A Phase 1 Dose-Escalation Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

Inclusion Criteria

Inclusion Criteria (include but are not limited to):

- Histogically or pathologically determined relapsed/recurrent Stage IIIb (plueral
effusion) or IV NSCLC.

- Measurable or evaluable disease as defined by RECIST

- Must have failed at least one prior chemotherapy regimen or have refused
chemotherapy.

- ECOG perfromance status of 0,1, or 2.

Exclusion Criteria (include but are not limited to):

- Radiation therapy (excluding CNS therapy) < 2 weeks, chemotherapy, non-cytotoxic
investigational agents or high dose corticosteroids within 3 weeks of intitating
therpy or patients who have not recovered from adverse effects due to agents
administered more than 3 weeks earlier.

- Evidence of New York Heart Associatation Class III or greater cardiac disease.

- History of myocardial infarction, stroke, or cardiovascular intervention within the
last 12 months.

- Patients on anti-platlet drugs or anticoagulants such as Placix and Coumadin.

- Systemic central nervous system metastases. The patient must be stable after
radiotherapy for >/= to 2 weeks and off corticosteroids for >/= to 1 week.

- Pregnant or nursing women.

- Patients who are primarily refactory to erlotinib.