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

NCT07491211 | Active Not Recruiting

• 1 other identifier: ESR-24-22678
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief 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); Osimertinib; Stereotactic Radiation; Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Keywords

NSCLC; brain metastases; Osimertinib; Stereotactic Radiation

Outcome Measures

Primary Outcomes (1)

• Real-world Progression-Free Survival (rwPFS)

  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.

  5 years

Secondary Outcomes (4)

• Overall Survival (OS)

  5 years

• rwPFS2

  5 years

• TTNT (Time to Next Treatment or Death)

  5 years

• TTD (Time to Treatment Discontinuation or Death)

  5 years

Study Arms (1)

First-line osimertinib plus early intracranial SRT

Patients receiving first-line osimertinib combined with early intracranial stereotactic radiotherapy

Drug: Osimertinib; Radiation: intracranial stereotactic radiotherapy

Interventions

Osimertinib DRUG

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

First-line osimertinib plus early intracranial SRT

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.

First-line osimertinib plus early intracranial SRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include Stage IV EGFR-mutant NSCLC patients with symptomatic brain metastases who were initially treated with first-line Osimertinib and upfront intracranial SRT during the enrollment period meeting the inclusion and exclusion criteria. First-line therapy must be initated within 6 weeks after initial diagnosis of stage IV EGFRm NSCLC. The patients will be collected across multiple centers in China.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (3)

Fudan University Shanghai Cancer Center

Shanghai, China, 200032, China

Location

Wuhan Tongji Hospital

Wuhan, Hubei, China

Location

Shanghai Jiao Tong University Affiliated Chest Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: July 19, 2019
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CN (3)