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Treatment of EGFR-TKI for Residual Lesions of Multiple Synchronous Ground-glass Opacities

NCT04982900 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2021-10-05

No results posted yet for this study

Summary

This study is a multi-center, prospective, double-blind randomized controlled clinical trial. The purpose is to evaluate the efficacy and safety of EGFR-TKI on residual GGOs after surgery in patients with multiple primary lung cancers with ground glass nodules. This study is expected to prove that compared with placebo in the control group, EGFR-TKI can significantly reduce the residual GGOs lesions in patients with EGFR-positive multiple primary lung cancers with ground-glass opacity, and bring a higher objective response rate (ORR), thus provides new insights for treatment of these patients.

Conditions

  • Multiple Primary Lung Cancers

Interventions

DRUG

furmonertinib

AST2818 is an irreversible and highly selective EGFR inhibitor independently discovered and developed by Allist. It has the potential to become the best-in-class drug in the third-generation EGFR-TKIs. Data from the preclinical studies and the completed clinical studies show that AST2818 has the following advantages: 1) AST2818 has good target selectivity and tissue distribution specificity; 2) The objective response rate of AST2818 for the patients with locally advanced or metastatic NSCLC with EGFR T790M mutation is outstanding, reaching 74.1% in the key registration clinical study; 3) AST2818 has a good safety profile and is well-tolerated; 4) AST2818 and its active metabolites have a superior ability to penetrate the blood-brain barrier, and have a good therapeutic efficacy on brain metastases frequently seen in patients with NSCLC.

DRUG

Placebo

The placebo has the same appearance, weight, and physical and chemical properties as the study drug, and is provided by the researcher to the subjects in control group.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    collaborator OTHER

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • Tang-Du Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Hecheng Li, PhD, MD · Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-08-01
Completion
2022-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04982900 on ClinicalTrials.gov