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)