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

AstraZeneca423 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

423

Conditions

Non Small Cell Lung Cancer

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (7)

Research Site

Kaohsiung City, Taiwan

Research Site

Kaohsiung City, Taiwan

Research Site

Taichung, Taiwan

Research Site

Tainan, Taiwan

Outcomes

Primary Outcomes

Progression free survival (PFS)

PFS is defined as the time interval (in months) from the first dose of AZD9291 in the EAP to the date of disease progression

Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months

Secondary Outcomes

Overall survival (OS)

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

Time frame: Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.