A Safety Trial of Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Chemotherapy Regimen

Inclusion Criteria

• •1\. Target Population
• •Subjects with histologically-or cytologically-documented NSCLC \[squamous (SQ) or nonsquamous (NSQ)\] 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 multimodal therapy (radiation therapy, surgical resection or definitive chemoradiotherapy for locally advanced disease)
• •Subjects must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced or metastatic disease
• •Each subsequent line of therapy must be preceded by disease progression. A switch of an agent within a regimen in order to manage toxicity does not define the start of a new line of therapy
• •Maintenance therapy following platinum doublet-based chemotherapy is not considered as a separate regimen of therapy
• •Subjects who received platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, and developed recurrent (local or metastatic) disease within 6 months of completing therapy are eligible
• •Subjects with recurrent disease \>6 months after platinum-containing adjuvant, neoadjuvant or definitive chemoradiation therapy given for locally advanced disease, who also subsequently progressed during or after a platinum doublet-based regimen given to treat the recurrence are eligible
• •Experimental therapies when given as separate regimen are considered as separate line of therapy
• •Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria (radiographic tumor assessment performed within 28 days of first dose of study drug) or clinically apparent disease that the investigator can follow for response per RECIST 1.1
• •Eastern Cooperative Oncology Arm (ECOG) performance status (PS)
• •PS 0 to 1
• •PS 2