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

Completed · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT02031458

Run by

Hoffmann-La Roche

People needed

667

Starts

2014-01-22

Expected to finish

2019-01-11

Last updated by the study team

2020-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• HonorHealth Research Institute - Bisgrove — Scottsdale, Arizona, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Angeles Clinic & Rsch Inst — Los Angeles, California, United States
• City of Hope National Medical Group — South Pasadena, California, United States
• Stanford Cancer Center — Stanford, California, United States
• University of Colorado Health Science Center; Biomedical Research Bldg. Room 511 — Aurora, Colorado, United States
• Yale Cancer Center; Medical Oncology — New Haven, Connecticut, United States
• Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists; SCRI — Fort Myers, Florida, United States
• Florida Hospital Cancer Inst — Orlando, Florida, United States
• Hematology Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
• Florida Cancer Specialists. — St. Petersburg, Florida, United States
• Emory Uni - Winship Cancer Center; Hematology/Oncology — Atlanta, Georgia, United States
• Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
• Northwestern University; Robert H. Lurie Comp Can Ctr — Chicago, Illinois, United States
• University Of Chicago Medical Center; Section Of Hematology/Oncology — Chicago, Illinois, United States
• Uni of Maryland; Greenebaum Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Med Ctr; Hem/Onc — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Monter Cancer Center — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.