This is a single-arm, non-randomized multicentre phase 2 study in NSCLC patients with EGFR exon 20 insertion mutation, whose disease has progressed on standard chemotherapy.
Name: Osimertinib 80 MG [Tagrisso]
Description: Osimertinib 80mg once daily until disease progressionType: DrugOsimertinib
Description: Investigator-assessed, confirmed objective response by RECIST version 1.1
Measure: Objective response rate Time: Through study completion, an average of 1 yearDescription: AEs/SAEs as defined by NCI CTCAE version 4.0
Measure: Incidence of Treatment-Emergent Adverse Events Time: Through study completion, an average of 1 yearDescription: PFS as defined by RECIST version 1.1
Measure: Progression-free survival Time: From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 yearsDescription: OS as defined by RECIST version 1.1
Measure: Overall survival Time: Through study completion, an average of 2 yearsDescription: Duration of response as defined by RECIST version 1.1
Measure: Duration of response Time: Through study completion, an average of 1 yearSingle Group Assignment
There is one SNP
Osimertinib is an oral, potent, irreversible EGFR-TKI selective for sensitizing EGFR and EGFR T790M resistance mutations with a significant selectivity margin against wild-type EGFR. --- T790M ---