Status:
ACTIVE_NOT_RECRUITING
A Clinical Study of Furmonertinib in the Treatment of EGFR-Mutated NSCLC With Leptomeningeal Metastases
Lead Sponsor:
Qiming Wang
Conditions:
Lung Cancer (NSCLC)
Leptomeningeal Cancer
Eligibility:
All Genders
18+ years
Brief 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 th...
Eligibility Criteria
Inclusion
- 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;
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06926803
Start Date
March 1 2025
End Date
August 1 2025
Last Update
April 15 2025
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008