Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

Inclusion Criteria:

Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
Evaluable or measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

Uncontrolled Central Nervous System (CNS) metastasis.
Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
Concurrent malignancy
Prior chemotherapy for NSCLC
Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
Superior vena cava syndrome contra-indicating hydration
White Blood Cells (WBC) < 3,000/mm³
Absolute neutrophile count (ANC) < 1,500/mm³
Platelet < 100,000/mm³
Hemoglobin (Hgb) < 9.0 g/dL
Total bilirubin > 1.5 x Upper limit of normal (ULN).
Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) > 5.0 x ULN.
Serum creatinine >1.25 x ULN and calculated creatinine clearance <60mL/min