RecruitingNCT01994057

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

Retrospective Study Based on Somatic Mutations, Genetic Polymorphisms and Metabolomics Related to Individual Variations of Drug Effect and Adverse Drug Reaction of EGFR-TKIs,Gefitinib and Erlotinib in Non-small Cell Lung Cancer Treatment.


Sponsor

Sun Yat-sen University

Enrollment

1,000 participants

Start Date

Sep 1, 2012

Study Type

OBSERVATIONAL

Conditions

Summary

For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is looking back at medical records of lung cancer patients who received targeted therapy drugs (gefitinib, erlotinib, or icotinib — all pills that block a protein called EGFR that drives some lung cancers) to understand how long these treatments worked and why some patients responded better than others. **You may be eligible if...** - You have been diagnosed with non-small cell lung cancer and received gefitinib, erlotinib, or icotinib at the participating hospital - Your medical records from this treatment are available and complete enough for review - Your tumor was tested for EGFR mutations (a specific genetic change in the cancer) **You may NOT be eligible if...** - Your medical records are incomplete or unavailable - You did not receive one of the three specified drugs - You received these drugs for a cancer other than non-small cell lung 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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Locations(1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT01994057


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