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.
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
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There are 104 Locations for this study
Gilbert Arizona, 85234, United States
Scottsdale Arizona, 85258, United States
Duarte California, 91010, United States
Los Angeles California, 90025, United States
South Pasadena California, 91030, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06520, United States
Washington District of Columbia, 20007, United States
Fort Myers Florida, 33901, United States
Orlando Florida, 32804, United States
Port Saint Lucie Florida, 34952, United States
Saint Petersburg Florida, 33705, United States
Atlanta Georgia, 30322, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Saint Louis Missouri, 63110, United States
Lebanon New Hampshire, 03756, United States
Lake Success New York, 11042, United States
New York New York, 10065, United States
Huntersville North Carolina, 28078, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19111, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22902, United States
Seattle Washington, 98195, United States
Madison Wisconsin, 53792, United States
St. Leonards New South Wales, 2065, Australia
Woolloongabba Queensland, 4102, Australia
Heidelberg Victoria, 3084, Australia
Melbourne Victoria, 3000, Australia
Nedlands Western Australia, 6009, Australia
Bruxelles , 1200, Belgium
Charleroi , 6000, Belgium
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Banja Luka , 78000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Sarajevo , 71000, Bosnia and Herzegovina
Plovdiv , 4000, Bulgaria
Sofia , 1756, Bulgaria
Vancouver British Columbia, V5Z 4, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Brest , 29609, France
Caen , 14000, France
Limoges , 87042, France
Lyon , 69373, France
Montpellier , 34295, France
Nantes , 44805, France
Strasbourg , 67091, France
Villejuif , 94805, France
Tbilisi , 0112, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0186, Georgia
Essen , 45122, Germany
Großhansdorf , 22927, Germany
Nürnberg , 90419, Germany
Oldenburg , 26121, Germany
Villingen-Schwenningen , 78052, Germany
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Shatin , , Hong Kong
Meldola Emilia-Romagna, 47014, Italy
Milano Lombardia, 20133, Italy
Orbassano Piemonte, 10043, Italy
Fukuoka , 810-8, Japan
Kanagawa , 236-0, Japan
Kanagawa , 240-8, Japan
Kanagawa , 252-0, Japan
Kyoto , 606-8, Japan
Miyagi , 980-0, Japan
Osaka , 541-8, Japan
Osaka , 573-1, Japan
Osaka , 583-8, Japan
Tokyo , 104-0, Japan
Tokyo , 105-8, Japan
Amsterdam , 1066 , Netherlands
Breda , 4818 , Netherlands
Groningen , 9713 , Netherlands
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Ljubljana , 1000, Slovenia
Barcelona , 08035, Spain
Barcelona , 08916, Spain
Sevilla , 41013, Spain
Basel , 4031, Switzerland
Lausanne , 1011, Switzerland
St. Gallen , 9007, Switzerland
Zürich , 8091, Switzerland
Ankara , 06100, Turkey
Ankara , 06500, Turkey
Izmir , 35100, Turkey
Malatya , 44280, Turkey
London , EC1A , United Kingdom
London , SW3 6, United Kingdom
Sutton , SM2 5, United Kingdom
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