Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC
|ClinicalTrials.gov Identifier: NCT01775943|
Recruitment Status : Unknown
Verified December 2013 by Young Joo Min, Ulsan University Hospital.
Recruitment status was: Enrolling by invitation
First Posted : January 25, 2013
Last Update Posted : December 12, 2013
Lung cancer is the leading cause of cancer-related death worldwide and is well known to remain a major health problem. Non-small-cell lung cancer (NSCLC) constitutes more than 80% of all the cases of lung cancer.
Today, NSCLC can be defined by various molecular criteria. Especially, somatic mutations within the epidermal growth factor receptor (EGFR) gene itself were discovered in a subset of NSCLC patients.
Two activating EGFR mutations are in-frame deletion in exon 19 and the substitutions for L858R in exon 21, which account for 85% of all clinically important mutations related to EGFR TKI sensitivity.
Besides two activating EGFR mutations, other EGFR mutations in NSCLC have been discovered. G719 and L861 are reported to have intermediate sensitivity to EGFR TKI. And in-frame insertions within exon 20 and T790, which are known to be resistant to EGFR TKIs.
However, there are still other EGFR mutations such as E709 and S768 as well as doublet EGFR mutations are also observed. These rare mutations have not been fully described and data on their correlation with response to EGFR-TKIs are still unclear.
Research hypothesis Rare EGFR mutations of unknown clinical significance in NSCLC patients, which are distinguish from mutations such as deletion in exon 19, L858 and insertion in exon 20, have some possibility of EGFR TKI sensitivity.
Rationale for conducting this study It has an opportunity to be shown the efficacy of EGFR TKIs in patients with rare EGFR mutation in large number of patients in Korea (Asia) during the short period.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||Efficacy of EGFR Tyrosine Kinase Inhibitors (EGFR TKIs) in Patients With EGFR-mutated Non-small Cell Lung Cancer Except Both Exon 19 Deletion and Exon 21 L859R: A Retrospective Analysis|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||February 2014|
- the efficacy of EGFR TKIs as defined by objective response rate [ Time Frame: up to 1 year ]
- the incidence of patients with rare EGFR mutated NSCLC [ Time Frame: up to 1 year ]
- the clinical characteristics of patients with rare EGFR mutated NSCLC [ Time Frame: up to 1 year ]
- the efficacy of EGFR TKIs as defined by disease control rate, progression-free survival and overall survival in the patients with rare EGFR mutated NSCLC [ Time Frame: up to 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775943
|Korea, Republic of|
|Ulsan University Hospital|
|Ulsan, Korea, Republic of, 682-060|
|Principal Investigator:||Young Joo Min, M.D.||Ulsan University Hospital|