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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Page 1 of 2 (7 locations)

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

An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer | DecenTrialz