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

An Observational Study to Evaluate AZD9291 Treatment in Patients With EGFR T790M Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer Following Progression on at Least One Prior EGFR TKI Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03457220

Enrollment

423

Registered

2018-03-07

Start date

2018-06-21

Completion date

2019-12-31

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Response Rate (RR)	Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months	RR is defined as the percentage of subjects with the best overall response of 'responding', which is defined as complete response (CR) or partial response (PR), by investigator's assessment
Disease Control Rate (DCR)	Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months	DCR is defined as the percentages of subjects who have the best overall response of CR, PR, or SD, which is determined by investigator's assessment.
Time to treatment discontinuation (TTD)	Time from patient first dose to data cut off (up to 32 months)	TTD is defined as the time interval (in months) from the date of the first dose of AZD9291 in the EAP until the date of the single use of AZD9291 discontinuation for any reason

Countries

Taiwan

Outcome results