A Phase I Study of FCN-411 in Advanced Non-small Cell Lung Cancer Chinese Patients With EGFR Positive Mutation

Inclusion Criteria: 1. Age 18 years and older. 2. Histological or cytological confirmed diagnosed advanced or metastatic NSCLC. 3. Documentation of disease progression while on previous continuous treatment with first-line EGFR TKI; patients must have confirmation of tumor EGFR activating mutations (exon 19 del, or exon 21 ins) and T790M status by biopsy sample or optical microscopy. 4. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG). 5. Have a life expectancy of at least 12 weeks. 6. Have measurable disease based on RECIST v1.1. Note: previously irradiated not chosen, unless disease progression after irradiation. 7. Adequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values: 1. Neutrophils (absolute value) ≥ 1.5×10\^9/L; 2. Hemoglobin ≥ 90 g/L; 3. Platelet ≥ 90×10\^9/L; 4. Serum total bilirubin ≤ 1.5× ULN（for Patients with Gilbert Syndrome, total bilirubin ≤ 3×ULN and bilirubin ≤ 1.5×ULN should be permitted） 5. Aspartate aminotransferase、alanine aminotransferase ≤ 2.5×ULN; for patients with hepatic metastases, AST、ALT ≤ 5×ULN; 6. Creatinine \< 1.5×ULN creatinine clearance rate≥ 45 mL/min (Cockcroft Gault for calculating) 8. Female subjects have a negative urine or serum pregnancy. Exclusion Criteria: 1. Treatment with any of the following: 1. Treatment with an EGFR TKI within 14 days or about 5 half-lives, whichever is the longer, of the first dose of study drug; 2. Any cytotoxic chemotherapy, investigational agents or anticancer drugs for the treatment from a previous treatment regimen within 14 days of the first dose of study treatment; 3. Major surgery within 4 weeks of the first dose of study treatment; 4. Systemic irradiation including whole brain irradiation; 5. Previously treated by EGFR-TKI for T790M (for example Osimertinib). 2. P-glycoprotein inducers (for example Rifampicin) or inhibitors (for example ritonavir) are required during the study. 3. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy. 4. Meningeal metastases or CNS metastasis received intervention or malignancy related epilepsy; brain metastases without symptom are eligible. 5. Any serious or uncontrolled systemic disease, including but not limited to: 1. Uncontrolled hypertension; 2. Active hemorrhage; 3. Active infections including hepatitis B, or hepatitis C; 4. Human immunodeficiency virus positive; 5. Child Pugh C; 6. Bullous or exfoliative skin diseases; 7. Severe malnutrition; 8. History of keratitis or ulcerative keratitis or dry eye; 9. Uncontrolled large amount of third interstitial fluid retention; 10. Other serious diseases or mental disorders or laboratory abnormalities. 6. Cardiac function and disease are consistent with the following: 1. QTc\> 470 milliseconds from 3 electrocardiograms (ECGs); 2. Any clinically important abnormalities in rhythm; 3. Any factors that increase the risk of QTc prolongation; 4. Congestive heart failure ≥ grade 3 by New York Heart Association (NYHA); 7. Previous history with interstitial lung disease、drug-induced interstitial lung disease or radiation pneumonitis require hormone therapy, or other active interstitial lung diseases required treatments. 8. Lung function met one of the following criteria: 1. Oxygen saturation ≤ 88%; 2. The first second forced expiratory volume\< 50% of the predicted value; 3. Diffusion capacity for CO \< 50% of the predicted value. 9. Dysphagia, or active digestive system diseases or medical conditions potentially affect FCN-411 absorption. 10. Hypersensitivity to FCN-411 or similar compounds or excipients. 11. Pregnant or lactating women.