A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (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.