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

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.