Randomized, Open Label, Stratified Phase 2 Trial of Gemcitabine, Carboplatin, and Cetuximab With Vs. Without IMC-A12 in Chemotherapy-Naive Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria:

- Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC

- Has metastatic disease

- Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors
(RECIST)

- Has adequate hematologic function

- Has adequate hepatic function

- Has adequate renal function

- Women of childbearing potential must agree to use adequate contraception (hormonal or
barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation

Exclusion Criteria:

- Has uncontrolled brain metastases

- Has leptomeningeal disease

- Has received previous chemotherapy for NSCLC (patients who have received adjuvant
chemotherapy are eligible if the last administration of the prior adjuvant regimen
occurred at least 6 months prior to randomization)

- Receiving any other investigational agent(s)

- Has a history of treatment with other agents targeting the IGF or the EGF receptor

- Has a known allergy / history of hypersensitivity reaction to any of the treatment
components

- Has poorly controlled diabetes mellitus. Patients with a history of diabetes mellitus
are allowed to participate, provided that their blood glucose is within normal range
(fasting glucose < 160 mg/dL or below the ULN and hemoglobin A1C ≤ 7%) and that they
are on a stable dietary or therapeutic regimen for this condition

- Has an uncontrolled intercurrent illness

- Pregnant or lactating

- Has a history of another primary cancer, with the exception of: a) curatively
resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in
situ; or c) other primary solid tumor treated with curative intent and no known
active disease present and no treatment administered during the last 3 years

- Has superior vena cava syndrome contraindicating hydration

- Has current clinically-relevant coronary artery disease (New York Heart Association
III or IV) or uncontrolled congestive heart failure

- Has any NCI-CTCAE Version 3.0 Grade ≥ 2 peripheral neuropathy

- Has significant third space fluid retention, requiring repeated drainage