Clinical trial Recruiting at 1 site Observational Ages 18 to 85

Evaluating EGFR-TKI treatments in lung cancer patients

Official title: 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.

Run by Sun Yat-sen University · NCT01994057 · Data updated 2026-11-12

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.

More Non-small Cell Lung Cancer (NSCLC) trials

Quick facts

Study typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment1000 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionschemotherapy, crizotinib, gefitinib, erlotinib
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedSeptember 2012
Main results expectedOctober 2025
Study endsDecember 2026
Registry record updatedApril 12, 2023
Trial IDNCT01994057 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with uncontrolled systemic diseases or clinically active interstitial lung diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown promise in using genetic profiling to tailor cancer treatments, indicating that this approach has potential for success.

Who can join: the full rules

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 it's running

  • Cancer Center, Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.