This is a Phase 1, open-label study of SH-1028 with dose escalation and dose expansion cohorts in locally advanced or metastatic non-small-cell lung cancer (NSCLC) patients who have progressed following prior therapy with an epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor (TKI) agent.
Name: SH-1028
Description: Starting dose 60mg,oral administered once daily.If tolerated subsequent cohorts will test increasing doses (100mg,200mg,300mg,400mg) of SH-1028.Type: DrugSH-1028
Single Group Assignment
There are 2 SNPs
5. Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria while on continuous treatment with an EGFR TKI(PR/CR, or SD continued ≥6 months). --- L858R ---
5. Confirmation that the tumor harbors an EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) or must have experienced clinical benefit from EGFR TKI, according to the Jackman criteria while on continuous treatment with an EGFR TKI(PR/CR, or SD continued ≥6 months). --- L858R --- --- L861Q ---