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

Capital Medical University

Status: Completed

Conditions: Leptomeningeal Metastasis; EGFR Positive Non-small Cell Lung Cancer; Central Nervous System Metastasis

Treatments: Drug: Firmonertinib

Study type: Observational

Funder types: Other

Identifiers

NCT07239102

HX-B-2025058

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

EGFR-mutated NSCLC with brain metastases

Treatment:

Drug: Firmonertinib

EGFR-mutated NSCLC with leptomeningeal metastases

Treatment:

Drug: Firmonertinib