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Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.

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: NCT03219970
Recruitment Status : Completed
First Posted : July 18, 2017
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date July 14, 2017
First Posted Date July 18, 2017
Last Update Posted Date November 25, 2020
Actual Study Start Date September 5, 2017
Actual Primary Completion Date October 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 14, 2017)
Association between T790M mutant status and overal survival [ Time Frame: Followed up to 2 years after last patient in ]
To assess the association of EGFR T790M mutant allele fraction (AF) level with the overall survival (OS) of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 14, 2017)
  • Overal survival (OS) [ Time Frame: Followed up to 2 years after last patient in ]
    To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
  • RR [ Time Frame: Follow up within 6 months after last patient in ]
    To estimate response rate (RR) and disease control rate (DCR) based on physician's judgement, for the overall study population.
  • TTD [ Time Frame: Followed up to 12 months after last patient in ]
    To estimate time to treatment discontinuation (TTD) of osimertinib for the overall study population, and for subjects with different EGFR mutation status (T790M/Exon 19 del; T790M/L858R)
  • Adverse event of special interest [ Time Frame: Followed up to 12 months after last patient in ]
    To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form.
  • T790M mutation testing sample [ Time Frame: Within 14 days after enrollment date ]
    To describe what sample or biopsy collected for testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population
  • T790M mutation testing platform [ Time Frame: Within 14 days after enrollment date ]
    To describe the characteristics of the methods used for T790M mutation testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population
  • EGFR testing mutation subtype [ Time Frame: Within 14 days after enrollment date ]
    To describe the EGFR mutation status of study subjects after disease progression on, or discontinuation of, EGFR TKI therapy
  • Treatment pattern [ Time Frame: Followed up to 2 years after last patient in ]
    To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Official Title An Observational, Non-interventional, Multi-center, Chart Review Study Conducted Among Patients Enrolled in an AZD9291 Early Access Program in Hong Kong, With Locally Advanced/Metastatic EGFR T790M Mutation-positive NSCLC and Prior Exposure to EGFR TKI Therapy.
Brief Summary To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
Detailed Description This study will assess the efficacy and safety of single-agent osimertinib in patients with locally advanced or metastatic EGFR T790M-positive NSCLC within the context of the early access program in Hong Kong. In particular, osimertinib treatment efficacy will be assessed in the context of the relationship between EGFR T790M mutant AF and survival outcomes, particularly overall survival. In a real-world setting, analysis of overall survival benefit is considered less sensitive to differences in healthcare systems and standards. Other clinical outcomes including response rate (based on physician's judgement) and time to treatment discontinuation (TTD) will be examined. This study will also describe current practice for molecular testing and EGFR mutation profiles in this patient population.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed or discontinued from previous EGFR TKI treatment.
Condition Non-small Cell Lung Cancer
Intervention Drug: Osimertinib
80mg oral daily
Study Groups/Cohorts EGFR T790M positive NSCLC patients
Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment.
Intervention: Drug: Osimertinib
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: April 30, 2018)
156
Original Estimated Enrollment
 (submitted: July 14, 2017)
250
Actual Study Completion Date October 28, 2020
Actual Primary Completion Date October 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients enrolled in AZD9291 Named Patient Program in Hong Kong
  • Patients with confirmed advanced (locally advanced (stage IIIB) or metastatic (stage IV)) NSCLC with a positive test result for the EGFR T790M mutation
  • Patients who have previously received EGFR TKI therapy or discontinued an EGFR TKI at the time of enrolment in the study
  • Provision of written informed consent (for patients alive at the time of study enrolment)
  • Documented patients with trackable medical records

Exclusion Criteria:

  • Enrolment in studies that prohibit any participation in this non-interventional study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03219970
Other Study ID Numbers D5160R00020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Principal Investigator: Siu Hong, Oscar CHAN Pamela Youde Nethersole Eastern Hospital
Principal Investigator: Kwok Chi LAM Prince of Wales Hospital
Principal Investigator: Ho Fun, Victor LEE Queen Mary Hospital, Hong Kong
Principal Investigator: Shi Feng NYAW Tuen Mun Hospital
PRS Account AstraZeneca
Verification Date November 2020