Gene Therapy Clinical Trials

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: Atezolizumab

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting