Medicine
Tbilisi , 0112, Georgia
Cancer Research Centre
Tbilisi , 0159, Georgia
MediClab Georgia
Tbilisi , 0160, Georgia
Chemotherapy and Immunotherapy Clinic Medulla
Tbilisi , 0186, Georgia
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen , 45122, Germany
LungenClinic Großhansdorf GmbH
Großhansdorf , 22927, Germany
Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin
Nürnberg , 90419, Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Oldenburg , 26121, Germany
Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie
Villingen-Schwenningen , 78052, Germany
Queen Elizabeth Hospital; Clinical Oncology
Hong Kong , , Hong Kong
Queen Mary Hospital; Dept. of Clinical Oncology
Hong Kong , , Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc
Shatin , , Hong Kong
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola Emilia-Romagna, 47014, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano Lombardia, 20133, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano Piemonte, 10043, Italy
National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine
Fukuoka , 810-8, Japan
Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine
Kanagawa , 236-0, Japan
Yokohama Municipal Citizen'S Hospital; Respiratory Medicine
Kanagawa , 240-8, Japan
Kitasato University Hospital; Respiratory Medicine
Kanagawa , 252-0, Japan
Kyoto University Hospital, Respiratory Medicine
Kyoto , 606-8, Japan
Sendai Kousei Hospital; Pulmonary Medicine
Miyagi , 980-0, Japan
Osaka International Cancer Institute; Thoracic Oncology
Osaka , 541-8, Japan
Kansai Medical university Hospital; Thoracic Oncology
Osaka , 573-1, Japan
Osaka Habikino Medical Center
Osaka , 583-8, Japan
National Cancer Center Hospital; Thoracic Medical Oncology
Tokyo , 104-0, Japan
Toranomon Hospital; Respiratory Medicine
Tokyo , 105-8, Japan
Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology
Amsterdam , 1066 , Netherlands
Amphia Ziekenhuis; Afdeling Longziekten
Breda , 4818 , Netherlands
Academ Ziekenhuis Groningen; Medical Oncology
Groningen , 9713 , Netherlands
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore , 11922, Singapore
National Cancer Centre; Medical Oncology
Singapore , 16961, Singapore
Institute of Oncology Ljubljana
Ljubljana , 1000, Slovenia
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
ICO Badalona - Hospital Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Universitaetsspital Basel; Onkologie
Basel , 4031, Switzerland
CHUV; Departement d'Oncologie
Lausanne , 1011, Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen , 9007, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich , 8091, Switzerland
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara , 06100, Turkey
Ankara Ataturk Chest Diseases Training and Research Hospital
Ankara , 06500, Turkey
Ege University School of Medicine; Chest Diseases Department
Izmir , 35100, Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya , 44280, Turkey
Barts & London School of Med; Medical Oncology
London , EC1A , United Kingdom
Royal Marsden Hospital - London
London , SW3 6, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

667

Study ID:

NCT02031458

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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