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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01994057
Enrollment
1000
Registered
2013-11-25
Start date
2012-09-30
Completion date
2026-12-31
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Non-small cell lung cancer (NSCLC);, EGFR-TKI;, Pharmacogenetics;, Precision medicine, somatic mutations ,germline mutations;

Brief 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.

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

Interventions

None listed

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Progression free survivalThe length of time from either the date of diagnosis to that patients diagnosed with the disease are still aliveExcluding clinical deterioration without evidence of objective progression according to the Response Evaluation Criteria In Solid Tumors (RECIST), or death from any cause.

Secondary

MeasureTime frameDescription
Number of patients with objective response and adverse eventsone month, three monthObjective responses (complete response plus partial response) and disease control (objective response plus stable disease ≥6 weeks) were established according to RECIST.And adverse events was established according to NCI-CTC .

Other

MeasureTime frameDescription
Number of patients with ADRone month, three monthSuch as rash

Countries

China

Contacts

Primary Contactshaoxing guan, PHD
guanshx6@mail.sysu.edu.cn+86 13129351756
Backup ContactMin Huang, Professor
huangmin@mail.sysu.edu.cn+86 020 87331409-101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026