NCT07491211Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 19 Jul 2019
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Fudan University
- Diseases
- Lung cancer
- NCT number
- NCT07491211
What you commit to
- Study type: Observational
- Planned participants: 300
- From 19 Jul 2019 to the primary completion date, 31 Mar 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Whole brain radiotherapy treated BM during observation period
- Patients received other systemic anti-tumor therapy in addition to osimertinib as 1L treatment during observation period
- Patients received any adjuvant targeted therapy after previous surgery
Other
- Leptomeningeal metastases at stage IV NSCLC diagnosis
- Secondary or multiple primary tumors at stage IV NSCLC diagnosis
Who the study is looking for
- Age ≥18 years, Male or female
- Pathologically confirmed Stage IV metastatic non-squamous non-small cell lung cancer (NSCLC) with documented positive EGFR sensitive mutation (EGFR 19del and L858R) and MRI confirmed brain metastases, diagnosed within 6 weeks prior to treatment initiation within baseline period
- Received first-line osimertinib monotherapy during observation period
- Upfront brain SRT during observation period
- Baseline ECOG scored 0-2
- Symptomatic brain metastases during baseline period\*
- Complete imaging evaluation of systemic lesions (including brain MRI) during baseline period and before osimertinib treatment
- At least 1 follow-up brain MRI during observation period
- Baseline BM: ≤10 Brain metastases, largest tumor \<10 mL in volume and \<3 cm in longest diameter; total cumulative volume ≤15 ml \*Symptomatic brain metastases are defined as any neurological symptom in relation to the diagnosed BM, occurred within 30 days after brain metastases diagnosis.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Jiao Tong University Affiliated Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Wuhan Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.