Cetuximab as Therapy for Recurrent Non-Small Cell Lung Cancer Patients Who Have Received Prior Therapy

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)