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

Last updated: April 10, 2023
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01994057
2012ZX09506001-004 (2)
(2)
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria: The main patient entry criteria included: age≥ 18 years ; histologically and cytologicallyproved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate

Exclusion

hematological , renal, and hepatic functions. Exclusion Criteria: uncontrolled systemic disease ,any evidence of clinically active interstitial lungdiseases, and other chemotherapy at the time of inclusion. The protocol was approved by theEthical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informedconsent was obtained form each patient.

Study Design

Total Participants: 1000
Study Start date:
September 01, 2012
Estimated Completion Date:
December 31, 2026

Study 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

Connect with a study center

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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