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To Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (PIONEER)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185314
First Posted: August 19, 2010
Last Update Posted: August 8, 2011
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.
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to study the changes in protein in lung cells of Asian patients with advanced non small cell lung cancer.

Condition Intervention
Non Small Cell Lung Cancer Procedure: Testing for mutation status

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Molecular Epidemiology Study in Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC) of Adeno Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • EGFR mutation status of Asian patients with advanced NSCLC [ Time Frame: Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks. ]

Estimated Enrollment: 1270
Study Start Date: September 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
EGFR mutation testing
Procedure: Testing for mutation status
EGFR mutation test

Detailed Description:
A molecular epidemiology study in Asian patients with advanced NSCLC of adeno histology to assess EGFR mutation status.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytologically confirmed advanced Non small cell lung cancer of adeno histology NSCLC treatment naive Availability of cancer tissue or cytology sample

Exclusion Criteria:

  • Involvement in the planning and/or conduct of the study Previous enrollment in the present study
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01185314


  Show 36 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Guy Yeoman, MBBS, MFPM AstraZeneca
Study Chair: Robin Meng, MD, PhD AstraZeneca Taiwan
Principal Investigator: Yang Pan-Chyr, MD, PhD National Taiwan University College of Medicine
  More Information

Responsible Party: Gerard Lynch, AstraZeneca
ClinicalTrials.gov Identifier: NCT01185314     History of Changes
Other Study ID Numbers: D7913L00086
First Submitted: August 16, 2010
First Posted: August 19, 2010
Last Update Posted: August 8, 2011
Last Verified: August 2011

Keywords provided by AstraZeneca:
NSCLC, EGFR mutation

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms