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NCT Number: NCT06926803

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. OS

    Time frame: 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 outcomes

  1. TTF

    Time frame: 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

  2. ORR-LM

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Qiming Wang

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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