Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC

Exclusion Criteria

• •WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study
• •Women who are pregnant or breastfeeding
• •Women with a positive pregnancy test during screening or prior to study drug administration
• •Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential
• •Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is allowed if completed at least 12 months before study entry
• •Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior treatment with monoclonal antibodies targeting receptors other than the EGFR, such as bevacizumab, is allowed if completed \> 30 days prior to randomization
• •Treatment with any investigational agent(s) within 4 weeks prior to study entry
• •Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted therapy) other than protocol therapy
• •Carcinoid, atypical carcinoid or small cell lung cancer
• •Symptomatic or uncontrolled mets in the central nervous system
• •Prior invasive malignancy requiring ongoing therapy within the past year
• •Active infection (infection requiring intravenous \[IV\] antibiotics), including active tuberculosis, known and declared HIV
• •Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment
• •Known allergic/hypersensitivity reaction to any of the components of study treatments
• •Peripheral neuropathy ≥ Grade 2, as assessed by Common Terminology Criteria for Adverse Events, version 3.0
• •History of significant neurologic or psychiatric disorders including but not limited to dementia, seizures, and bipolar disorder
• •Medical or psychological condition that would not permit the patient to complete the study or sign informed consent
• •Known drug abuse
• •Patients of all races and ethnic groups are eligible for this trial.