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

Inclusion Criteria:

• Written informed consent before study-related activities
• Histologically or cytologically confirmed Stage IIIb with cytologically documented malignant pleural or pericardial effusion, Stage IV, or recurrent NSCLC after resection or radiation for earlier stage disease
• Measurable or evaluable disease (per modified RECIST)
• Male or female ≥ 18 years of age
• ECOG performance status of 0-1
• White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1.5 x 10(9)/L, platelet count ≥ 100 x 10(9)/L, and hemoglobin ≥ 9.5 g/dL
• Total bilirubin ≤ 1.5 x ULN
• AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver mets
• Serum creatinine ≤ 1.25 x ULN
• Recovery from prior surgery or radiation to Grade 1 or better toxicity
• Women of childbearing potential and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 wks after the study in such a manner that the risk of pregnancy is minimized
• WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration

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 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 wks 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
• MI within 6 months prior to study entry, uncontrolled CHF; 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 NCI-CTC 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.