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

A Phase II Trial of Cetuximab (c225) as Therapy for Recurrent Non-Small Cell Lung Cancer in Patients Who Have Received Prior Therapy With Tyrosine Kinase Inhibitor Directed Against the EGFR Pathway

The purpose of this research study is to find out how well cetuximab works in treating NSCLC in patients who have been previously treated with a class of drug called tyrosine kinase inhibitor (TKI). Cetuximab is a protein that is designed to block a substance in cancer cells called "epidermal growth factor receptor" or EGFR. EGFR helps cancer cells grow.

• Participants on this study will receive cetuximab by infusion intravenously once per week and may continue to receive weekly cetuximab infusions until their disease progresses or they experience unacceptable side effects.
• The following will be performed every 4 weeks while they are receiving study treatments: Physical examination; performance status; and blood work. A CT scan of the chest and upper abdomen will be performed every 8 weeks.

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)