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

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

Recruiting
18-85 years
All
Phase N/A

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Overview

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.

Description

The ADME-associated SNPs included are CYP3A4,CYP3A4,CYP1A1,CYP2D6, ABCB1,ABCG2 and so on .The somatic mutations included are EGFR ,K-RAS ,ALK and so on

Eligibility

Inclusion Criteria:

        The main patient entry criteria included: age≥ 18 years ; histologically and cytologically
        proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate
        hematological , renal, and hepatic functions. Exclusion Criteria:
        uncontrolled systemic disease ,any evidence of clinically active interstitial lung
        diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the
        Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed
        consent was obtained form each patient.

Study details
    Non-small Cell Lung Cancer (NSCLC)
    EGFR-TKI Resistant Mutation
    EGFR-TKI Sensitizing Mutation
    Germline Mutations
    Somatic Mutation

NCT01994057

Sun Yat-sen University

28 January 2024

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