Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 1:57 AM
Study NCT ID:
NCT06945705
Status:
RECRUITING
Last Update Posted:
2025-04-25
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
Official Title:
A Prospective, Single-arm, Multi-center Clinical Trial of Furmonertinib Combined With Anlotinib as First-line Treatment for Advanced NSCLC With EGFR-sensitive Mutations and Brain Metastasis.
Status:
RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: