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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01185314
First received: August 16, 2010
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  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: 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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Gerard Lynch, AstraZeneca
ClinicalTrials.gov Identifier: NCT01185314     History of Changes
Other Study ID Numbers: D7913L00086
Study First Received: August 16, 2010
Last Updated: August 5, 2011
Health Authority: China: Ethics Committee
Hong Kong: Ethics Committee
India: Central Drugs Standard Control Organization
India: Indian Council of Medical Research
India: Ministry of Health
India: Ministry of Science and Technology
India: Institutional Review Board
Philippines: Bureau of Food and Drugs
Taiwan: Department of Health
Taiwan: Institutional Review Board
Thailand: Ethical Committee

Keywords provided by AstraZeneca:
NSCLC, EGFR mutation

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

ClinicalTrials.gov processed this record on May 16, 2013