Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC
NCT ID: NCT01775943
Last Updated: 2013-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2013-03-31
2014-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Confirmed EGFR rare mutations (EGFR mutation except both exon 19 deletion and exon 21 L858R) using direct DNA sequencing
3. Experiences of treatment with EGFR TKIs.
4. at least one measurable and/or evaluable lesion according to RECIST criteria (version 1.1)
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Ulsan University Hospital
OTHER
Responsible Party
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Young Joo Min
Professor
Principal Investigators
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Young Joo Min, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ulsan University Hospital
Locations
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Ulsan University Hospital
Ulsan, , South Korea
Countries
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Other Identifiers
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ISSIRES0070
Identifier Type: -
Identifier Source: org_study_id