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Completed

NCT Number: NCT07239102

Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis

This is a clinical retrospective study that will collect and analyze clinical data from all patients treated with fumeitinib mesylate in the Oncology Department of Tiantan Hospital between January 1, 2020 and May 31, 2025. The data collection will include general demographic characteristics (gender, age, family history, smoking history, etc.), clinicopathological features, NGS test reports, fumeitinib initiation time and dosage, concomitant medications, local treatments (surgery, radiotherapy, etc.), and baseline and follow-up imaging examinations related to efficacy and safety. The study will conduct: 1) clinical data analysis; and 2) exploration of resistance-related clinical characteristics and influencing factors.

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Key information

Conditions

EGFR Positive Non-small Cell Lung Cancer Central Nervous System Metastasis Central Nervous System Neoplasms Leptomeningeal Metastasis Meningeal Carcinomatosis Meningeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Li Xiaoyan

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed stage IIIb-IVb NSCLC or postoperative recurrent NSCLC;
  • Positive EGFR test result, which can be determined by methods such as RT-PCR/FISH/IHC/NGS from hospital laboratories or testing institutions;
  • Patients aged ≥18 years;
  • Patients have clinically received Firmonertinib treatment, with recorded objective efficacy evaluation and adverse reactions;
  • Sign the Beijing Tiantan Hospital broad informed consent form.

Exclusion criteria

  • Patients who cannot provide follow-up data for at least one cycle.

Treatment and study plan

Firmonertinib

Drug

Firmonertinib any dose, oral

Primary outcomes

  1. iPFS

    Time frame: From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025

    According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and the Response Assessment in Neuro-Oncology (RANO) criteria, the intracranial progression-free survival (iPFS) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and EGFR mutation-positive status will be evaluated separately for different cohorts

Secondary outcomes

  1. iDCR

    Time frame: Within the study period from January 1, 2020 and May 30, 2025

    For different cohorts, evaluate the intracranial objective response rate (iORR) and disease control rate (iDCR) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) positive for EGFR mutations and presenting with central nervous system metastases

  2. PFS

    Time frame: From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025

    According to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) the progression-free survival (iPFS) of Firmonertinib in subjects with advanced non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases and EGFR mutation-positive status will be evaluated separately for different cohorts

  3. OS

    Time frame: From first dose until death, assessed between January 1, 2020 and May 30, 2025

    measured from the date of first-line treatment initiation to the date of documented death

  4. DOR

    Time frame: Within the study period from January 1, 2020 and May 30, 2025

    defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria, assessed at the first radiologic evaluation following initiation of treatment

  5. TTR

    Time frame: assessed during the study period from January 1, 2020 and May 30, 2025.

    Defined as the time from the initiation of treatment to the date of first documented objective response (CR or PR) according to RECIST 1.1 criteria

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

A Real-World Clinical Retrospective Study of Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2025
Registry last updated
Nov 20, 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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