Clinical trial · Observational
An Observational Study of Furmonertinib for EGFR Mutation-positive NSCLC Patients With Brain Metastasis
Efficacy and Safety of Furmonertinib for Epidermal Growth Factor Receptor (EGFR) Sensitive Mutation Positive Non-Small Cell Lung Cancer (NSCLC) Patients With Brain Metastasis: a Prospective Observational Study
- 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)
EGFR mutation positive advanced NSCLC patients with CNS metastases were associated with poor prognosis. Furmonertinib showed promising CNS efficacy in doses of 80 mg orally once daily or higher in patients with EGFR T790M mutation positive NSCLC. This study aims to investigate the efficacy and safety of furmonertinib in the treatment of EGFR-sensitive mutation positive NSCLC patients with brain metastasis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CNS Metastases | — | UNRESOLVED | — |
| EGF-R Positive Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Furmonertinib | Drug | Firmonertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Furmonertinib group
- description
- Patients treated with Furmonertinib
- interventionNames
- Drug: Furmonertinib
Primary outcomes (3)
- measure
- Intracranial Objective response rate
- timeFrame
- Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
- description
- Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response, will be assessed up to 2 years.
- measure
- Intracranial Disease Control Rate
- timeFrame
- Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 2 years.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. at least 18 years of age; 2. Histologically or cytologically confirmed metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC); 3. Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.( EGFR L858R or Del 19 with/without T790M ) 4. Imaging (MR/CT) confirmed untreated brain metastases before Furmonertinib initiation; 5. Organ function is compatible with oral Furmonertinib therapy (investigator determination based on real-world practice); 6. Life expectancy ≥12 weeks before Fumonertinib initiation; 7. ECOG PS of 0 to 2; 8. Sign the informed consent form. Exclusion Criteria: 1. Any Third-Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) before Furmonertinib initiation; 2. Known hypersensitivity to Furmonertinib or its excipient components; 3. Simultaneous systemic chemotherapy or WBI; 4. The time from the treatment with any other investigational product or its analogue before Furmonertinib initiation does not exceed 5 half-lives of the drug or 14 days, whichever is longer; 5. Any evidence of severe or uncontrolled systemic diseases; 6. Presence of any disease that may strongly interfere with oral drug absorption; presence of any factor that contributes to QTc prolongation or increased risk of arrhythmia; presence of interstitial pneumonitis.
References
Publications (0)
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