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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Young Joo Min, Ulsan University Hospital
ClinicalTrials.gov Identifier:
NCT01775943
First received: January 18, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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
Lung Neoplasms

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ulsan University Hospital:

Primary Outcome Measures:
  • the efficacy of EGFR TKIs as defined by objective response rate [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the incidence of patients with rare EGFR mutated NSCLC [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • the clinical characteristics of patients with rare EGFR mutated NSCLC [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

comprehensive cancer hospital

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775943

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

No publications provided

Responsible Party: Young Joo Min, Professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT01775943     History of Changes
Other Study ID Numbers: ISSIRES0070
Study First Received: January 18, 2013
Last Updated: December 10, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ulsan University Hospital:
Epidermal growth factor receptor
Mutation
Lung cancer
Drug sensitivity

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014