A Phase I-IIa Dose-Ranging Study of Pemetrexed (Alimta) Plus Cetuximab (Erbitux) in Patients With Recurrent Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN04-79

Inclusion Criteria:

- Histologic or cytologic diagnosis of NSCLC

- Recurrent or metastatic disease that is not amenable to curative therapyMeasurable
disease according to RECIST

- At least one prior platinum containing regimen for either locally advanced or
metastatic disease

- Prior chemotherapy must be completed at least 21 days prior to being registered for
protocol therapy and the subject must have recovered from the acute toxicity effects
of the regimen

- Ability and willingness to interrupt aspirin or other nonsteroidal anti-inflammatory
agents for a 5-day period

- Prior radiation therapy allowed to < 25% of the bone marrow

- Negative pregnancy test

Exclusion Criteria:

- No active infection that in the opinion of the investigator would compromise the
subject's ability to tolerate therapy.

- No serious concomitant systemic disorders that would compromise the safety of the
subject or compromise the subject's ability to complete the study, at the discretion
of the investigator.

- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the subject has
been disease-free for at least 2 years.

- No major thoracic or abdominal surgery within 30 days prior to being registered for
protocol therapy.

- No current breastfeeding