SCCA Clinical Studies: Lung Cancer

The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.

• Men & women = 18 years of age
• Subjects with histologically or cytologically-documented locally advanced non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent disease following radiation therapy or surgical resection
• Disease recurrence or progression during/after one prior platinum-containing doublet chemotherapy regimen for advanced or metastatic disease
• Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status = 1
• A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle. Fine needle aspiration is insufficient

• Subjects with active Central nervous system (CNS) metastases are excluded. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of = 10mg daily Prednisone (or equivalent)
• Subjects with carcinomatous meningitis.
• Subjects with active, known or suspected autoimmune disease, or subjects with interstitial lung disease
• Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization
• Prior therapy with anti-programmed death-1 (anti-PD-1), anti programmed cell death ligand 1 (anti-PD-L1), anti programmed cell death ligand 2 (anti-PD-L2), anti-CD137, or anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
• Prior treatment with Docetaxel
• Treatment with any investigational agent within 28 days of first administration of study treatment