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NCT01185314 Clinical Trial

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

Non Small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01185314
Other study ID # D7913L00086
Secondary ID
Status Completed
Phase N/A
First received August 16, 2010
Last updated August 5, 2011
Start date September 2010
Est. completion date July 2011

Study information
Verified date August 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeHong Kong: Ethics CommitteeIndia: Central Drugs Standard Control OrganizationIndia: Indian Council of Medical ResearchIndia: Ministry of HealthIndia: Ministry of Science and TechnologyIndia: Institutional Review BoardPhilippines: Bureau of Food and DrugsTaiwan: Department of HealthTaiwan: Institutional Review BoardThailand: Ethical Committee
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 1270
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Procedure:
• Testing for mutation status
EGFR mutation test

Locations
Country Name City State
China Research Site Beijing Beijing
China Research Site Changchun Jilin
China Research Site Chengdu Sichuan
China Research Site Guangzhou Guangdong
China Research Site Jinan Shandong
China Research Site Shanghai Shanghai
China Research Site Shenyang Liaoning
China Research Site Shijiazhuang Hebei
China Research Site Taiyuan Shanxi
China Research Site Tianjin Tianjin
China Research Site Wuhan Hubei
China Research Site Zhengzhou Henan
Hong Kong Research Site Hong Kong
India Research Site Chennai
India Research Site Kochi Kerala
India Research Site Kolkata
India Research Site Mumbai Maharashtra
India Research Site Pune Maharashtra
India Research Site Rohini Delhi
India Research Site Vadodara Gujarat
Philippines Research Site Cebu City
Philippines Research Site Manila City
Philippines Research Site Pasay City
Philippines Research Site Quezon City
Philippines Research Site Taguig City
Taiwan Research Site Chiayi
Taiwan Research Site Kaohsiung
Taiwan Research Site Taichung
Taiwan Research Site Tainan
Taiwan Research Site Taipei
Taiwan Research Site Tao-Yuan
Thailand Research Site Bangkok
Thailand Research Site Chiang Mai
Thailand Research Site Songkla
Vietnam Research Site Hanoi
Vietnam Research Site Ho Chi Minh City

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

China,  Hong Kong,  India,  Philippines,  Taiwan,  Thailand,  Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary EGFR mutation status of Asian patients with advanced NSCLC Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks. No
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