An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- ECOG Status: PS 0-1 & PS 2

- Subjects with histologically or cytologically-documented SqNSCLC

- Subjects must have experienced disease progression or recurrence during or after one
prior platinum doublet-based chemotherapy regimen

- Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria

- Subjects with treated or asymptomatic CNS metastases

- Prior palliative radiotherapy must have been completed at least 14 days prior to study
drug administration

- Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy,
immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or
standard or investigational agents for treatment of NSCLC, must be completed 28 days
prior to the first dose of nivolumab

- Males and Females, ages 18 or older

Exclusion Criteria:

- Subjects with untreated, symptomatic CNS metastases

- Subjects with carcinomatous meningitis

- Subjects with active, known or suspected autoimmune disease.

- Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or
drug specifically targeting T-cell costimulation or checkpoint pathways) or who have
previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.