RecruitingNCT05598528

Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

Sponsor

Second Xiangya Hospital of Central South University

Enrollment

210 participants

Start Date

Sep 28, 2021

Study Type

OBSERVATIONAL

Conditions

Lung Cancer (Non-Small Cell)Circulating Tumor DNA EGFR-TKI Resistant Mutation EGFR Gene Mutation Primary Resistance

Summary

Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients. However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term. This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines why some advanced lung cancers stop responding to a type of targeted therapy called third-generation EGFR inhibitors right from the start. Understanding this primary resistance could help doctors develop better treatments for patients with EGFR-positive non-small cell lung cancer (NSCLC). **You may be eligible if...** - You are over 18 years old - You have been diagnosed with NSCLC confirmed by biopsy or cell testing - Your cancer is at an advanced, unresectable stage (Stage IIIB-IV or recurrent after surgery) - Your tumor has a specific gene mutation called EGFR - You have at least one measurable tumor that can be tracked **You may NOT be eligible if...** - Your tumor does not have an EGFR mutation - You have already received EGFR-targeted therapy - You have serious organ problems or another active cancer 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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