This is a Phase 1b, open-label, multicentre study of AZD6094 in combination with gefitinib in patients with epidermal growth factor receptor (EGFR) mutation positive (m+) and progressed on EGFR Tyrosine kinase inhibitor (TKI) treatment.
Name: Volitinib
Name: gefitinib
Description: the grade of AE event according to CTC AE 4.0
Measure: Number of adverse events and serious adverse events Time: From ICF signed to within 28 days after the last doseDescription: Peak Plasma Concentration (Cmax)
Measure: The Pharmacokinetics (PK) profiles of AZD6094 Time: Cycle 1 Day1 and Day 15Description: Area under the plasma concentration versus time curve (AUC)
Measure: The Pharmacokinetics (PK) profiles of AZD6094 Time: Cycle 1 Day1 and Day 15Description: 6-months PFS, 12 months PFS and 24 month PFS
Measure: Progression-free survival (PFS) Time: from enrolled until progression or death due to any cause, assessed up to 2 yearDescription: CR+PR+SD
Measure: Disease control rate(DCR) Time: 12 weeks and 24 weeksAllocation: Non-Randomized
Parallel Assignment
There are 2 SNPs
3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients who are harbouring an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X). --- L858R ---
3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients who are harbouring an EGFR mutation known to be associated with EGFR-TKI sensitivity (including exon 19 deletion, L858R, L861Q, G719X). --- L858R --- --- L861Q ---