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

November 16, 2025 updated by: Beijing Tiantan Hospital

A Real-World Clinical Retrospective Study of 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Li Xiaoyan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who have received at least one treatment cycle of Firmonertinib are defined as the Full Analysis Set (FAS). Except for specially specified study endpoints (such as DOR which is evaluated only in the population achieving objective response), the primary endpoints, secondary endpoints, and safety endpoints of the study are evaluated in the FAS.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EGFR-mutated NSCLC with brain metastases
Drug: Firmonertinib
Firmonertinib any dose, oral
EGFR-mutated NSCLC with leptomeningeal metastases
Drug: Firmonertinib
Firmonertinib any dose, oral

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Within the study period from January 1, 2020 and May 30, 2025
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
From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025
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
From first dose until death, assessed between January 1, 2020 and May 30, 2025
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
Within the study period from January 1, 2020 and May 30, 2025
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
assessed during the study period from January 1, 2020 and May 30, 2025.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HX-B-2025058

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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