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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
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
Winston Chen and Phyllis Huang Professor
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Kavitha Ramchandran
Clinical Professor, Medicine - Oncology
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