A Clinical Study of Furmonertinib in the Treatment of EGFR-Mutated NSCLC With Leptomeningeal Metastases

NCT06926803 | Active Not Recruiting

• 1 other identifier: 2025-019
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer (NSCLC); Leptomeningeal Cancer

Outcome Measures

Primary Outcomes (1)

• OS

  overall survival

  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 (2)

• 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)）

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qiming Wang: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: April 15, 2025
• Study Start: March 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)