Study Stopped
The study direction does not longer aligns the sponsor's strategy
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
An Observational, Multi-centre Study on EGFR T790M Mutation Testing Practices and Outcomes Conducted Among Locally Advanced/Metastatic NSCLC Patients Who Progressed on Previous EGFR Tyrosine-kinase Inhibitor (TKI) Therapy in Hong Kong
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
To describe the T790M mutation status of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment in a real-world setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2018
Typical duration for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
May 9, 2018
CompletedStudy Start
First participant enrolled
September 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedNovember 16, 2018
November 1, 2018
2.2 years
February 19, 2018
November 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
EGFR T790M mutation prevalance
Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy
3 years
Secondary Outcomes (10)
Proportion of Valid Tissue T790M Testing Result
3 years
T790M Plasma Outcome
3 years
False Negative Proportation
3 years
Reasons for not performing re-biopsy
3 years
Demographics
Baseline
- +5 more secondary outcomes
Other Outcomes (1)
Concordance
3 years
Study Arms (1)
EGFR NSCLC Progressed on EGFR TKI
Patients with EGFR NSCLC who have progressed following EGFR TKI therapy will undergo plasma-tissue testing
Interventions
EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI
Eligibility Criteria
The study will enrol locally advanced or metastatic NSCLC patients with confirmed EGFR sensitizing mutation, who progressed after EGFR TKI treatment (i.e.,gefitinib, erlotinib, afatinib), and are suggested to undergo T790M mutation testing by their treating physicians in participating sites in Hong Kong
You may qualify if:
- Provision of written informed consent
- Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
- Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record
- Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment
- Suggested to undergo T790M mutation testing by treating physician, based on physician judgement
You may not qualify if:
- Had been treated with osimertinib or any other 3rd generation T790M inhibitors
- Enrollment in studies that prohibit participation in this observational study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Biospecimen
Plasma for T7909M ctDNA testing Urine for T7909M ctDNA testing Tissue (optional)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Ho, MBBS
Queen Mary Hospital, Hong Kong
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2018
First Posted
May 9, 2018
Study Start
September 30, 2018
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
November 16, 2018
Record last verified: 2018-11