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NCT05598528

Exploring 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

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

210

Start Date

2021-09-28

Completion Date

2026-12-31

Last Updated

2024-12-02

Healthy Volunteers

No

Interventions

OTHER

Genomic profiles detection

The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing

OTHER

circulating tumor DNA detection

The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing

Locations (1)

Department of Oncology, The Second Xiangya Hospital, Central South University

Changsha, Hunan, China