Clinical trial NCT06926803: A Clinical Study of Furmonertinib in the Treatment of EGFR-Mutated NSCLC With Leptomeningeal Metastases
Official title: A Clinical Study of Furmonertinib in the Treatment of EGFR-Mutated NSCLC With Leptomeningeal Metastases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lung Cancer (NSCLC)
Leptomeningeal Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with EGFR-mutated non-small cell lung cancer (NSCLC) and leptomeningeal metastasis who received furmonertinib therapy between \*\*March 3, 2021, and December 31, 2024\*\*, with a treatment duration of ≥1 month.

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.


Eligibility criteria: 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.

Primary outcomes:
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））
Secondary outcomes:
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)）
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)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
References: