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CompletedPhase 2NCT02031458
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAtezolizumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 6, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?110 U.S. locations

Locations may change over time.

Who runs it?Hoffmann-La Roche

Study sponsor

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.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
PD-L1→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

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