A Retrospective Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in Non-small Cell Lung Cancer(NSCLC)Treatment
Non-small Cell Lung Cancer (NSCLC); - EGFR-TKI Resistant Mutation; - EGFR-TKI Sensitizing Mutation; - Germline Mutations
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Non-small cell lung cancer (NSCLC);, EGFR-TKI;, Pharmacogenetics;, Precision medicine, somatic mutations ,germline mutations;
Study Type
Study Phase
Study Design
Observational Model: Case-Only, Time Perspective: Retrospective
Overall Status
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.
Detailed 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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Shuang Xin, PHD - +86 13580479553 - xshuang@mail2.sysu.edu.cn
Start Date
September 2013
Completion Date
September 2016
Sun Yat-sen University
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page