An observational study in Lung Neoplasms, sponsored by Ulsan University Hospital. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2013-12-12.
Sponsored by Ulsan University Hospital · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 90 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Ulsan University Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
comprehensive cancer hospital
Inclusion Criteria:
Exclusion Criteria:Subjects should not enter the study if any of the following exclusion criteria are fulfilled: EGFR wild type, EGFR exon 19 deletion alone, EGFR L858R alone
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
This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Ulsan University Hospital