This is a multi-center, open-label, dose escalation and phase I/II study, consisting of dose escalation in Part A and phase II study in Part B.
Name: AZD3759
Description: Strength: 50mg/tablet, 100mg/tablet Dosage and administration: Twice daily administration under fasting state.Type: Drugexperimental group
Description: AE.SAE,vital signs, physical examination,laboratory examinations etc.
Measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Time: 21 days after the first doseDescription: ORR, DCR, DOR, PFS and tumor size changing compared with baseline according to RECIST 1.1
Measure: anti-tumor activity Time: every 6 weeksDescription: Peak Plasma Concentration (Cmax)
Measure: Peak Plasma Concentration (Cmax) Time: Pre-dose and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h(C0D2) and 48h(C0D3) after the first single-dose(C0D1) ;Pre-dose of C1D1,C1D8, C1D15, C1D21 and C2D1 and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h post dose on C1D21 during multiple dosing.Description: Area under the plasma concentration versus time curve (AUC)
Measure: Area under the plasma concentration versus time curve (AUC) Time: Pre-dose and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h(C0D2) and 48h(C0D3) after the first single-dose(C0D1) ;Pre-dose of C1D1,C1D8, C1D15, C1D21 and C2D1 and 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h post dose on C1D21 during multiple dosing.Single Group Assignment
There is one SNP
3. Histologically or cytologically confirmed non-small cell lung cancer with activating mutation in EGFR gene (including Exon19Del and/or L858R). --- L858R ---