A Study of TY-9591 in Advanced Non-small Cell Lung Cancer(NSCLC) Patients With EGFR Positive Mutation

Exclusion Criteria

• •1. Treatment with any of the following:
• •1. Treatment with an EGFR TKI within 14 days or about 5x half-life, 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 4 weeks of the first dose of study treatment;
• •3. Major surgery within 4 weeks of the first dose of study treatment;
• •4. Radiotherapy with a limited field of radiation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 4 weeks of the first dose of study treatment;
• •5. Previously treated by other third-generation epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI) for T790M (for example Osimertinib).
• •6. Patients currently receiving (or at least within 1 week prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4.
• •2. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2, prior platinum-therapy related neuropathy.
• •3. Spinal cord compression or brain metastases unless asymptomatic.
• •4. Dysphagia, or active digestive system diseases or previous significant bowel resection or medical conditions potentially affect TY-9591 absorption.
• •5. Cardiac function and disease are consistent with the following:
• •1. Corrected QT interval(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. Left ventricular ejection fraction (LVEF) \<50%;
• •6. Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.
• •7 .Previous history of interstitial lung disease(ILD)、drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.
• •8\. Previous allogeneic bone marrow transplant. 9. Hypersensitivity to TY-9591 or similar compounds or excipients. 10.Pregnant or lactating women.