Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
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.
1 other identifier
observational
156
1 country
4
Brief Summary
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedStudy Start
First participant enrolled
September 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2020
CompletedSeptember 14, 2021
September 1, 2021
3.1 years
July 14, 2017
September 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Association between T790M mutant status and overal survival
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
Followed up to 2 years after last patient in
Secondary Outcomes (8)
Overal survival (OS)
Followed up to 2 years after last patient in
RR
Follow up within 6 months after last patient in
TTD
Followed up to 12 months after last patient in
Adverse event of special interest
Followed up to 12 months after last patient in
T790M mutation testing sample
Within 14 days after enrollment date
- +3 more secondary outcomes
Study Arms (1)
EGFR T790M positive NSCLC patients
Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment.
Interventions
Eligibility Criteria
Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed or discontinued from previous EGFR TKI treatment.
You may qualify if:
- 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
You may not qualify if:
- Enrolment in studies that prohibit any participation in this non-interventional study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (4)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2017
First Posted
July 18, 2017
Study Start
September 5, 2017
Primary Completion
October 28, 2020
Study Completion
October 28, 2020
Last Updated
September 14, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- 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.
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.