Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03457220
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : December 21, 2020
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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