Inclusion Criteria:

- Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC

- Patients must have progressed while receiving treatment with a tyrosine kinase
inhibitor targeting the EGFR pathway

- Measurable disease, as defined by RECIST criteria

- Patients must have a suitable frozen or paraffin-embedded tissue sample available for
EGFR mutational analysis. Prior EGFR mutational analyses are allowable

- Patients with asymptomatic brain metastasis are eligible; however, they must have
completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be
clinically stable

- ECOG Performance Status 0-2

- 18 years of age or older

- Negative pregnancy test within 7 days of treatment or be categorized as not of
child-bearing potential

- Bone marrow function, renal function, hepatic function as outlined in protocol

Exclusion Criteria:

- Women who are pregnant of breastfeeding

- Active concurrent malignancy

- Major thoracic or abdominal surgery within 30 days prior to the first infusion of
cetuximab

- Significant history of uncontrolled cardiac disease

- Uncontrolled seizure disorder, or active neurological disease

- Prior severe infusion reactions to a monoclonal antibody

- Prior chemotherapy regimen within 21 days prior to study entry

- Any EGFR tyrosine kinase inhibitor within 14 days of study entry

- Radiation therapy within 14 days prior to the first infusion of cetuximab

- Acute hepatitis or known HIV

- Active or uncontrolled infection

- Any concurrent chemotherapy or any other investigational agent(s)