Vanderbilt-Ingram Cancer Center

Participants are being asked to take part in this research study because they have advanced or metastatic squamous cell non-small cell lung cancer (NSCLC). The purpose of this research to study an investigational drug called BMS-936558 (anti-PD-1 antibody) which is being developed by Bristol-Myers Squibb (also known as BMS). 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. BMS would like to find out what effect, good or bad, the study drug has on men and women with metastatic squamous non-small cell lung cancer that cannot be treated by surgery, if the study drug can have an effect on the body-s immune response to a tumor, how the body-s immune response may change over the course of study treatment, if the study drug will cause a tumor to change size and if the study drug can cause the immune system to respond to the drug itself.

Criteria
 Inclusion Criteria:

 • Men and Women ≥ 18 years of age

 • Subjects with histologically- or cytologically-documented squamous cell NSCLC who present with Stage IIIB/ Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or recurrent disease following radiation therapy or surgical resection

 • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

 • Disease progression or recurrence after both first-line platinum doublet chemotherapy and at least one United States-Food and Drug Administration (US FDA) or European Medicines Agency (EMA)-approved subsequent line of systemic therapy

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

 Exclusion Criteria:

 • Active Central nervous system (CNS) metastases. Subjects are eligible if metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)

 • Subjects with carcinomatous meningitis

 • Active known or suspected autoimmune disease or subjects with interstitial lung disease

 • Prior treatment on either arm of study CA209017 or CA184104

 • 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, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

 • Subjects with a condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of study drug