Leptomeningeal Cancer, Lung Cancer (NSCLC)
Conditions
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 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.
Interventions
None listed
Sponsors
Qiming Wang
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥18 years, male or female; 2. Histologically or cytologically confirmed diagnosis of \*\*non-small cell lung cancer (NSCLC); 3. EGFR mutation-positive(classic or non-classic mutations) confirmed by genetic testing; 4. 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; 5. 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
1. History of other malignancies during NSCLC treatment or prior to diagnosis, except those effectively controlled (e.g., complete remission ≥5 years); 2. Severe gastrointestinal disorders affecting drug administration or absorption, including but not limited to peptic ulcer disease, inflammatory bowel disease, or malabsorption syndromes; 3. 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; 4. Incomplete medical records or follow-up data; 5. Pregnancy or lactation; 6. Other severe acute/chronic medical conditions, psychiatric disorders, or laboratory abnormalities that, in the investigator's opinion, may confound the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | 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）） | overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TTF | Defined as the interval from the first administration of furmonertinib after the diagnosis of leptomeningeal metastasis to the permanent discontinuation of furmonertinib therapy due to disease progression, toxicity, or any other reason（up to 12 months)） | Time to Treatment Failure |
| ORR-LM | The proportion of subjects achieving complete response (CR) or partial response (PR) in leptomeningeal lesions, observed from the first administration of furmonertinib after leptomeningeal metastasis diagnosis until disease progression(up to 12 months) | Objective Response Rate for Leptomeningeal Metastasis |
Countries
China
Outcome results
None listed