EGFR Positive Non-small Cell Lung CancerNCT07239102
Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis
An observational study of EGFR Positive Non-small Cell Lung Cancer and Central Nervous System Metastasis, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Positive Non-small Cell Lung Cancer, Central Nervous System Metastasis, Leptomeningeal Metastasis
- What is being tested?
- Firmonertinib
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who cannot provide follow-up data for at least one cycle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- EGFR Positive Non-small Cell Lung Cancer, Central Nervous System Metastasis, Leptomeningeal Metastasis
- Being tested
- Firmonertinib
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FirmonertinibDrug
Firmonertinib any dose, oral
| Study group | Role | What they receive |
|---|---|---|
| EGFR-mutated NSCLC with brain metastases | Not described Receives: Drug: Firmonertinib | |
| EGFR-mutated NSCLC with leptomeningeal metastases | Not described Receives: Drug: Firmonertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
iPFS
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
Measured: From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025
Secondary outcomes (5)
iDCR
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
Measured: Within the study period from January 1, 2020 and May 30, 2025
PFS
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
Measured: From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025
OS
measured from the date of first-line treatment initiation to the date of documented death
Measured: From first dose until death, assessed between January 1, 2020 and May 30, 2025
DOR
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
Measured: Within the study period from January 1, 2020 and May 30, 2025
TTR
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
Measured: assessed during the study period from January 1, 2020 and May 30, 2025.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Jan 2020
- Primary completion1 May 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239102
- Sponsor's protocol ID
- HX-B-2025058
- Status last verified
- May 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Clinical Retrospective Study of Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis
- ClinicalTrials.gov ID
- NCT07239102
- Acronym / sponsor ID
- HX-B-2025058
- Conditions
- EGFR Positive Non-small Cell Lung Cancer, Central Nervous System Metastasis, Leptomeningeal Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGFR-mutated NSCLC with brain metastases | – | Drug: Firmonertinib |
| EGFR-mutated NSCLC with leptomeningeal metastases | – | Drug: Firmonertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who cannot provide follow-up data for at least one cycle.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FirmonertinibFirmonertinib any dose, oral | Drug | EGFR-mutated NSCLC with brain metastases, EGFR-mutated NSCLC with leptomeningeal metastases |
Primary outcome
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
5 secondary outcomes
iDCR
Time frame: 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
OS
Time frame: 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
TTR
Time frame: assessed during the study period from January 1, 2020 and May 30, 2025.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EGFR Positive Non-small Cell Lung Cancer and Central Nervous System Metastasis, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
iPFS (time frame: From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.