Non-small Cell Lung CancerNCT03219970
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 4 sites in China.
Trial summary
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) 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?
- Osimertinib
- Type of treatment
- Pill or oral medicine
- How many people
- 156 participants
- Where
- 4 sitesChina
- Study dates
- 5 Sep 2017to 28 Oct 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: Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed or discontinued from previous EGFR TKI treatment.
Who may be able to join
- 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
Who cannot join
- Enrolment in studies that prohibit any participation in this non-interventional study
Trial locations and contacts
4 sites in 1 country.
China4 sites
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Prince of wales hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
About this study
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.
To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele fraction (AF) in a real-world setting.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Osimertinib
- 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.
OsimertinibDrug
80mg oral daily
| Study group | Role | What they receive |
|---|---|---|
| EGFR T790M positive NSCLC patients | Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment. Receives: Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Followed up to 2 years after last patient in
Secondary outcomes (8)
Overal survival (OS)
To estimate OS of subjects with advanced/metastatic EGFR T790M-positive NSCLC treated with osimertinib
Measured: Followed up to 2 years after last patient in
RR
To estimate response rate (RR) and disease control rate (DCR) based on physician's judgement, for the overall study population.
Measured: Follow up within 6 months after last patient in
TTD
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)
Measured: Followed up to 12 months after last patient in
Adverse event of special interest
To assess by number of adverse events of special interest which are pre-defined in protocol, as recorded on the case report form.
Measured: Followed up to 12 months after last patient in
T790M mutation testing sample
To describe what sample or biopsy collected for testing after disease progression on, or discontinuation of, EGFR TKI therapy in the study population
Measured: Within 14 days after enrollment date
T790M mutation testing platform
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
Measured: Within 14 days after enrollment date
EGFR testing mutation subtype
To describe the EGFR mutation status of study subjects after disease progression on, or discontinuation of, EGFR TKI therapy
Measured: Within 14 days after enrollment date
Treatment pattern
To describe treatment regimens received by study subjects before and after the start of osimertinib therapy.
Measured: Followed up to 2 years after last patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start5 Sep 2017
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
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
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siu Hong, Oscar CHAN, Principal investigator, Pamela Youde Nethersole Eastern HospitalKwok Chi LAM, Principal investigator, Prince of Wales Hospital, Shatin, Hong KongHo Fun, Victor LEE, Principal investigator, Queen Mary Hospital, Hong KongShi Feng NYAW, Principal investigator, Tuen Mun Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219970
- Sponsor's protocol ID
- D5160R00020
- Status last verified
- Sep 2021
- First submitted
- 14 Jul 2017
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03219970
- Acronym / sponsor ID
- D5160R00020
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 18 Jul 2017 (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 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR T790M positive NSCLC patients | – | Drug: OsimertinibPatients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI treatment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed or discontinued from previous EGFR TKI treatment.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Enrolment in studies that prohibit any participation in this non-interventional 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 |
|---|---|---|
| Osimertinib80mg oral daily | Drug | EGFR T790M positive NSCLC patients |
Primary outcome
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
8 secondary outcomes
Overal survival (OS)
Time frame: Followed up to 2 years after last patient in
RR
Time frame: Follow up within 6 months after last patient in
TTD
Time frame: Followed up to 12 months after last patient in
Adverse event of special interest
Time frame: Followed up to 12 months after last patient in
T790M mutation testing sample
Time frame: Within 14 days after enrollment date
T790M mutation testing platform
Time frame: Within 14 days after enrollment date
EGFR testing mutation subtype
Time frame: Within 14 days after enrollment date
Treatment pattern
Time frame: Followed up to 2 years after last patient in
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Redacted SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Siu Hong, Oscar CHAN principal investigator
Pamela Youde Nethersole Eastern Hospital
Kwok Chi LAM principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
Ho Fun, Victor LEE principal investigator
Queen Mary Hospital, Hong Kong
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by AstraZeneca at 4 sites in China.
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 1 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: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association between T790M mutant status and overal survival (time frame: Followed up to 2 years after last patient in). 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 14 Sep 2021.