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NCT Number: NCT07491211

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

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.

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Key information

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer) Brain Diseases Brain Metastases From Non-small Cell Lung Cancer (NSCLC) Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Osimertinib Respiratory Tract Diseases Respiratory Tract Neoplasms Stereotactic Radiation Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center, Shanghai, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osimertinib

Drug

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

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.

Primary outcomes

  1. Real-world Progression-Free Survival (rwPFS)

    Time frame: 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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: 5 years

    The time from index date until death due to any cause. Any patient not known to have died at the time of analysis will have OS censored at the date they were last known to be alive.

  2. rwPFS2

    Time frame: 5 years

    The time from index date to the earliest of the progression event (following the initial investigator-assessed progression) after first subsequent therapy, or death. Any patient not known to have progressed on first subsequent therapy or died at the time of analysis will have rwPFS2 censored at the date of last assessment showing no progression.

  3. TTNT (Time to Next Treatment or Death)

    Time frame: 5 years

    The time from index date to the start date of the first subsequent treatment or death, whichever occurs first. Any patient not known to have a subsequent treatment or died at the time of analysis will have TTNT cencored at the date of last follow-up without a record of new treatment.

  4. TTD (Time to Treatment Discontinuation or Death)

    Time frame: 5 years

    The time from first-line Osimertinib iniation to discontinuation due to any reason or death, whichever occurs first. Any patient not known to have discontinued first-line Osimertinib or died at the time of analysis will have TTD censored based on the last recorded date on which the patient was known to be on treatment..

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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