Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases

Sponsor
Fudan University
Study ID
NCT07491211
Status
Active Not Recruiting

Conditions

  • Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
  • NSCLC (Advanced Non-small Cell Lung Cancer)
  • Osimertinib
  • Stereotactic Radiation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Eligible patients received first-line osimertinib monotherapy for systemic treatment.
  • intracranial stereotactic radiotherapy — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Jul 19, 2019
Status verified
Mar 2026
Primary completion
Mar 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: First-line osimertinib plus early intracranial SRT
    Patients receiving first-line osimertinib combined with early intracranial stereotactic radiotherapy

Primary Outcome Measure

Real-world Progression-Free Survival (rwPFS) [ Time Frame: 5 years ]

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