Phase Ib/IIa Study of an Anti-Epidermal Growth Factor Receptor (EGFr) Antibody Cetuximab in Combination With Carboplatin-Paclitaxel in Patients With Chemotherapy-Naive Advanced 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.