Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Metastasis | — | UNRESOLVED | — |
| EGFR Positive Non-small Cell Lung Cancer | — | UNRESOLVED | — |
| Leptomeningeal Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Firmonertinib | Drug | Firmonertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- EGFR-mutated NSCLC with brain metastases
- interventionNames
- Drug: Firmonertinib
- label
- EGFR-mutated NSCLC with leptomeningeal metastases
- interventionNames
- Drug: Firmonertinib
Primary outcomes (1)
- measure
- iPFS
- timeFrame
- From first dose until the event of interest, assessed between January 1, 2020 and May 30, 2025
- description
- 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
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available