Study of Cetuximab in Combination With Carboplatin-Paclitaxel in Non-Small Cell Lung Cancer

Inclusion Criteria:

The following inclusion criteria must be met:

• The patient has stage IV NSCLC with either present or prior histologic or pathologic confirmation of NSCLC
• The patient has uni-dimensionally measurable stage IV NSCLC
• The patient has chemotherapy-naive stage IV NSCLC. The patient may have recurrent disease if prior radiation therapy was received. Pathological confirmation of recurrence is required for disease within a radiation portal.
• The patient's ECOG performance status is ≤ 2 at study entry.
• The patient has immunohistochemical evidence of EGFr expression (≥1+). Patients who do not have tumor tissue available for EGFr testing will undergo a biopsy of an accessible tumor. EGFr expression must be confirmed prior to study entry.
• The patient has given signed informed consent.
• The patient is 18 years of age or older.
• The patient has adequate hematologic function, as defined by an absolute neutrophil (ANC)≥ 1,500/mL3 , a WBC count≥3,000/mL3, a platelet count ≥100,000/mL3, and a hemoglobin level ≥9g/dL.
• The patient has adequate hepatic function as defined by a total bilirubin level ≤1.5 X the upper limit of normal (ULN) and an alkaline phosphatase, AST, and ALT level ≤2.5 X the ULN.
• The patient has adequate renal function with a serum creatinine level ≤1.5 mg/dL or a creatinine clearance ≥60 cc/minute.
• The patient is disease free from a previously treated malignancy, other than the disease under study, for greater than 3 years (patients with a history of a previous basal cell carcinoma of the skin or preinvasive carcinoma of the cervix will not be excluded).
• The patient, if a woman, agrees to use effective contraception if childbearing potential exists. The patient, if a man, agrees to use effective contraception.

Exclusion Criteria:

The following ten exclusion criteria are for this study:

• The patient has received prior cetuximab therapy.
• The patient has disease amenable to curative surgery.
• The patient has received prior chemotherapy for the disease under study.
• The patient has received wide field radiation therapy within 4 weeks prior to the first infusion of cetuximab. The patient may have local irradiation for the management of tumor-related symptoms.
• The patient has undergone major thoracic or abdominal surgery within 30 days (to allow for a full recovery)prior to the first infusion of cetuximab.
• The patient has a history of uncontrolled angina,arrhythmias, or congestive heart failure.
• The patient has uncontrolled seizure disorder, active neurological disease (not tumor related), or grade ≥2 neuropathy (patients with meningeal or central nervous system [CNS] involvement by the tumor will be eligible).
• The patient has a history of hypersensitivity to Cremophor EL.
• The patient, if a woman, is pregnant (confirmed by serum BHCG) or breastfeeding.
• The patient has received any investigation agents within 30 days of study entry.