A Phase III Study of MPDL3280A (Anti-PD-L1 Antibody) in Combination With Carboplatin + Paclitaxel With or Without Bevacizumab in Patients With Stage IV Non-squamous Non-small Cell Lung Cancer
Investigator: Brian L. Erickson, MD
Sponsor: Hoffmann-La Roche
Contact: Jennifer Montgomery, 541-706-6590 or firstname.lastname@example.org
Location: Bend, Oregon (Central Oregon)
Purpose: This randomized, open-label study will evaluate the safety and efficacy of Atezolizumab (MPDL3280A) in combination with carboplatin and paclitaxel with or without bevacizumab compared with treatment with carboplatin plus (+) paclitaxel and bevacizumab in chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer (NSCLC).
- 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed, treatment-naïve Stage IV non-squamous NSCLC
- Previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
- Measurable disease as defined by RECIST v1.1
- Adequate hematologic and end organ function
- Active or untreated central nervous system (CNS) metastases
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Pregnant or lactating women
- History of autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Positive test for Human Immunodeficiency Virus (HIV)
- Active hepatitis B or hepatitis C
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti PD1, and anti-PD-L1 therapeutic antibody
- Severe infection within 4 weeks prior to randomization
- Significant history of cardiovascular disease
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