Evaluating EGFR-TKI treatments in lung cancer patients
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.
This study is testing how well different EGFR-TKI treatments work for people with advanced lung cancer and looking at how genetic factors and drug levels affect their results.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, crizotinib, gefitinib, erlotinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT01994057 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with advanced non-small cell lung cancer (NSCLC) and aims to analyze the effectiveness of EGFR-TKI treatments such as gefitinib, erlotinib, and osimertinib. It seeks to establish a sensitive method for detecting mutations in plasma and to explore the relationship between somatic and germline mutations, drug concentration, and treatment outcomes. The study will also investigate how pharmacokinetic and pharmacodynamic factors influence drug efficacy and adverse reactions. In vivo and in vitro research will complement the clinical findings to provide a comprehensive understanding of these phenomena.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with histologically confirmed NSCLC and an ECOG performance status of 2 or less.
Not a fit: Patients with uncontrolled systemic diseases or clinically active interstitial lung diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for NSCLC patients based on their genetic profiles.
How similar studies have performed: Previous studies have shown promise in using genetic profiling to tailor cancer treatments, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Cancer Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: shaoxing guan, PHD
- Email: guanshx6@mail.sysu.edu.cn
- Phone: +86 13129351756
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.