EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.ASSESSNCT01785888
Europe-Japan Diagnostic Study for EGFR Testing
An observational study of EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies., run by AstraZeneca at 57 sites in 8 countries.
Trial summary
This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.
- How many people
- 1,311 participants
- Where
- 57 sitesin 8 countries
- Study dates
- Apr 2013to Apr 2014
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients with locally advanced (stage IIIA/B) or metastatic NSCLC who are newly diagnosed, have not received any local or systemic chemotherapy. Locally advanced patients should not be eligible for curative treatment (including surgery and chemoradiotherapy). * Patients who have newly diagnosed locally advanced (stage IIIA/B) NSCLC who are not eligible for curative treatment (including surgery and chemoradiotherapy) or metastatic NSCLC and have not received systemic chemotherapy. Previous or planned palliative radiotherapy is allowed. * Patients who have had surgical resection with or without adjuvant chemotherapy and have experienced recurrent disease.
Who may be able to join
- Patients aged 18 years and older in Europe and aged 20 years and older in Japan
- Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC.
- Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
- Provision of diagnostic cancer tissue or cytology sample upon inclusion
- Provision of a routine blood sample
Who cannot join
- Evidence of severe or uncontrolled systemic disease
- Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
- Pregnancy or breast-feeding
Trial locations and contacts
57 sites in 8 countries.
57 sites in 8 countries
Germany10 sites
Research Site
Buch
Research Site
Großhansdorf
Research Site
Halle
Research Site
Hamburg
Research Site
Hemer
Research Site
Karlsruhe
Research Site
Löwenstein
Research Site
Münnerstadt
Research Site
Nuremberg
Research Site
Solingen
France9 sites
Research Site
Compiègne
Research Site
Gap
Research Site
Le Mans
Research Site
Longjumeau
Research Site
Meaux
Research Site
Saint-Brieuc
Research Site
Saint-Michel
Research Site
Saint-Quentin
Research Site
Villefranche-sur-Saône
Italy8 sites
Research Site
Bari
Research Site
Bologna
Research Site
Lecce
Research Site
Monza
Research Site
Naples
Research Site
Orbassano (TO)
Research Site
Perugia
Research Site
Rome
Japan8 sites
Research Site
Hirakata
Research Site
Iizuka
Research Site
Kanazawa
Research Site
Mibu
Research Site
Nagasaki
Research Site
Nagoya
Research Site
Tokyo
Research Site
Toyonaka
Spain7 sites
Research Site
Barcelona
Research Site
Burgos
Research Site
Cruces
Research Site
Donostia / San Sebastian
Research Site
León
Research Site
Madrid
Research Site
Pontevedra
Netherlands6 sites
Research Site
's-Hertogenbosch
Research Site
Arnhem
Research Site
Bergen op Zoom
Research Site
Breda
Research Site
Nieuwegein
Research Site
Rotterdam
United Kingdom6 sites
Research Site
Cardiff
Research Site
Leeds
Research Site
Liverpool
Research Site
London
Research Site
Manchester
Research Site
Sheffield
About this study
Official title: A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,
This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.
Read the detailed description
A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing,
- Keywords
- EGFR,, aNSCLC,, mutation status,, diagnostic study,, Europe,, Japan
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Locally advanced/metastatic NSCLC pts. | Patients(pts.) with locally advanced (stage IIIA/B) or metastatic NSCLC who have not received any local or systemic chemotherapy, and are not eligible for curative treatment (including surgery and chemoradiotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the level of concordance between EGFR mutation status obtained via tissue/cytology and blood (plasma) based testing.
Measured: From randomization until study completion, assessed up to 17 months
Secondary outcomes (6)
Determination of the EGFR mutation frequency (including mutation subtypes) in patients with advanced NSCLC (aNSCLC) of adenocarcinoma and non-adenocarcinoma histologies.
Measured: From randomization until study completion, assessed up to 17 months.
Describe the first line therapy choice following EGFR mutation testing.
Measured: From randomization until study completion, assessed up to 17 months.
Describe the second line therapy choice following discontinuation of first line treatment for patients confirmed as EGFR mutation positive via tissue/cytology.
