Clinical trial · Observational
A Clinical Study of Furmonertinib in the Treatment of EGFR-Mutated NSCLC With Leptomeningeal Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leptomeningeal Cancer | Malignant Leptomeningeal Neoplasm | ALIAS | 0.90 |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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))
- description
- overall survival
Secondary outcomes (2)
- measure
- TTF
- timeFrame
- 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))
- description
- Time to Treatment Failure
- measure
- ORR-LM
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available