T790M Positive NSCLC PatientsNCT03133234
Effect of Osimertinib in Ethnic Chinese With EGFR and T790M Mutated NSCLC
An observational study of T790M Positive NSCLC Patients, run by AstraZeneca at 1 site in China.
Trial summary
To assess the effectiveness and safety of osimertinib treatment in a real world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T790M Positive NSCLC Patients
- What is being tested?
- osimertinib
- Type of treatment
- Pill or oral medicine
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2017to 13 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed after EGFR TKI treatment.
Who may be able to join
- Above 18 years of age;
- Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
- Confirmed T790M mutation
- Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment
- Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016
Who cannot join
- Enrolment in studies that prohibit any participation in this observational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).
To assess the effectiveness and safety of osimertinib treatment in a real world setting.
Read the detailed description
The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.
- Conditions
- T790M Positive NSCLC Patients
- Being tested
- osimertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osimertinibDrug
Oral dose of 80mg once daily
| Study group | Role | What they receive |
|---|---|---|
| EGFR T790M Patients | Patients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI Receives: Drug: osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment
Measured: Followed up with 6 months after last patient in
Secondary outcomes (8)
PFS
Progression free survival (PFS), defined as the time from the date of first dose of osimertinib to the date of investigator-assessed disease progression or death from any cause during study. Subjects who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment
Measured: Followed up 10 months after last subject in
T790M mutation testing time
Average turnaround time.
Measured: Within 14 days after enrollment date
Treatment patterns
To assess by number of previous adopted/current/future therapies as recorded on the case report form
Measured: Followed up 10 months after last patient in
Adverse events
To assess by number of adverse events as recorded on the case report form.
Measured: Follow up 10 months after last patient in.
Adverse event intensity
To assess by intensity of adverse events as recorded on the case report form, which will be measured by CTCAE grade system
Measured: Follow up 10 months after last patient in.
T790M mutation testing sample
To assess by proportion of testing samples types as recorded on the case report form.
Measured: Within 14 days after enrollment date
T790M mutation testing platform
To assess by proportion of each testing platform as recorded on the case report form.
Measured: Within 14 days after enrollment date
EGFR testing mutation subtype
To assess by proportion of EGFR mutation subtype as recorded on the case report form
Measured: Within 14 days after enrollment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start23 May 2017
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T790M Positive NSCLC PatientsStudies 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yabing Cao, Principal investigator, Kiang Wu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133234
- Sponsor's protocol ID
- D5160R00016
- Status last verified
- Nov 2018
- First submitted
- 13 Apr 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cao Y, Qiu X, Xiao G, Hu H, Lin T. Effectiveness and safety of osimertinib in patients with metastatic EGFR T790M-positive NSCLC: An observational real-world study. PLoS One. 2019 Aug 23;14(8):e0221575. doi: 10.1371/journal.pone.0221575. eCollection 2019.
PubMed 31442277
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Retrospective, Real World Study of Osimertinib in Ethnic Chinese Patients With Locally Advanced/Metastatic T790M Mutation-Positive Non-small-cell Lung Cancer (NSCLC )Progressed on Previous Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI).
- ClinicalTrials.gov ID
- NCT03133234
- Acronym / sponsor ID
- D5160R00016
- Conditions
- T790M Positive NSCLC Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 May 2017 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 28 Apr 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 effectiveness and safety of osimertinib treatment in a real world setting.
Detailed description
The current study will not only assess the effectiveness of osimertinib treatment in a real world setting, but will also help us to understand the real-world testing patterns among T790M mutation positive locally advanced or metastatic NSCLC patients who have progressed after EGFR TKI treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR T790M Patients | – | Drug: osimertinibPatients with locally advanced/metastatic EGFR T790M positive NSCLC progressed on previous EGFR TKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed after EGFR TKI treatment.
Key inclusion criteria (5 listed)
- Above 18 years of age;
- Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
- Confirmed T790M mutation
- Progressed on previous EGFR TKI treatment. Patients may have also received additional lines of treatment
- Received osimertinib treatment in the participating site between May 1st and Oct 31st 2016
Key exclusion criteria (1 listed)
- Enrolment in studies that prohibit any 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 |
|---|---|---|
| osimertinibOral dose of 80mg once daily | Drug | EGFR T790M Patients |
Primary outcome
ORR
Time frame: Followed up with 6 months after last patient in
Overall response rate (ORR), defined as the proportion of patients with a best response of "responding" to treatment by investigator assessment
8 secondary outcomes
PFS
Time frame: Followed up 10 months after last subject in
T790M mutation testing time
Time frame: Within 14 days after enrollment date
Treatment patterns
Time frame: Followed up 10 months after last patient in
Adverse events
Time frame: Follow up 10 months after last patient in.
Adverse event intensity
Time frame: Follow up 10 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
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 20 Nov 2018.
- Derived from this study: PubMed 31442277Cao Y, Qiu X, Xiao G, Hu H, Lin T. Effectiveness and safety of osimertinib in patients with metastatic EGFR T790M-positive NSCLC: An observational real-world study. PLoS One. 2019 Aug 23;14(8):e0221575. doi: 10.1371/journal.pone.0221575. eCollection 2019.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Yabing Cao principal investigator
Kiang Wu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T790M Positive NSCLC Patients, run by AstraZeneca at 1 site 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
ORR (time frame: Followed up with 6 months after last patient in). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133234, which also lists 1 linked publication.
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 20 Nov 2018.