Trial Search Results

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

The purpose of this study is to look at the effects, good or bad, of MPDL3280A on patients with non-small cell lung cancer (NSCLC). MPDL3280A an experimental drug and is an antibody (a protein produced by the body's immune system) that affects the immune system by blocking the programmed cell death-1 ligand 1 (PD-L1) pathway. The PD-L1 pathway is involved in regulating the body's natural immune response, but tumors can take advantage of this regulation to partially resist or evade the immune system. By blocking the PD L1 pathway, MPDL3280A may help the immune system stop or reverse the growth of tumors.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche


  • Drug: Atezolizumab


Phase 2


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting