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

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: Completed
• Conditions: Leptomeningeal Metastasis; EGFR Positive Non-small Cell Lung Cancer; Central Nervous System Metastasis
• Intervention / Treatment: Drug: Firmonertinib

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	assessed during the study period from January 1, 2020 and May 30, 2025.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Meningeal Neoplasms; Central Nervous System Neoplasms; Meningeal Carcinomatosis
• Other Study ID 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