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

October 22, 2023 updated by: Yuqi Cheng, Kunming Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jianqing Zhang, Ph.D
  • Phone Number: (86)18988272502
  • Email: ydyyzjq@163.com

Study Contact Backup

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • First Affiliated Hospital of Kunming University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1) The patient voluntarily participated in this study and signed an informed consent form; 2) Age>18 years old, both male and female; 3) Advanced stage unresectable or metastatic NSCLC (stage IIIB, IIIC, or IV) confirmed by histology or cytology, with the presence of EGFR 21 exon L858R mutation in the driving gene; 4) According to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), at least one measurable lesion is used as the target lesion; 5) The Eastern Cancer Collaborative Group's Physical State Score (ECOG PS) is 0 to 3 points; 6) Expected survival time is more than 3 months; 7) Newly treated patients who have not received systematic anti-tumor treatment in the past, including radiotherapy and chemotherapy, targeted and immunotherapy; 8) The main organ function meets the following standards within 7 days before treatment:(1) Blood routine examination standard (without blood transfusion within 14 days): ① Hemoglobin (HB) ≥ 90g/L; ② Absolute value of neutrophils (ANC) ≥ 1.5 × 109/L; ③ Platelet (PLT) ≥ 80 × 109/L.(2) Biochemical examination should meet the following standards: ① Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); ② Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 2.5ULN, if accompanied by liver metastasis, ALT and AST ≤ 5ULN; ③ Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance rate (CCr) ≥ 60ml/min.

Exclusion Criteria:

  1. Mixed NSCLC containing other pathological components;
  2. Poor blood pressure control (systolic blood pressure ≥ 150mmHg, diastolic blood pressure ≥ 100mmHg);
  3. Imaging shows that the tumor invades important blood vessels, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
  4. Have experienced arteriovenous thrombosis events within 6 months, such as cerebrovascular accidents, deep venous thrombosis, and pulmonary embolism in patients;
  5. Patients with combined factors that affect oral medication, such as difficulty swallowing, gastrointestinal resection, chronic diarrhea, or intestinal obstruction;
  6. Patients with symptomatic brain metastases;
  7. Patients with severe and/or uncontrollable diseases, such as myocardial infarction, unstable angina, congestive heart failure, and severe uncontrollable arrhythmias within 6 months prior to enrollment;
  8. Active or uncontrolled severe infections;
  9. Severe liver dysfunction, cirrhosis, acute or chronic active hepatitis;
  10. The urine routine results showed that the urine protein level was ≥++, and the 24-hour urine protein quantitative detection result was>1.0g;
  11. Active pulmonary tuberculosis;
  12. Pregnant or lactating women;
  13. According to the judgement of the researchers, the subjects may have other factors that may cause the study to be terminated midway, such as other serious illnesses (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, and accompanying family and social factors, which may affect the safety of the subjects or the collection of data and samples.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Participants who met the study protocol were treated with anlotinib and aumolertinib.Aumolertinib mesylate tablets are administered 110 mg orally once a day until disease progression or unacceptable toxicity. 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 until disease progression or unacceptable toxicity occurs.
Drug: Combined 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
median Progressive Free Survival (mPFS)
Time Frame: up to two years
The time from the subject's initiation of treatment with anlotinib and aumolertinib to the occurrence of disease progression.
up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate(ORR)
Time Frame: 6 to 8 weeks after the subjects used the investigational drugs
The percentage of subjects who achieved complete remission or partial remission after 6 to 8 weeks of treatment with anlotinib and aumolertinib.
6 to 8 weeks after the subjects used the investigational drugs
Disease control rate (DCR)
Time Frame: 6 to 8 weeks after the subjects used the investigational drugs
The percentage of subjects whose tumors shrink or remain stable after 6 to 8 weeks of treatment with anlotinib and aumolertinib.
6 to 8 weeks after the subjects used the investigational drugs
median Overall survival(mOS)
Time Frame: up to three years
Median time from subjects' enrollment to death for any reasons. For subjects who are lost to follow-up before death, the last follow-up time will be calculated as the time of death.
up to three years
Safety of combined therapy
Time Frame: up to two years
Number of participants who had drug-related adverse reactions during the trial and the degree of adverse reactions.
up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kunming Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2023

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

October 22, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROC202316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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