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

NCT07239102 | Completed

• 1 other identifier: HX-B-2025058
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• iDCR

  Within the study period from January 1, 2020 and May 30, 2025

• PFS

  From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025

• OS

  From first dose until death, assessed between January 1, 2020 and May 30, 2025

• DOR

  Within the study period from January 1, 2020 and May 30, 2025

• TTR

  assessed during the study period from January 1, 2020 and May 30, 2025.

Study Arms (2)

EGFR-mutated NSCLC with brain metastases

Drug: Firmonertinib

EGFR-mutated NSCLC with leptomeningeal metastases

Drug: Firmonertinib

Interventions

Firmonertinib DRUG

Firmonertinib any dose, oral

EGFR-mutated NSCLC with brain metastases; EGFR-mutated NSCLC with leptomeningeal metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Patients who cannot provide follow-up data for at least one cycle.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Li Xiaoyan

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Meningeal Carcinomatosis

Condition Hierarchy (Ancestors)

Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: January 1, 2020
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-05

Locations

CN (1)