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.
EGFR exon 20 insertion-mutant NSCLCs are generally resistant to 1st-generation EGFR tyrosine kinase inhibitors (TKIs) as well as 2nd-generation EGFR TKIs (overall response rates of 0-8.7%). 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. Osimertinib is potent with a wide therapeutic window in Ba/F3 cells with EGFR exon 20 insertion mutations. Therefore, this study will be performed to investigate the efficacy of osimertinib in NSCLC patients with EGFR exon 20 insertion mutation
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Osimertinib 80mg once daily until disease progression
Seoul National University Hospital
Seoul, South Korea
Objective Response Rate
Investigator-assessed, confirmed objective response by RECIST version 1.1
Time frame: Until study completion, from date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. (upto about 29months)
Serious Adverse Events
AEs/SAEs as defined by NCI CTCAE version 4.0
Time frame: From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawal, whichever came first. Until study completion. (upto about 29months)
Progression-free Survival
PFS as defined by RECIST version 1.1
Time frame: From date of initiation until the date of first documented progression, unacceptable toxicities or withdrawl, whichever came first. Until study completion. (upto about 29months)
Overall Survival
OS as defined by RECIST version 1.1. The time from the first date of IP administration to the date of death.
Time frame: From the first date of IP administration to the date of death. (upto about 29months)
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