Locally Advanced or Metastatic EGFR(+) NSCLC PatientsNCT02991274
ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory
An observational study of Locally Advanced or Metastatic EGFR(+) NSCLC Patients, run by AstraZeneca at 31 sites in China.
Trial summary
The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic EGFR(+) NSCLC Patients
- What is being tested?
- genomic testing of T790M mutation
- Type of treatment
- Surgery or procedure
- How many people
- 897 participants
- Where
- 31 sitesChina
- Study dates
- 16 Jan 2017to 29 Jun 2018
- 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
Who may be able to join
- Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
- Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.
- Patients who have progressed following prior therapy with an EGFR-TKI agent.
- Patients who consent to provide tumour tissue and/or blood.
Who cannot join
- Patients who disagree to participate this study.
- Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
China31 sites
Research Site
Beijing, 100021
Research Site
Beijing
Research Site
Changchun, 130012
Research Site
Changchun, 130021
Research Site
Chengdu, 610041
Research Site
Guangzhou, 510080
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310006
Research Site
Hangzhou, 310009
Research Site
Hangzhou, 310022
Research Site
Harbin, 150049
Research Site
Hefei, 230001
Research Site
Hohhot, 010017
Research Site
Jinan, 2501117
Research Site
Kunming, 650118
Research Site
Linhai, 317000
Research Site
Nanchang, 330006
Research Site
Nanjing, 210029
Research Site
Qingdao, 266071
Research Site
Shanghai, 200032
Research Site
Shanghai, 200433
Research Site
Shenyang, 110001
Research Site
Shenzhen, 518020
Research Site
Ürümqi, 830000
Research Site
Ürümqi, 830054
Research Site
Wuhan, 430022
Research Site
Wuhan, 430030
Research Site
Xi'an, 710061
Research Site
Xi'an
Research Site
Yantai, 264000
Research Site
Zhengzhou, 450008
About this study
Official title: A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing
The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory.
Read the detailed description
This is a multi-center testing study. 800 patients from 80 different hospital sites will have local T790M testing by different molecular testing platforms and have central testing by Cobas platform. These two sets of data (local T790M testing and central T790M testing) will be analysed and compared to assess the concordance of these T790M testing platforms.
- Being tested
- genomic testing of T790M mutation
- Keywords
- T790M, EGFR (Epidermal Growth Factor Receptor) mutation, NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genomic testing of T790M mutationProcedure or surgery
patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.
| Study group | Role | What they receive |
|---|---|---|
| T790M mutation test | genomic testing of T790M mutation Receives: Procedure: genomic testing of T790M mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the concordance of T790M mutation testing between the test in central and local labs
Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%
Measured: within 1 -14 days after enrolled
Secondary outcomes (8)
The prevalence rate of T790M mutation based on the central lab testing
Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%
Measured: within 1 -14 days after enrolled
The sensitivity of each platform based on the local lab plasma testing
Sensitivity (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on tissue test) ×100%
Measured: within 1 -14 days after enrolled
The Specificity of each platform based on the local lab plasma testing
Specificity (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on tissue test) ×100%
Measured: within 1 -14 days after enrolled
The Positive predictive value of each platform based on the local lab plasma testing
Positive predictive value (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on plasma test) ×100%
Measured: within 1 -14 days after enrolled
The Negative predictive value of each platform based on the local lab plasma testing
Negative predictive value (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on plasma test) ×100%
Measured: within 1 -14 days after enrolled
The Concordance of each platform based on the local lab testing
Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%
Measured: within 1 -14 days after enrolled
The prevalence of C797S (An amino acid substitution at position 797 in EGFR, from a Cysteine (C) to a Serine (S) ) resistance mutation based on the local lab testing
Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%
Measured: within 1 -14 days after enrolled
Rare EGFR mutation prevalence rate
Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100%
Measured: within 1-14 days after enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start16 Jan 2017
- Primary completion29 Jun 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic EGFR(+) 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
- Enrolment
- 897 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, ChinaJie He, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical SciencesJie Wang, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991274
- Sponsor's protocol ID
- D5160C00041
- Status last verified
- Jun 2019
- First submitted
- 9 Dec 2016
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing
- ClinicalTrials.gov ID
- NCT02991274
- Acronym / sponsor ID
- D5160C00041
- Keywords
- T790M, EGFR (Epidermal Growth Factor Receptor) mutation, NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 897 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory.
Detailed description
This is a multi-center testing study. 800 patients from 80 different hospital sites will have local T790M testing by different molecular testing platforms and have central testing by Cobas platform. These two sets of data (local T790M testing and central T790M testing) will be analysed and compared to assess the concordance of these T790M testing platforms.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T790M mutation test | – | Procedure: genomic testing of T790M mutationgenomic testing of T790M mutation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
- Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.
- Patients who have progressed following prior therapy with an EGFR-TKI agent.
- Patients who consent to provide tumour tissue and/or blood.
Key exclusion criteria (2 listed)
- Patients who disagree to participate this study.
- Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.
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 |
|---|---|---|
| genomic testing of T790M mutationpatients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory. | Procedure or surgery | T790M mutation test |
Primary outcome
the concordance of T790M mutation testing between the test in central and local labs
Time frame: within 1 -14 days after enrolled
Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%
8 secondary outcomes
The prevalence rate of T790M mutation based on the central lab testing
Time frame: within 1 -14 days after enrolled
The sensitivity of each platform based on the local lab plasma testing
Time frame: within 1 -14 days after enrolled
The Specificity of each platform based on the local lab plasma testing
Time frame: within 1 -14 days after enrolled
The Positive predictive value of each platform based on the local lab plasma testing
Time frame: within 1 -14 days after enrolled
The Negative predictive value of each platform based on the local lab plasma testing
Time frame: within 1 -14 days after enrolled
The Concordance of each platform based on the local lab testing
Time frame: within 1 -14 days after enrolled
The prevalence of C797S (An amino acid substitution at position 797 in EGFR, from a Cysteine (C) to a Serine (S) ) resistance mutation based on the local lab testing
Time frame: within 1 -14 days after enrolled
Rare EGFR mutation prevalence rate
Time frame: within 1-14 days after enrolled
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 12 Jun 2019.
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.
Caicun Zhou principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Jie He principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Jie Wang principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced or Metastatic EGFR(+) NSCLC Patients, run by AstraZeneca at 31 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 4 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: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
the concordance of T790M mutation testing between the test in central and local labs (time frame: within 1 -14 days after enrolled). 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 12 Jun 2019.