A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (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.
Checked against the public recordLast updated Jan 6, 2020 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Hoffmann-La Roche
- Interventions being studied
- Drug: Atezolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Banner MD Anderson Cancer CenterGilbert, Arizona
- HonorHealth Research Institute - BisgroveScottsdale, Arizona
- City of Hope Comprehensive Cancer CenterDuarte, California
- Angeles Clinic & Rsch InstLos Angeles, California
- City of Hope National Medical GroupSouth Pasadena, California
- Stanford Cancer CenterStanford, California
- University of Colorado Health Science Center; Biomedical Research Bldg. Room 511Aurora, Colorado
- Yale Cancer Center; Medical OncologyNew Haven, Connecticut
- Georgetown University Medical Center Lombardi Cancer CenterWashington D.C., District of Columbia
- Florida Cancer Specialists; SCRIFort Myers, Florida
- Florida Hospital Cancer InstOrlando, Florida
- Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 6, 2020. Always confirm current availability with the study team.