A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

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 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
with recurrent or progressive disease following multi-modal therapy (radiation
therapy, surgical resection or definitive chemoradiation for locally advanced
disease

- Eastern Cooperative Oncology Group (ECOG) PS 0 or 1

- Disease progression or recurrence after both a platinum doublet-based chemotherapy
regimen and at least one additional 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:

- Untreated central nervous system (CNS) metastases. Subjects are eligible if
metastases are 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 CA209-017 or CA184-104

- 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