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

Sponsor
Henan Cancer Hospital
Study ID
NCT06945705
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • furmonertinib combined with anlotinib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 2, 2025
Status verified
Jan 2025
Primary completion
Sep 2, 2027
Completion
Oct 2, 2028

Study Design

Enrollment
146 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: furmonertinib combined with anlotinib
    furmonertinib combined with anlotinib

Primary Outcome Measure

Safety（Phase One: Safe Introduction Phase） [ Time Frame: Up to 6 months ]

Central Contacts

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