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Real-World data on firmonertinib for lung cancer that spread to the brain

NCT ID NCT07239102

Knowledge-focused Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked back at medical records of 300 people with EGFR-positive non-small cell lung cancer that had spread to the brain or spinal cord. All patients were treated with the drug firmonertinib. Researchers analyzed how long the drug controlled brain tumors and explored why some patients stopped responding. The goal is to better understand real-world effectiveness and resistance patterns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Firmonertinib (oral drug)
What this could lead to
If successful, this analysis could help identify which patients benefit most from firmonertinib and how resistance develops, guiding future treatment strategies.
What could go wrong
This is a retrospective review of past medical records, not a controlled trial. Results may be influenced by incomplete data or patient selection bias.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

300 people

The number who actually took part.

Started

Jan 2020

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Meningeal Carcinomatosis metastatic malignant neoplasm in the brain neoplastic meningitis non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Central nervous system metastasis EGFR positive non-small cell lung cancer Leptomeningeal metastasis

Contacts and locations

Locations

  • Li Xiaoyan

    Beijing, Beijing Municipality, China

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