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

NCT02031458

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Non-Small Cell Lung Cancer

Interventions: Atezolizumab

Countries: United States, Australia, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, France, Georgia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (110)

Gilbert, Arizona, United States
Scottsdale, Arizona, United States
Duarte, California, United States
Los Angeles, California, United States
South Pasadena, California, United States
Stanford, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
Orlando, Florida, United States
Port Saint Lucie, Florida, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Lake Success, New York, United States
New York, New York, United States
Huntersville, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Hershey, Pennsylvania, United States
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