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

Beijing Tiantan Hospital300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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

Time frame: 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

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

measured from the date of first-line treatment initiation to the date of documented death

Time frame: 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