Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC

CheckMate 057: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 057

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

Inclusion Criteria:

- Men & women ≥18 years of age

- Subjects with histologically or cytologically-documented non-squamous cell NSCLC who
present with Stage IIIB/IV disease or recurrent or progressive disease following
multimodal therapy (radiation therapy, surgical resection, or definitive
chemoradiation therapy for locally advanced disease) and who will receive study
therapy as second or third line of treatment for advanced disease

- Disease recurrence or progression during/after one prior platinum doublet-based
chemotherapy regimen for advanced or metastatic disease

- Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per
RECIST 1.1 criteria

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

- A 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 untreated central nervous system (CNS) metastases are excluded. Subjects
are eligible if CNS metastases are asymptomatic or 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 or recent history of known or suspected autoimmune disease.
Subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone
replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring
systemic treatment are permitted to enroll

- 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 (anti-PD-1), anti-programmed cell death
ligand 1 (anti-PD-L1), anti-programmed cell death ligand 2 (anti-PD-L2), anti-cluster
of differentiation 137 (anti-CD137), or anti-Cytotoxic T lymphocyte-associated antigen
4 (anti-CTLA-4) antibody (including Ipilimumab or any other antibody or drug
specifically targeting T-cell co-stimulation or checkpoint pathways)

- Prior treatment with Docetaxel

- Treatment with any investigational agent within 14 days of first administration of
study treatment