A Clinical Study of Furmonertinib in the Treatment of EGFR-Mutated NSCLC With Leptomeningeal Meta… (NCT06926803) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Clinical Study of Furmonertinib in the Treatment of EGFR-Mutated NSCLC With Leptomeningeal Metastases
China500 participantsStarted 2025-03-01
Plain-language summary
This study adopts a retrospective design. Patients enrolled will include those who received furmonertinib (treatment duration ≥1 month) between March 3, 2021, and December 31, 2024, with concurrent therapies permitted (e.g., radiotherapy, intrathecal chemotherapy, surgical interventions such as ventriculoperitoneal shunting). A retrospective analysis will be conducted to investigate the efficacy and safety of furmonertinib-based therapy (with or without other treatments) in EGFR-mutated NSCLC patients with leptomeningeal metastasis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients aged ≥18 years, male or female;
✓. Histologically or cytologically confirmed diagnosis of \*\*non-small cell lung cancer (NSCLC);
✓. " EGFR mutation-positive"(classic or non-classic mutations) confirmed by genetic testing;
✓. "Leptomeningeal metastasis" definitively diagnosed by investigators based on "EANO-ESMO diagnostic criteria", involving comprehensive clinical assessment including symptom evaluation, imaging evaluation (MRI/CT), and/or cerebrospinal fluid (CSF) cytology;
✓. Received furmonertinib (treatment duration ≥1 month) between "March 3, 2021, and December 31, 2024", with concurrent therapies permitted (e.g., radiotherapy, intrathecal chemotherapy, surgical interventions such as ventriculoperitoneal shunting).
Exclusion criteria
✕. History of other malignancies during NSCLC treatment or prior to diagnosis, except those effectively controlled (e.g., complete remission ≥5 years);
✕. Severe gastrointestinal disorders affecting drug administration or absorption, including but not limited to peptic ulcer disease, inflammatory bowel disease, or malabsorption syndromes;
What they're measuring
1
OS
Timeframe: The time interval from the first administration of furmonertinib after the diagnosis of leptomeningeal metastasis to the date of death from any cause（up to 60 months））
✕. Evidence of uncontrolled systemic diseases (e.g., uncontrolled hypertension \[BP \>140/90 mmHg despite treatment\], diabetes mellitus \[HbA1c \>8%\], arrhythmias, heart failure \[NYHA class III/IV\], active bleeding, active infections requiring IV antibiotics, or interstitial pneumonia requiring corticosteroid therapy), which in the investigator's judgment may directly compromise patient prognosis;
✕. Incomplete medical records or follow-up data;
✕. Pregnancy or lactation;
✕. Other severe acute/chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the investigator's opinion, may confound the interpretation of study results.