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

Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

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