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Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC

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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
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Young Joo Min, Ulsan University Hospital

Tracking Information
First Submitted Date January 18, 2013
First Posted Date January 25, 2013
Last Update Posted Date December 12, 2013
Study Start Date March 2013
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 22, 2013)
the efficacy of EGFR TKIs as defined by objective response rate [ Time Frame: up to 1 year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01775943 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 22, 2013)
the incidence of patients with rare EGFR mutated NSCLC [ Time Frame: up to 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 22, 2013)
  • 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 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Efficacy of EGFR TKIs in Patients With Rare EGFR-mutated NSCLC
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
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population comprehensive cancer hospital
Condition Lung Neoplasms
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 22, 2013)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Histological confirmed non-small cell lung cancer (NSCLC), Stage IIIB or stage IV, between January 1, 2008 to December 31, 2011
  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)

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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01775943
Other Study ID Numbers ISSIRES0070
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Young Joo Min, Ulsan University Hospital
Study Sponsor Ulsan University Hospital
Collaborators AstraZeneca
Investigators
Principal Investigator: Young Joo Min, M.D. Ulsan University Hospital
PRS Account Ulsan University Hospital
Verification Date December 2013