RecruitingNot ApplicableNCT06102928

A Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced NSCLC With EGFR 21L858R Mutation

A Prospective, Multicenter, Single-arm Clinical Study of the Combination of Anlotinib and Aumolertinib in the First-line Treatment of Advanced Non-small Cell Lung Cancer With EGFR 21L858R Mutation

Sponsor

Kunming Medical University

Enrollment

30 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

Summary

This study is a prospective, multicenter, single arm clinical study. Thirty subjects who will have been diagnosed with locally advanced or metastatic non-small cell lung cancer with EGFR 21L858R mutation detected in lung cancer tissue or peripheral blood will be recruited and treated with anlotinib and aumolertinib. The efficacy will be evaluated according to the Solid Tumor Efficacy Evaluation Standard (RECIST 1.1), and evaluated every 6 to 8 weeks. The survival status and adverse reactions of the subjects will be recorded. The study will be terminated when the subjects experience disease progression or intolerable drug toxicity, or the subjects withdraw their informed consent. The main purpose of the study is to observe the efficacy and safety of the combined treatment regimen in such subjects. The primary endpoint of the study is median progression free survival (mPFS); The secondary study endpoints are objective response rate (ORR), disease control rate (DCR), median overall survival time (mOS), and safety.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two targeted drugs — anlotinib and aumolertinib — as a first-ever treatment for adults with advanced lung cancer (non-small cell lung cancer) that has spread and cannot be surgically removed, specifically in people whose tumors carry a gene change called EGFR L858R. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with advanced or metastatic non-small cell lung cancer (stage IIIB, IIIC, or IV) - Your tumor has a specific gene mutation called EGFR exon 21 L858R - You have never received chemotherapy, radiation, or targeted/immunotherapy for this cancer before - You are well enough to carry out daily activities (ECOG score 0–3) - Your blood counts, liver, and kidney are functioning adequately **You may NOT be eligible if...** - Your blood pressure is not well controlled (above 150/100 mmHg) - You have had a stroke, blood clot, or pulmonary embolism in the past 6 months - You have trouble swallowing, chronic diarrhea, or intestinal problems that affect oral medication - You have brain metastases with symptoms - You have serious heart conditions (e.g., heart attack, heart failure) in the past 6 months - You have severe liver disease or active hepatitis - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCombined therapy of anlotinib and aumolertinib

Participants were treated with anlotinib and aumolertinib.Aumolertinib mesylate tablets are administered 110 mg orally once a day,and anlotinib hydrochloride capsules were given 12 mg once a day, taken for 2 weeks and then discontinued for 1 week, with a treatment cycle every 21 days. If grade 3 or above treatment-related toxicity occurs, anlotinib can be reduced to 10 mg or 8 mg once daily.

Locations(1)

First Affiliated Hospital of Kunming University

Kunming, Yunnan, China

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NCT06102928

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