Status:
COMPLETED
Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Lead Sponsor:
AstraZeneca
Conditions:
Caucasian Patients With EGFR Mutation Positive Advanced NSCLC
Eligibility:
All Genders
18-130 years
Phase:
PHASE4
Brief Summary
This study is carried out to see how Caucasian patients with lung cancer which has EGFR mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also be collected and a...
Detailed Description
An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who have Epidermal Growt...
Eligibility Criteria
Inclusion
- Locally advanced or metastatic non-small cell lung cancer (i.e. cancer that has spread from where it started) which is EGFR mutation positive
- Caucasian female or male patients aged 18 years or over
- Measurable disease, i.e. at least one lesion, not previously irradiated, as ≥ 10 mm in the longest diameter (≥ 15 mm in short axis for lymph node )
Exclusion
- Prior adjuvant chemotherapy or other systemic anti-cancer treatment less than 6 month, or palliative radiotherapy less than 4 weeks prior to start of study treatment.
- Brain metastases or spinal cord compression, unless treated and stable without steroids
- Any clinically significant illness, which will jeopardize the patients' safety and their participation in the study.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
1060 Patients enrolled
Trial Details
Trial ID
NCT01203917
Start Date
September 1 2010
End Date
June 1 2016
Last Update
January 2 2017
Active Locations (61)
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1
Research Site
Plovdiv, Bulgaria
2
Research Site
Sofia, Bulgaria
3
Research Site
Stara Zagora, Bulgaria
4
Research Site
Varna, Bulgaria