the Efficacy and Safety of Anlotinib Combined With Almonertinib in the First-line Treatment of Patients With Brain Metastases From EGFR Mutation-positive Non-small Cell Lung Cancer

Summary

Subject population：Patients with brain metastases from EGFR mutation-positive non-small cell lung cancer who have not received systemic treatment. Experimental design: Single-center, single-arm phase II clinical trial. Purpose: Efficacy and safety of Anlotinib combined with Almonertinib in the treatment of patients with brain metastases from EGFR mutation-positive non-small cell lung cancer. treatment plan: 1). Anlotinib: 12mg/time (BSA≥1.6 m2) or 10mg/time (BSA\<1.6 m2), once a day orally, taking two weeks and stopping for one week; 2). Almonertinib: 110mg, orally once a day; primary endpoint: Intracranial progression-free survival (iPFS); secondary endpoint: Objective intracranial response rate (iORR=iCR+iPR), intracranial disease control rate (iDCR=iCR+iPR+i SD), overall progression-free survival (PFS), overall survival (OS), quality of life score.

Timeline

Start

2021-05-01

Primary completion

2022-05-30

Completion

2023-12-30

Publications

• Chen J, Pan Y, Li M, Yu H, Zhang B, Yu M, Hou X, Chen L. Efficacy and safety with aumolertinib plus anlotinib for untreated EGFR-mutant NSCLC with brain metastases. NPJ Precis Oncol. 2025 Dec 1;10(1):2. doi: 10.1038/s41698-025-01191-2.

Drugs

Indications