NCT03414814

Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Locally Advanced or Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	Osimertinib 80 MG [Tagrisso]	Osimertinib 80mg once daily until disease progression

Timeline

• Start date: 2018-01-04
• Primary completion: 2021-08-03
• Completion: 2021-08-03
• First posted: 2018-01-30
• Last updated: 2025-02-11
• Results posted: 2025-02-11

Locations

1 site across 1 country: South Korea