Actively Recruiting
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
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of combining Furmonertinib with Anlotinib as a first treatment option for patients with advanced non-small cell lung cancer (NSCLC) who have EGFR-sensitive mutations and brain metastases. Patients with EGFR mutation-positive NSCLC have an increased risk of brain metastases, which often lead to a poor prognosis. Furmonertinib is a new EGFR tyrosine kinase inhibitor (TKI) with enhanced brain penetration, supported by preclinical studies, and combining it with antiangiogenic agents like Anlotinib may improve treatment outcomes by jointly inhibiting tumor growth and spread. Participants will receive Furmonertinib at a dose of 160 mg once daily and Anlotinib at 8 mg daily taken orally for 14 days in each 21-day treatment cycle. This study is a single-arm, multi-center, phase 2 trial that includes an initial safety phase lasting up to 6 months, followed by a formal research phase lasting up to 42 months to assess treatment efficacy and safety over time. During the study, participants will undergo regular assessments including brain imaging with CT or MRI to confirm brain metastases and measurable tumor lesions. Researchers will monitor safety, progression-free survival, response rates, disease control, and duration of response, including specific evaluations of central nervous system effectiveness. The study will also track participants' overall health and organ function, with safety evaluations continuing throughout the treatment period up to 42 months.
CONDITIONS
Brief 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...
- Age 18 years or older
- Confirmed advanced NSCLC at stage IV
- Presence of EGFR 19Del or L858R mutations
- Brain metastases confirmed by CT or MRI
- ECOG performance status score of 0-2
- Expected survival of at least 12 weeks
- At least one measurable lesion by RECIST 1.1 criteria
- No prior systemic therapy for advanced/metastatic NSCLC
- Adequate organ function as specified
- Use of effective contraception during the study and for 12 months after treatment if of reproductive potential
You will not qualify if you...
- Diagnosis not confirmed as NSCLC
- Presence of leptomeningeal metastasis without brain parenchymal metastasis
- Need for other systemic anticancer therapies during the trial
- History of malignancies within past 2 years except certain skin or breast cancers
- Significant gastrointestinal diseases affecting drug absorption
- Known allergies to Furmonertinib, Anlotinib, or their components
- Previous treatment with any EGFR-TKI
- Recent or expected use of strong CYP3A4 inhibitors or inducers or antitumor Chinese herbal medicines
- History of interstitial lung disease or radiation pneumonitis requiring corticosteroids
- Significant arrhythmias or heart failure
- Pregnant or breastfeeding women
- Participation in other clinical trials within past 4 weeks
- Severe medical or psychiatric conditions that increase risk or interfere with study completion or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 42 months
Participants receive furmonertinib combined with anlotinib as first-line treatment for advanced NSCLC with EGFR-sensitive mutations and brain metastasis. Treatment cycles last 3 weeks each, with anlotinib taken on Days 1-14 of each cycle.
Visits every 3 weeks corresponding to each treatment cycle
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
F
Fangfang Gao
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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