Actively Recruiting
A Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis
Led by Henan Cancer Hospital · Updated on 2025-04-25
146
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
EGFR mutation-positive NSCLC patients have a higher risk of developing brain metastases. The prognosis is poor for patients presenting with brain or leptomeningeal metastases at any stage, particularly those with such metastases at initial diagnosis, who have the worst prognosis. Furmonertinib, as a novel EGFR-TKI, enhances its lipophilicity by incorporating a trifluoroethoxy pyridine group. Preclinical animal studies further confirm that both Furmonertinib (AST2818) and its metabolite (AST5902) exhibit excellent intracranial distribution. This provides strong theoretical support for the effective treatment of lung cancer brain metastasis patients with Furmonertinib. EGFR TKI-based combination therapies, as a strategy to delay disease progression, have consistently been a focal point in medical research. Among these, antiangiogenic agents are increasingly recognized for their synergistic effects when combined with TKIs, jointly inhibiting tumor growth, proliferation, and metastasis.Such combinations have demonstrated clear efficacy and manageable safety profiles. Based on this, the current study aims to explore the efficacy and safety of first-line treatment with 160 mg Furmonertinib combined with anlotinib for advanced NSCLC patients with EGFR-sensitive mutations and brain metastases.
CONDITIONS
Official Title
A Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Histologically or cytologically confirmed advanced NSCLC, staged AJCC TNM 9th edition Stage IV
- Presence of EGFR 19Del or L858R mutations confirmed by a recognized hospital or testing institution
- ECOG performance status score of 0-2 and expected survival of at least 12 weeks
- Brain parenchymal metastases confirmed by CT or MRI, with or without symptoms
- At least one measurable lesion according to RECIST 1.1 criteria
- No prior systemic anticancer therapy for advanced/metastatic NSCLC; prior adjuvant or neoadjuvant therapy allowed if no progression within 6 months
- Adequate organ function including specified blood counts, liver and kidney function
- Male and female patients with reproductive potential must use effective contraception during the study and for 12 months after treatment
You will not qualify if you...
- Diagnosis not confirmed as NSCLC by histology or cytology
- Presence of leptomeningeal metastasis without brain parenchymal metastasis
- Expected need for other systemic anticancer therapies during the trial
- History of malignancies within past 2 years except certain well-controlled skin or cervical/breast cancers
- Significant gastrointestinal diseases affecting drug absorption
- Known or suspected allergies to Furmonertinib, Anlotinib, or their components
- Prior treatment with any EGFR tyrosine kinase inhibitors
- Use of strong CYP3A4 inhibitors or inducers or certain herbal medicines shortly before or during the trial
- History of interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring corticosteroids
- Significant arrhythmias or heart failure with reduced ejection fraction
- Pregnant or breastfeeding women
- Participation in other clinical trials within past 4 weeks
- Severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study compliance
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
F
Fangfang Gao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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