NCT04978753

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

Phase II Clinical Study of 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-----a Prospective, Single-arm Exploratory Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Li-kun Chen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Anlotinib	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;

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-05-30
• Completion: 2023-12-30
• First posted: 2021-07-27
• Last updated: 2021-07-27

Locations

1 site across 1 country: China