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

NCT ID: NCT07239102

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-10-01

Brief 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. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

EGFR-mutated NSCLC with brain metastases

Firmonertinib

Intervention Type: DRUG

Firmonertinib any dose, oral

EGFR-mutated NSCLC with leptomeningeal metastases

Firmonertinib

Intervention Type: DRUG

Firmonertinib any dose, oral

Interventions

Firmonertinib

Firmonertinib any dose, oral

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Li Xiaoyan

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HX-B-2025058

Identifier Type: -

Identifier Source: org_study_id