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ID01994057

Study of Genetic Factors Affecting Response and Side Effects of EGFR-TKI Drugs Gefitinib, Erlotinib, and Osimertinib in Non-Small Cell Lung Cancer Patients

Led by Sun Yat-sen University · Updated on 2023-04-12

1000

Participants Needed

1

Research Sites

60 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying advanced non-small cell lung cancer NSCLC patients to understand how individual genetic differences affect the response and side effects of treatments called EGFR-TKIs, including gefitinib, erlotinib, and osimertinib. This observational study aims to find better ways to detect sensitive mutations in plasma and explore the relationship between various genetic mutations, drug concentrations, and treatment effects. The research also includes lab studies to explain these clinical observations. The study evaluates patients who have received EGFR-TKIs and categorizes them as sensitive or resistant based on their response after one and three months of treatment. Sensitive patients show complete or partial response or stable disease, while resistant patients show progressive disease. Genetic variations in ADME-associated genes and somatic mutations like EGFR and K-RAS are analyzed to see how they relate to drug effect and adverse reactions. Participants health is assessed through clinical and laboratory evaluations, including performance status and organ function tests. Researchers measure progression-free survival and track objective responses and adverse events at one and three months. The study includes patients aged 18 to 85 with confirmed NSCLC and follows them retrospectively to better understand the influence of genetic factors on treatment outcomes.

CONDITIONS

Brief Title

A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment

Research Team

S

shaoxing guan, PHD

M

Min Huang, Professor

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