Phase II Study of Cetuximab in Combination With Carboplatin and Docetaxel for Patients With Advanced Non-Small Cell Lung Cancer

Inclusion Criteria: * Histologically/cytologically confirmed stage IIIB (pleural or pericardial effusion) or stage IV NSCLC. * Age \> 18 years. * ECOG PS 0-1. * No prior chemotherapy for NSCLC. * Measurable disease by RECIST criteria. * Signed IRB-approved informed consent. * Adequate bone marrow function defined by: peripheral absolute neutrophil count (ANC) \>1500/microL, hemoglobin \>9.0 g/dL, and platelet count \>100,000/microL. * Adequate renal function as defined by serum creatinine level less than institutional upper limit of normal (ULN) or calculated/measured creatinine clearance \> 65 mL/min. * Adequate liver function defined as: serum total bilirubin \<ULN, serum aspartate aminotransferase (AST) \<2.5 times ULN. * Estimated life expectancy \>12 weeks. Exclusion Criteria: * Untreated clinically active brain metastasis. * Radiotherapy within 2 weeks prior to registration or previous irradiation to the only area of measurable disease. * Treatment with any investigational therapy within 4 weeks prior to registration. * Prior therapy with an agent that is known to specifically and directly target the EGFR pathway. * History of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years. * Patients in their reproductive age group should consent to use an effective method of birth control while on treatment and for at least 3 months thereafter. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study. * Major surgery within 3 weeks prior to registration. * Use of immunosuppressive agents including systemic corticosteroids within 4 weeks prior to registration (corticosteroids are permitted as physiological replacement therapy or as supportive care for nausea and emesis). * Known history of human immunodeficiency virus infection. * Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator. * Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. * Concurrent serious infection. * History of known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80. * History of prior severe infusion reaction to a monoclonal antibody. * Patient has \>Grade 2 peripheral neuropathy within 14 days prior to registration