Efficacy Study of Nivolumab Compared to Docetaxel in Subjects Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer

An Open-label Randomized Multinational Phase 3 Trial of Nivolumab Versus Docetaxel in Previously Treated Subjects With Advanced or Metastatic Non-small Cell Lung Cancer (CheckMate 078: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 078)

The purpose of this study is to determine whether Nivolumab improves life expectancy compared to Docetaxel in Subjects with Advanced or Metastatic Non-small Cell Lung Cancer who have failed prior platinum-based doublet chemotherapy.

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

Inclusion Criteria:

• Disease progression experienced during or after one prior platinum containing doublet chemotherapy
• Stage IIIb/IV or recurrent disease
• Male and Female ≥ 18 years of age
• Measurable disease per RECIST 1.1
• Performance Status ≤ 1

Exclusion Criteria:

• History of Carcinomatous meningitis
• Active Central nervous system (CNS) metastases
• History of auto immune diseases
• Prior treatment with Docetaxel
• Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or checkpoint pathways