Trials / Active Not Recruiting
Active Not RecruitingNCT07491211
Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-07-19
- Primary completion
- 2025-03-31
- Completion
- 2026-03-31
- First posted
- 2026-03-24
- Last updated
- 2026-03-27
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07491211. Inclusion in this directory is not an endorsement.