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

NCT07491211 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Observational

Started

2019-07-19

Last updated

2026-03-27

Condition(s) studied

NSCLC (Advanced Non-small Cell Lung Cancer)Brain Metastases From Non-small Cell Lung Cancer (NSCLC)OsimertinibStereotactic Radiation

Investigational drug(s) / intervention(s)

Osimertinib →intracranial stereotactic radiotherapy

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * Leptomeningeal metastases at stage IV NSCLC diagnosis * 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 * Secondary or multiple primary tumors at stage IV NSCLC diagnosis * Patients received any adjuvant targeted therapy after previous surgery

Primary outcome measure(s)

Real-world Progression-Free Survival (rwPFS) — 5 years
The time from index date (i.e. first-line initiation) until documented disease progression or death, whichever occurs first. Any patient not known to have progressed or died at the time of analysis will have rwPFS censored at the date of last assessment showing no progression.

Trial sites (3)

Facility	City	Region
Fudan University Shanghai Cancer Center	Shanghai	China
Wuhan Tongji Hospital	Wuhan	Hubei
Shanghai Jiao Tong University Affiliated Chest Hospital	Shanghai	China

On this site

📄 Tagrisso (osimertinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07491211 on ClinicalTrials.gov ↗ ← All trials in China