Non-small Cell Lung CancerNCT03519958
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Plasma-tissue testing
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2018to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- Had been treated with osimertinib or any other 3rd generation T790M inhibitors
- Enrollment in studies that prohibit participation in this observational study
About this study
Official title: 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
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.
Read the detailed description
This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. Eligible patients will be recruited from participating sites in Hong Kong over a 12 months enrolment period.
Plasma and urine samples will be collected from enrolled patients. Plasma circulating tumor DNA (ctDNA) and urine ctDNA will be analyzed by droplet digital PCR (ddPCR) for detection of T790M mutation and EGFR sensitizing mutations. Patients who are T790M plasma-negative, regardless of the urine testing results, will be recommended to undergo re-biopsy (defined as tissue sampling or cytology sampling), tissue/cytology T790M testing, and to provide a second plasma sample for a second plasma T790M test (tested by ddPCR).
Enrolled patients who subsequently receive osimertinib treatment will be followed up as per routine practice at the investigational site. Patient data will be collected for 12 months or until death or loss to follow-up, whichever occurs earlier, from the first prescription of osimertinib. All clinical decisions will be at the discretion of the treating physician.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Plasma-tissue testing
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma-tissue testingDiagnostic test
EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI
| Study group | Role | What they receive |
|---|---|---|
| EGFR NSCLC Progressed on EGFR TKI | Patients with EGFR NSCLC who have progressed following EGFR TKI therapy will undergo plasma-tissue testing Receives: Diagnostic Test: Plasma-tissue testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
EGFR T790M mutation prevalance
Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy
Measured: 3 years
Secondary outcomes (10)
Proportion of Valid Tissue T790M Testing Result
Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation
Measured: 3 years
T790M Plasma Outcome
Proportions of study subjects who are T790M plasma-negative
Measured: 3 years
False Negative Proportation
Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive
Measured: 3 years
Reasons for not performing re-biopsy
reasons given for not performing re-biopsy and tissue/cytology testing after obtaining a negative plasma test result
Measured: 3 years
Demographics
Demographics of T790M-positive subjects and T790M-negative subjects
Measured: Baseline
Disease Characteristics
Disease characteristics of T790M-positive subjects and T790M-negative subjects
Measured: 3 years
Number of particapants with complications assoicated with re-biopsy
Number of particapants with complications assoicated with tissue/cytology re-biopsy
Measured: 3 years
Clinical Outcomes in T790M plasma-positive subejects
Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive
Measured: 3 years
Clinical Outcomes in urine-positive
Clinical outcomes after osimertinib treatment between study subjects who are urine-positive
Measured: 3 years
Clinical Outcomes in tissue/cytology-positive
Clinical outcomes after osimertinib treatment between study subjects who are tissue/cytology-positive
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start30 Sep 2018 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Why it stopped: The study direction does not longer aligns the sponsor's strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Ho, MBBS, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519958
- Sponsor's protocol ID
- D5160R00019
- Status last verified
- Nov 2018
- First submitted
- 19 Feb 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03519958
- Acronym / sponsor ID
- D5160R00019
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study direction does not longer aligns the sponsor's strategy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2018 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. Eligible patients will be recruited from participating sites in Hong Kong over a 12 months enrolment period.
Plasma and urine samples will be collected from enrolled patients. Plasma circulating tumor DNA (ctDNA) and urine ctDNA will be analyzed by droplet digital PCR (ddPCR) for detection of T790M mutation and EGFR sensitizing mutations. Patients who are T790M plasma-negative, regardless of the urine testing results, will be recommended to undergo re-biopsy (defined as tissue sampling or cytology sampling), tissue/cytology T790M testing, and to provide a second plasma sample for a second plasma T790M test (tested by ddPCR).
Enrolled patients who subsequently receive osimertinib treatment will be followed up as per routine practice at the investigational site. Patient data will be collected for 12 months or until death or loss to follow-up, whichever occurs earlier, from the first prescription of osimertinib. All clinical decisions will be at the discretion of the treating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR NSCLC Progressed on EGFR TKI | – | Diagnostic Test: Plasma-tissue testingPatients with EGFR NSCLC who have progressed following EGFR TKI therapy will undergo plasma-tissue testing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Had been treated with osimertinib or any other 3rd generation T790M inhibitors
- Enrollment in studies that prohibit participation in this observational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma-tissue testingEGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI | Diagnostic test | EGFR NSCLC Progressed on EGFR TKI |
Primary outcome
EGFR T790M mutation prevalance
Time frame: 3 years
Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy
10 secondary outcomes
Proportion of Valid Tissue T790M Testing Result
Time frame: 3 years
T790M Plasma Outcome
Time frame: 3 years
False Negative Proportation
Time frame: 3 years
Reasons for not performing re-biopsy
Time frame: 3 years
Demographics
Time frame: Baseline
Disease Characteristics
Time frame: 3 years
Number of particapants with complications assoicated with re-biopsy
Time frame: 3 years
Clinical Outcomes in T790M plasma-positive subejects
Time frame: 3 years
Clinical Outcomes in urine-positive
Time frame: 3 years
Clinical Outcomes in tissue/cytology-positive
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Ho, MBBS principal investigator
Queen Mary Hospital, Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EGFR T790M mutation prevalance (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.