- Histologically or cytologically proven diagnosis of Stage IIIB (N3 and/or T4) or
Stage IV Non-Small Cell Lung Cancer in patients 18-year-old or older, with Eastern
Cooperative Oncology Group (ECOG) performance status of 0 or 1 not amenable to
curative surgery or radiation therapy and an adequate organ function (bone marrow,
hepatic, renal, and cardiac) within 14 days prior to enrollment.
- Any prior treatment for Non-Small Cell Lung Cancer including chemotherapy, biologic
response modifiers or therapy with any investigational agents.
- Patients with known brain metastases, spinal cord compression, uncontrolled superior
vein cava syndrome or carcinomatous meningitis.
- Patients with gastrointestinal abnormalities including active gastrointestinal
bleeding, pre-diabetes (pre-fasting glycemia > 120 g/dL and/or glycosylate
haemoglobin level > 7.5%), known HIV or AIDS-related illness, significant active
cardiac disease or receiving chronic steroid therapy or concurrent use of growth
hormones or growth hormone inhibitors or aminoglycoside antibiotics should be
excluded from the study.