A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria:

- Must have advanced or metastatic non-small cell lung cancer that has not been
previously treated with any chemotherapy.

- Tumor/disease lesions that can be measured bidimensionally.

- Must be able to carry-out work of light or sedentary nature (e.g. light house work,
office work).

- Adequate recovery from recent surgery or radiation therapy.

- Must be at least 4 weeks from last major surgery or prior treatment with an
investigational agent. At least 12 weeks from any radiation therapy to chest.

- Accessible for treatment, follow-up and required visits at a participating center(s).

Exclusion Criteria:

- Prior chemotherapy or adjuvant chemotherapy for the treatment of lung cancer.

- Prior treatment with cetuximab or other epidermal growth factor (EGFR)-targeted
therapy.

- Prior severe infusion reaction to antibody therapy.

- Concurrent malignancy (previous malignancy without evidence of disease for 5 years
will be allowed to enter trial).

- Concurrent chemotherapy or therapy with another investigational agent not indicated
in the protocol.

- Serious uncontrolled medical disorders that would impair the ability to receive
therapy.

- History of myocardial infarction within prior 3 months, uncontrolled angina,
uncontrolled arrhythmia, or uncontrolled congestive heart failure.

- Symptomatic or uncontrolled metastases in the central nervous system. Subjects
receiving a glucocorticoid for central nervous system (CNS) metastases are not
eligible, but those receiving an anticonvulsant are eligible.

- Peripheral neuropathy >= grade 2 (Common Toxicity Criteria Adverse Event [CTCAE]
Version 3.0).

- Inadequate hematologic and/or liver and/or kidney function.

- Sexually active and fertile individuals or partners of these individuals who are
unwilling or unable to use an acceptable method of birth control for entire trial and
up to 4 weeks after the study.

- Women who are pregnant or breastfeeding.

- Women with a positive pregnancy test on enrollment prior to study drug
administration.

- Altered mental status or psychiatric condition that prohibits understanding or
rendering of consent.