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
- 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
- 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
- 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