An observational study in NSCLC (Advanced Non-small Cell Lung Cancer), Brain Metastases From Non-small Cell Lung Cancer (NSCLC) and Osimertinib, sponsored by Fudan University. Active, not recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Fudan University · Observational
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.
6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.
This study's planned enrollment of 300 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Fudan University is the lead sponsor of 1,271 studies on the registry; 624 are open to participants now.
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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.
Exclusion Criteria:
Patients receiving first-line osimertinib combined with early intracranial stereotactic radiotherapy
Drug: Osimertinib · Radiation: intracranial stereotactic radiotherapy
Eligible patients received first-line osimertinib monotherapy for systemic treatment.
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.
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.
Time frame: 5 years
Overall Survival (OS)
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.
Time frame: 5 years
rwPFS2
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.
Time frame: 5 years
TTNT (Time to Next Treatment or Death)
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.
Time frame: 5 years
TTD (Time to Treatment Discontinuation or Death)
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..
Time frame: 5 years
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Fudan University