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A Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis

NCT06945705 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-04-25

No results posted yet for this study

Summary

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

Interventions

DRUG

furmonertinib combined with anlotinib

furmonertinib: 160 mg po qd Anlotinib: 8 mg per day, orally administered.The treatment cycle is every 3 weeks, with each cycle lasting 21 days. Anlotinib are taken on Days 1-14 of each cycle.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2027-09-02
Completion
2028-10-02

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06945705 on ClinicalTrials.gov