NOV120101 Phase 2 Study in NSCLC Patients With Aquired Resistance to 1st Generation EGFR Tyrosine Kinase Inhibitors

Exclusion Criteria

• •1. Patients who receive IP within 3 days from prior treatment with gefitinib or erlotinib
• •2. NCI-CTCAE grade \> 1 adverse events due to treatment with gefitinib or erlotinib
• •3. Prior systemic chemo, immuno, hormonal and/or biological therapy except gefitinib or erlotinib within 4 weeks before IP administration
• •4. Acquired resistance to EGFR TKI due to conversion of adenocarcinoma into small cell lung cancer
• •5. Patients who received major surgery within 4 weeks before IP administration
• •6. Symptomatic CNS metastases (patients with radiologically and neurologically stable metastases and being off corticosteroids for at least 4 weeks are able to participate in this trial.)
• •7. History of other malignancies except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for ≥ 3 years and considered to be cured by investigator's judgment
• •8. Known pre-existing interstitial lung disease (ILD)
• •9. NYHA class III or IV heart failure, uncontrolled hypertension, unstable angina or myocardial infarction within 6 months, poorly controlled arrhythmia or other clinically significant cardiovascular abnormalities at investigator's discretion
• •10. Patients whose left ventricle ejection fraction (LVEF) is below the institutional lower limit of normal (if no lower limit of normal is defined in the site, the lower limit is 50%.)
• •11. Patients with known active hepatitis B, HIV infection, or other uncontrolled infectious disease
• •12. Clinically significant or recent acute gastrointestinal disorders with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption disorders, CTCAE grade ≥ 2 diarrhea due to any etiology)
• •13. Patients who cannot receive IP by mouth and be diagnosed with clinically significant gastrointestinal disorders which can prevent administration, transit or absorption of the IP
• •14. Pregnancy or breast-feeding
• •15. Women of childbearing potential (WOCBP) or men who are unwilling to use adequate contraception or be abstinent during the trial and for at least 2 months after the end of treatment
• •16. Patients who received other investigational products except gefitinib and erlotinib within 4 weeks before participation
• •17. Patients who cannot participate in this trial by investigator's judgment