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Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC
Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Summary
Osimertinib, though a standard first-line treatment for EGFR-mutant advanced NSCLC, shows primary resistance in 10-30% of patients, leading to disease progression within 3-4 months. This resistance is linked to co-mutations in genes like TP53, RB1, and PIK3CA, among others. Studies indicate that Topo II inhibitor Etoposide (VP-16) can reduce cell survival, enhance DNA damage, and delay resistance in Osimertinib-resistant cells, suggesting a potential combination therapy to manage resistance.This study is a single-center, prospective, single-arm study evaluating the efficacy and safety of osimertinib combined with etoposide as a first-line treatment in patients with osimertinib-resistant or -insensitive advanced non-small cell lung cancer (NSCLC). The study focuses on patients with advanced NSCLC (stage IIIB or IV) with EGFR-sensitive mutations who developed slow resistance to osimertinib and for whom secondary biopsy after resistance did not identify any therapeutic targets.
Official title: A Single-Center, Prospective, Single-Arm, Observational Study Evaluating the Efficacy and Safety of Osimertinib Combined With Etoposide as First-Line Treatment in Patients With Osimertinib-Resistant or -Insensitive, Advanced EGFR-Mutant Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
93
Start Date
2024-06
Completion Date
2029-12
Last Updated
2024-05-30
Healthy Volunteers
No
Conditions
Interventions
Osimertinib
Etoposide Soft Capsules Dosage:25mg/tablet, 2 tablets/time, taken continuously for 21 days, and stopped for one week. Osimertinib Dosage:80mg/tablet, 1 tablet/time, QD, taken for two cycles.