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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457220
• Other study ID #: D5160R00021
• Status: Completed
• Start date: June 21, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan City
Taiwan	Research Site	Tainan City
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Response Rate (RR)	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	Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
Other	Disease Control Rate (DCR)	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.	Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
Other	Time to treatment discontinuation (TTD)	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	Time from patient first dose to data cut off (up to 32 months)
Primary	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	Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 12 months
Secondary	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	Every 12 weeks until treatment discontinuation as defined by RECIST 1.1 projected 24 months

External Links

•   CSR_Synopsis