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

Completed

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT03457220
• Lead Sponsor: AstraZeneca

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 who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

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 who received at least one prior EGFR TKI therapy. At the end of September 2016, more than 450 patients have been under AZD9291 treatment through the EAP. This observational study aims to evaluate the clinical benefit of AZD9291 treatment for these patients who were in the EAP

Study Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-07
• Study Start: 2018-06-21
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

• 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 Criteria

• Patients who did not receive at least one dose of EGFR TKI for the treatment of EGFR mutation (+) NSCLC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months	PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months	OS is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of death due to any cause

Trial Locations

Locations (1)

Research Site; 🇨🇳 Taipei, Taiwan