Status:
COMPLETED
An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer
Lead Sponsor:
AstraZeneca
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
Brief Summary
AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients ...
Detailed Description
AZD9291 Early Access Program (EAP) was available in Taiwan during October 2015 to September 2016, a time period before the approval of AZD9291, to supply the unlicensed AZD9291 for the NSCLC patients ...
Eligibility Criteria
Inclusion
- At least 20 years of age
- Patients who were in the AZD9291 Early Access Program
- Received at least one dose of AZD9291 treatment as mono-therapy, supported by available source documents
- Patient who discontinued the single use of AZD9291, had disease progression, or died under AZD9291 treatment, whichever comes last, during the period from October 01, 2015 to December 31, 2018
- Patients agree to provide the written informed consent or the informed consent is waived by IRB.
Exclusion
- • Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC
Key Trial Info
Start Date :
June 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT03457220
Start Date
June 21 2018
End Date
December 31 2019
Last Update
December 21 2020
Active Locations (7)
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1
Research Site
Kaohsiung City, Taiwan, 807
2
Research Site
Kaohsiung City, Taiwan, 83301
3
Research Site
Taichung, Taiwan, 40705
4
Research Site
Tainan, Taiwan, 70403