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