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



Status:Completed
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:January 22, 2014
End Date:January 11, 2019

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A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

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.


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
We found this trial at
38
sites
340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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1365 Clifton Road
Atlanta, Georgia 30322
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Aurora, CO
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Baltimore, Maryland 21201
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330 Brookline Avenue
Boston, Massachusetts 02215
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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303 East Superior Street
Chicago, Illinois 60611
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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320 West 10th Avenue
Columbus, Ohio 43210
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3840 Broadway
Fort Myers, Florida 33901
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Gilbert, Arizona 85234
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, Texas 77030
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9801 Kincey Avenue
Huntersville, North Carolina 28078
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450 Lakeville Rd
Lake Success, New York 11040
(516) 734-8900
Monter Cancer Center The Monter Cancer Center is a unique facility dedicated to providing state-of-the-art...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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11818 Wilshire Boulevard
Los Angeles, California 90025
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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300 20th Avenue North
Nashville, Tennessee 37203
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333 Cedar Street
New Haven, Connecticut 06520
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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2501 North Orange Avenue
Orlando, Florida 32804
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333 Cottman Avenue
Philadelphia, Pennsylvania 19111
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Petersburg, Florida 33705
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
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Scottsdale, Arizona 85258
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Seattle, WA
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209 South Fair Oaks Avenue
South Pasadena, California 91030
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St. Leonards, New South Wales 2065
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Stanford, California 94305
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Washington, District of Columbia 20057
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