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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

Study Description
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Brief Summary:
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Drug: Osimertinib

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 Design
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Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Actual Study Start Date : September 5, 2017
Actual Primary Completion Date : October 28, 2020
Actual Study Completion Date : October 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

Groups and Cohorts
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Group/Cohort Intervention/treatment
EGFR T790M positive NSCLC patients
Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment.
 Drug: Osimertinib
80mg oral daily


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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)

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed or discontinued from previous EGFR TKI treatment.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219970


Locations
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China
Pamela Youde Nethersole Eastern Hospital
Hong Kong, China
Prince of wales hospital
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Tuen Mun Hospital
Hong Kong, China
Sponsors and Collaborators
AstraZeneca
Investigators
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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
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03219970    
Other Study ID Numbers: D5160R00020
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (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
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Osimertinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action