A Phase l Clinical Study to Evalute the Safety,Tolerability,Pharmacokinetic Characteristics,and Preliminary Anti-tumor Efficacy of HJ-004-02 Tablets in Patients With Non-squamous Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutations
Trial Parameters
Brief Summary
Single dose: Fasting, oral administration, as a single dose, taken with warm water. Multiple doses: Fasting, oral administration, as a single dose, taken with warm water, once daily (dosing frequency may be adjusted based on study data), with 28 days as one cycle.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, aged \>=18 years and \<75 years 2. Clinical diagnosis of NSCLC. 3. Subjects must have experienced disease progression after standard therapy, or be intolerant to or unsuitable for standard therapy, or have no available standard therapy. 4. Subjects must provide 3-5 archived tumor tissue slides 5. Subjects must have non-squamous NSCLC with one or more positive EGFR mutations 6. At least one measurable lesion according to RECIST v1.1 (In Phase Ia, lesions that are assessable but not measurable are acceptable). 7. ECOG performance status score of 0-1 8. Life expectancy \>=12 weeks. 9. (1) Hematologic Function:Absolute neutrophil count (ANC) \>= 1.5×10\^9/L;Platelet count (PLT) \>= 100×10\^9/L;Hemoglobin (HGB) \>=9.0 g/dL; (2)Hepatic Function:Total bilirubin (TBIL) \<=1.5 × upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) For those without liver metastases, \<=2.5 × ULN, orFor those with liver metastases,