Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in Non Small Cell Lung Cancer Patients

Inclusion Criteria:

1. Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC
2. Patients with EGFR mutation-positive tumor
3. Malignancy that has progressed after at least two prior chemotherapy regimens, including EGFR TKI (epidermal growth factor receptor tyrosine kinase inhibitors)
4. If previously treated with other chemotherapy, radiation therapy, surgery or hormone therapy, at least 2 weeks should have elapsed from the last regimen prior to study entry. (if the last regimen includes mitomycin, at least 6 weeks should elapse), and any toxic effect of prior therapy should resolve to a Grade 1 or less.
5. Patients must be 20 years of age or older
6. Patients must have an ECOG performance status of 2 or less
7. Estimated life expectancy of at least 12 weeks

8. Subjects with adequate bone marrow (WBC ≥ 4,000/mm3, Platelet ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL, ANC ≥ 1,500/mm3), renal (Creatinine ≤ 1.5mg/dl) and hepatic (AST/ALT/ALP ≤ 3xULN, Total bilirubin ≤ 2.0mg/dL) function. No significant heart and lung disease.

   * For subjects with a liver metastases, AST/ALT/ALP ≤ 5xULN is allowed; and for subjects with bone marrow metastases, ALP ≤ 5xULN is allowed

9. Subjects who have provided voluntary consent to participate in the study, and signed the written consent document.

Exclusion Criteria:

1. Hematologic malignancies such as leukemia or uncontrolled infectious/neurological disease (a patient with an active bacterial infection requiring treatment with parenteral antibiotics are excluded; however, the patient may be eligible if the infection has completely resolved or controlled).
2. Symptomatic or uncontrolled central nervous system metastases
3. Patients who had previously received, or is planning to receive, the bone marrow transplant
4. Patients with parenchymal lung disease, including pulmonary fibrosis
5. LVEF (left ventricular ejection fraction) < 40% or NYHA (New York Heart Association) Class III or IV heart failure
6. Patients who are unable to take tablets orally or have a clinically significant gastrointestinal disorder, which may interfere with administration, metabolism and absorption of the investigational drug.