A Phase 3 Randomized Study of Lonafarnib in Combination With Paclitaxel and Carboplatin Vs. Placebo in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer

Inclusion Criteria:

- Male or female

- Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer.
Patients must meet any subcriteria as detailed in the protocol.

- Age greater than or equal to 18 years old

- ECOG performance status of 0 to 1

- Prior diagnosis of brain metastases from NSCLC eligible provided that the brain
metastases have been adequately treated, patient is neurologically stable and no new
or progressive brain metastases identified.

- Meets protocol requirements for specified laboratory values

- Written informed consent

- Appropriate use of effective contraception if of childbearing potential

- Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided
they have been treated with no evidence of disease

Exclusion Criteria:

- Prior chemotherapy for any stage of NSCLC

- Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery
from prior procedures or therapy

- Concurrent treatment or treatment within the last 2 years for any other malignancy

- Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic
medication)

- Medical conditions that would interfere with taking oral medications

- Patients with bone metastases as the only site of disease

- Pregnant or nursing women

- Known HIV positivity or AIDS-related illness

- Patients with significant QTc prolongation at baseline