A Study of Oral Sapacitabine in Patients With Previously Treated Non-Small Cell Lung Cancer

Inclusion Criteria: * Histologically or cytologically confirmed recurrent NSCLC * Age of 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Measurable disease according to RECIST * Had only 1 prior chemotherapy regimen for metastatic or recurrent disease; patients who have received more than one prior chemotherapy regimens may participate in Part A of the study only. * Adequate bone marrow function * Adequate renal function * Adequate liver function * At least 3 weeks from prior systemic treatments including investigational anti-cancer therapy; at least 7 days from prior radiation therapy; and have recovered from prior toxicities * At least 3 weeks from major surgery * Patient must be able to swallow capsules * Agree to practice effective contraception during the entire study period and for one month after being discontinued from the study unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and willingness to sign the informed consent form Exclusion Criteria: * NSCLC histology contains a component of small cell lung cancer * Previously untreated CNS metastasis or progressive CNS metastasis documented by MRI scan performed at 4 weeks or longer after the last treatment for CNS metastasis * Currently receiving radiotherapy, biological therapy, or any other investigational agents * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Cancer other than NSCLC that has been treated with chemotherapy or biological therapy in the past 5 years with the exception of adequately treated in situ cervical cancer, and basal or squamous cell skin cancer; patients who received only hormonal therapy in the neoadjuvant or adjuvant setting in the past 5 years may participate in this study * Pregnant or lactating women * Known to be HIV-positive