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Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

Locally Advanced or Metastatic NSCLC Clinical Trial

Official title:
Phase II Study of Osimertinib in NSCLC Patients With EGFR Exon 20 Insertion Mutation

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03414814
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 2
Start date January 4, 2018
Completion date August 3, 2021
View Details
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