Back to resultsTo Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (PIONEER)
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Testing for mutation status
Sponsored by
About this trial
This is an interventional screening trial for Non Small Cell Lung Cancer focused on measuring NSCLC, EGFR mutation
Eligibility 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
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
EGFR mutation testing
Outcomes
Primary Outcome Measures
EGFR mutation status of Asian patients with advanced NSCLC
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01185314
Brief Title
To Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Acronym
PIONEER
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
A molecular epidemiology study in Asian patients with advanced NSCLC of adeno histology to assess EGFR mutation status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
NSCLC, EGFR mutation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
EGFR mutation testing
Intervention Type
Procedure
Intervention Name(s)
Testing for mutation status
Intervention Description
EGFR mutation test
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Yeoman, MBBS, MFPM
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robin Meng, MD, PhD
Organizational Affiliation
AstraZeneca Taiwan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yang Pan-Chyr, MD, PhD
Organizational Affiliation
National Taiwan University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
Research Site
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Research Site
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Research Site
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Research Site
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Facility Name
Research Site
City
Rohini
State/Province
Delhi
Country
India
Facility Name
Research Site
City
Vadodara
State/Province
Gujarat
Country
India
Facility Name
Research Site
City
Kochi
State/Province
Kerala
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Chennai
Country
India
Facility Name
Research Site
City
Kolkata
Country
India
Facility Name
Research Site
City
Cebu City
Country
Philippines
Facility Name
Research Site
City
Manila City
Country
Philippines
Facility Name
Research Site
City
Pasay City
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Taguig City
Country
Philippines
Facility Name
Research Site
City
Chiayi
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Tainan
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Tao-Yuan
Country
Taiwan
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
Facility Name
Research Site
City
Songkla
Country
Thailand
Facility Name
Research Site
City
Hanoi
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh City
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
To Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
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