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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


N/A
N/A
N/A
Not Enrolling
Both
Lung Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

the efficacy of EGFR TKIs as defined by objective response rate

Outcome Time Frame:

up to 1 year

Safety Issue:

No

Principal Investigator

Young Joo Min, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ulsan University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

ISSIRES0070

NCT ID:

NCT01775943

Start Date:

March 2013

Completion Date:

September 2013

Related Keywords:

  • Lung Neoplasms
  • Epidermal growth factor receptor
  • Mutation
  • Lung cancer
  • Drug sensitivity
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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