Vanderbilt-Ingram Cancer Center

Participants are being asked to take part in this research study because they have previously treated advanced or metastatic squamous cell Non-small Cell Lung Cancer (NSCLC). This study will test how safe and how well the investigational drug, BMS-936558, works in the body compared to another drug called Docetaxel. The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called BMS-936558. BMS-936558 is an antibody (a type of human protein) that is being tested to see if it will allow the body-s immune system to work against tumor cells. The effectiveness of BMS-936558 in lung cancer will be determined by comparing the observed change in tumor size and the survival of participants who receive the investigational drug BMS-936558 to those who receive docetaxel, an accepted standard of care therapy.

Criteria
 For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

 Inclusion Criteria:

 • Men & women ≥ 18 years of age

 • Subjects with histologically or cytologically-documented 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 chemotherapy regimen for advanced or metastatic disease

 • Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

 • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

 • An 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

 Exclusion Criteria:

 • 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 (PD-1), anti-Programmed cell death ligand 1 (PD-L1), anti-Programmed cell death ligand 2 (PD-L2), anti-CD137, or anti-Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

 • Prior treatment on the first line study CA184104 first line NSCLC study

 • Prior treatment with docetaxel

 • Treatment with any investigational agent within 28 days of first administration of study treatment