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
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.
• Male or female, aged \>=18 years and \<75 years
• Clinical diagnosis of NSCLC.
• Subjects must have experienced disease progression after standard therapy, or be intolerant to or unsuitable for standard therapy, or have no available standard therapy.
• Subjects must provide 3-5 archived tumor tissue slides
• Subjects must have non-squamous NSCLC with one or more positive EGFR mutations
• At least one measurable lesion according to RECIST v1.1 (In Phase Ia, lesions that are assessable but not measurable are acceptable).
• ECOG performance status score of 0-1
• Life expectancy \>=12 weeks.
• (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, \<=5 × ULN; (3)Renal Function:Creatinine \<=1.5 × ULN; if \>1.5 × ULN, creatinine clearance ≥50 mL/min \[Creatinine clearance calculated using the Cockcroft-Gault formula (see Appendix 2: Cockcroft-Gault Formula)\] (4)Coagulation Panel Note: For subjects receiving anticoagulant therapy, the investigator will determine whether the international normalized ratio (INR) and activated partial thromboplastin time (APTT) are within a safe therapeutic range. INR \<= 1.5×ULN;APTT \<= 1.5×ULN.
⁃ Contraception is required during the trial period.