CompletedPhase 2NCT02031458

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

StatusCompleted
PhasePhase 2
U.S. locations110
SponsorHoffmann-La Roche
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Hoffmann-La Roche
Interventions being studied
Drug: Atezolizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

View original record ↗