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Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases
Sponsor: Fudan University
Summary
The goal of this retrospective real-world study is to evaluate the effectiveness and safety of first-line osimertinib combined with early intracranial stereotactic radiotherapy (SRT) in patients with EGFR-mutant non-small cell lung cancer (NSCLC) with symptomatic brain metastases. Eligible patients include adults with stage IV EGFR-mutant NSCLC who received first-line osimertinib monotherapy and early intracranial SRT. Data will be extracted from hospital medical records across multiple centers. The primary endpoint is real-world progression-free survival (rwPFS). Secondary endpoints include overall survival (OS), rwPFS2, time to next treatment or death (TTNT), and time to treatment discontinuation or death (TTD). Exploratory endpoints include CNS progression patterns, CNS progression-free survival (CNS PFS), CNS objective response rate (CNS ORR), and incidence of symptomatic CNS radiation necrosis.
Official title: Osimertinib With Intracranial Stereotactic Radiotherapy for Newly Diagnosed, Treatment Naive EGFR Mutation Non-Small Cell Lung Cancer With Symptomatic Brain Metastases: A Retrospective, Multicenter, Real-world Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2019-07-19
Completion Date
2026-03-31
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Osimertinib
Eligible patients received first-line osimertinib monotherapy for systemic treatment.
intracranial stereotactic radiotherapy
Early intracranial stereotactic radiotherapy (SRT) was administered for brain metastases before disease progression on first-line osimertinib. Treatment and follow-up data were collected retrospectively from hospital medical records.
Locations (3)
Fudan University Shanghai Cancer Center
Shanghai, China, China
Wuhan Tongji Hospital
Wuhan, Hubei, China
Shanghai Jiao Tong University Affiliated Chest Hospital
Shanghai, China