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

NCT07491211 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Osimertinib

Eligible patients received first-line osimertinib monotherapy for systemic treatment.

RADIATION

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-19
Primary Completion
2025-03-31
Completion
2026-03-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07491211 on ClinicalTrials.gov