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

Not Recruiting

Trial ID: NCT02031458

Purpose

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.

Official Title

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

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Millie Das
Millie Das

Clinical Professor, Medicine - Oncology

Eligibility


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

Intervention(s):

drug: Atezolizumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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