An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

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