A Phase II 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