Measured: From randomization until study completion, assessed up to 17 months.
Summary of EGFR mutation testing practices in terms of methods, sample types, success rate, mutation detection rate, testing turnaround time and reasons for not testing.
Measured: From randomization until study completion, assessed up to 17 months.
Determination of the correlation between EGFR mutation status from tumour and demographic data and disease status.
Measured: From randomization until study completion, assessed up to 17 months.
Determination of the correlation between EGFR mutation status derived from plasma (blood) and demographic data and disease status.
Measured: From randomization until study completion, assessed up to 17 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.Studies 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
- 1,311 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rose McCormack, PhD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785888
- Sponsor's protocol ID
- D7913C00070
- Acronym
- ASSESS
- Status last verified
- Sep 2016
- First submitted
- 4 Feb 2013
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,
- ClinicalTrials.gov ID
- NCT01785888
- Acronym / sponsor ID
- ASSESS / D7913C00070
- Keywords
- EGFR,, aNSCLC,, mutation status,, diagnostic study,, Europe,, Japan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,311 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Feb 2013 (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.
This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.
Detailed description
A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally advanced/metastatic NSCLC pts. | – | –Patients(pts.) with locally advanced (stage IIIA/B) or metastatic NSCLC who have not received any local or systemic chemotherapy, and are not eligible for curative treatment (including surgery and chemoradiotherapy) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with locally advanced (stage IIIA/B) or metastatic NSCLC who are newly diagnosed, have not received any local or systemic chemotherapy. Locally advanced patients should not be eligible for curative treatment (including surgery and chemoradiotherapy). * Patients who have newly diagnosed locally advanced (stage IIIA/B) NSCLC who are not eligible for curative treatment (including surgery and chemoradiotherapy) or metastatic NSCLC and have not received systemic chemotherapy. Previous or planned palliative radiotherapy is allowed. * Patients who have had surgical resection with or without adjuvant chemotherapy and have experienced recurrent disease.
Key inclusion criteria (5 listed)
- Patients aged 18 years and older in Europe and aged 20 years and older in Japan
- Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC.
- Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
- Provision of diagnostic cancer tissue or cytology sample upon inclusion
- Provision of a routine blood sample
Key exclusion criteria (3 listed)
- Evidence of severe or uncontrolled systemic disease
- Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
- Pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of the level of concordance between EGFR mutation status obtained via tissue/cytology and blood (plasma) based testing.
Time frame: From randomization until study completion, assessed up to 17 months
6 secondary outcomes
Determination of the EGFR mutation frequency (including mutation subtypes) in patients with advanced NSCLC (aNSCLC) of adenocarcinoma and non-adenocarcinoma histologies.
Time frame: From randomization until study completion, assessed up to 17 months.
Describe the first line therapy choice following EGFR mutation testing.
Time frame: From randomization until study completion, assessed up to 17 months.
Describe the second line therapy choice following discontinuation of first line treatment for patients confirmed as EGFR mutation positive via tissue/cytology.
Time frame: From randomization until study completion, assessed up to 17 months.
Summary of EGFR mutation testing practices in terms of methods, sample types, success rate, mutation detection rate, testing turnaround time and reasons for not testing.
Time frame: From randomization until study completion, assessed up to 17 months.
Determination of the correlation between EGFR mutation status from tumour and demographic data and disease status.
Time frame: From randomization until study completion, assessed up to 17 months.
Determination of the correlation between EGFR mutation status derived from plasma (blood) and demographic data and disease status.
Time frame: From randomization until study completion, assessed up to 17 months.
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 Sep 2016.
- CSR\_Synopsis\_D7913C00070.pdfLink provided by the sponsor.
- redacted protocolLink provided by the sponsor.
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.
Rose McCormack, PhD study director
AstraZeneca
57 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies., run by AstraZeneca at 57 sites in 8 countries.
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 3 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 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Germany, France, Italy, Japan, Spain and 3 more countries. 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?
Determination of the level of concordance between EGFR mutation status obtained via tissue/cytology and blood (plasma) based testing. (time frame: From randomization until study completion, assessed up to 17 months). 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 20 Sep 2016; AzTrials last refreshed its copy on 31 Oct 2026.