Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer

Phase Ib, IIa Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Chemotherapy-Naive Stage IV Non-Small Cell Lung Cancer

The objective is to evaluate the toxicity profile, response rate, and time to progression of Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with advanced non-small cell lung cancer with positive EGFr expression.

The primary objective of this study is to evaluate the safety profile of Cetuximab when used in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC).

Also, the study will determine the response rate in patients with EGFr positive chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC) treated with Cetuximab in combination with gemcitabine and carboplatin as well as determine the time to progression in patients with EGFr positive chemotherapy-naive, stage IV NSCLC treated with Cetuximab in combination with gemcitabine and carboplatin.

Inclusion Criteria:

• Have a diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC).
• Have uni-dimensionally measurable and/or evaluable advanced NSCLC.
• Have Stage IV or recurrent disease following radiation therapy.
• Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at study entry.
• Have given signed informed consent.
• Be at least 18 years of age.
• Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.
• Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos, AST and ALT less than or equal to 2.5 x upper limits of normal.
• Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine clearance greater than or equal to 60 cc/minute.
• Be disease free from a previously treated malignancy for more than three years. Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.
• Agree to use effective contraception if procreative potential exists.
• Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.

Exclusion Criteria:

• Have received prior murine monoclonal antibody or Cetuximab therapy.
• Have disease amenable to curative surgery.
• Have received prior chemotherapy.
• Have received radiation therapy within 3 weeks prior to the first infusion of Cetuximab.
• Have a history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities, in the judgment of the PI.
• Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher neuropathy.
• Be pregnant or breast-feeding.
• Have received any investigational agent(s) within 1 month of study entry.