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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Young Joo Min, Ulsan University Hospital

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.

Condition or disease
Lung Neoplasms

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. the efficacy of EGFR TKIs as defined by objective response rate [ Time Frame: up to 1 year ]

Secondary Outcome Measures :
  1. the incidence of patients with rare EGFR mutated NSCLC [ Time Frame: up to 1 year ]

Other Outcome Measures:
  1. the clinical characteristics of patients with rare EGFR mutated NSCLC [ Time Frame: up to 1 year ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
comprehensive cancer hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01775943

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Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-060
Sponsors and Collaborators
Ulsan University Hospital
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Principal Investigator: Young Joo Min, M.D. Ulsan University Hospital

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Responsible Party: Young Joo Min, Professor, Ulsan University Hospital Identifier: NCT01775943    
Other Study ID Numbers: ISSIRES0070
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013
Keywords provided by Young Joo Min, Ulsan University Hospital:
Epidermal growth factor receptor
Lung cancer
Drug sensitivity
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases