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

• ClinicalTrials.gov Identifier: NCT03457220
• Recruitment Status: Completed
• First Posted: March 7, 2018
• Last Update Posted: December 21, 2020
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Tracking Information

• First Submitted Date: March 1, 2018
• First Posted Date: March 7, 2018
• Last Update Posted Date: December 21, 2020
• Actual Study Start Date: June 21, 2018
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 1, 2018)

Progression free survival (PFS) [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 1, 2018)

Overall survival (OS) [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 1, 2018)

• Response Rate (RR) [ Time Frame: 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) [ Time Frame: 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 Frame: 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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: An Observational Study to Evaluate AZD9291 Treatment in Patients With T790M Positive Non-small Cell Lung Cancer
• 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
• 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 Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: All the available patients who have participated in the AZD9291 EAP will be screened for the eligible criteria for data collection in this observational study
• Condition: Non Small Cell Lung Cancer
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 17, 2020): 423
• Original Estimated Enrollment (submitted: March 1, 2018): 600
• Actual Study Completion Date: December 31, 2019
• Actual Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT03457220
• Other Study ID Numbers: D5160R00021
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AstraZeneca
• Study Sponsor: AstraZeneca
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: AstraZeneca
• Verification Date: December 2020