A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/7/2019 |
Start Date: | January 22, 2014 |
End Date: | January 11, 2019 |
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.
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.
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
We found this trial at
38
sites
Click here to add this to my saved trials
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
Click here to add this to my saved trials
1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
Click here to add this to my saved trials
Click here to add this to my saved trials
Aurora, Colorado 80045
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Click here to add this to my saved trials
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Click here to add this to my saved trials
Click here to add this to my saved trials
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
Click here to add this to my saved trials
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Monter Cancer Center The Monter Cancer Center is a unique facility dedicated to providing state-of-the-art...
Click here to add this to my saved trials
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
Click here to add this to my saved trials
340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
Marietta, Georgia 30060
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Click here to add this to my saved trials
Click here to add this to my saved trials
2000 Circle of Hope Dr
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials