A Randomized Multicenter Phase II Study of Gemcitabine/Platinum/Cetuximab Versus Gemcitabine/Platinum 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.

- Must not have received cetuximab or any medications that target the same pathway as
cetuximab (such as Iressa or Tarceva).

- Must not have had hypersensitivity or severe allergic reactions to any monoclonal
antibodies and must not have severe restrictive or interstitial lung disease.

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

- It must be at least 4 weeks since last major surgery or prior treatment with an
investigational product and at least 12 weeks from any radiation therapy to the
chest.

Exclusion Criteria:

- Women who are pregnant or breastfeeding.

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

- Any concurrent malignancy (subjects with a previous malignancy but without evidence
of disease for 5 years will be allowed to enter the trial).

- Symptomatic or uncontrolled metastases in the central nervous system (CNS).

- Peripheral neuropathy.

- Inadequate hematologic function defined by an absolute neutrophil count (ANC)
<1,500/mm^3, a platelet count <100,000/mm^3, or a hemoglobin level < 9g/dL.

- Inadequate liver function.

- Inadequate kidney function.