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: 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.Allocation: N/A
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 ---