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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

NCT04978753 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-07-27

No results posted yet for this study

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

Interventions

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;

Sponsors & Collaborators

  • Li-kun Chen

    lead OTHER

Principal Investigators

  • Likun Chen · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-05-30
Completion
2023-12-30

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT04978753 on ClinicalTrials.gov