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

  • Interventional
  • Not Recruiting
  • NCT02031458
Eligibility Details Visit Clinicaltrials.gov

A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With 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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT02031458

IRB#IRB13-1207

Lead SponsorHoffmann-La Roche

Lead PhysicianJyoti Patel

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting