Europe-Japan Diagnostic Study for EGFR Testing (ASSESS)

September 19, 2016 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Detailed Description

A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing,

Study Type

Observational

Enrollment (Actual)

1311

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Compiegne, France
        • Research Site
      • Gap, France
        • Research Site
      • Le Mans, France
        • Research Site
      • Longjumeau, France
        • Research Site
      • MEAUX Cedex, France
        • Research Site
      • Saint-Brieuc, France
        • Research Site
      • Saint-Michel, France
        • Research Site
      • Saint-Quentin, France
        • Research Site
      • Villefranche-sur-Saône Cedex, France
        • Research Site
  • Germany
      • Berlin-Buch, Germany
        • Research Site
      • Großhansdorf, Germany
        • Research Site
      • Halle, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Hemer, Germany
        • Research Site
      • Karlsruhe, Germany
        • Research Site
      • Löwenstein, Germany
        • Research Site
      • Münnerstadt, Germany
        • Research Site
      • Nürnberg, Germany
        • Research Site
      • Solingen, Germany
        • Research Site
  • Italy
      • Bari, Italy
        • Research Site
      • Bologna, Italy
        • Research Site
      • Lecce, Italy
        • Research Site
      • Monza, Italy
        • Research Site
      • Napoli, Italy
        • Research Site
      • Orbassano (TO), Italy
        • Research Site
      • Perugia, Italy
        • Research Site
      • Rome, Italy
        • Research Site
  • Japan
      • Hirakata, Japan
        • Research Site
      • Iizuka, Japan
        • Research Site
      • Kanazawa, Japan
        • Research Site
      • Mibu, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
      • Nagoya, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Toyonaka, Japan
        • Research Site
  • Netherlands
      • 's Hertogenbosch, Netherlands
        • Research Site
      • Arnhem, Netherlands
        • Research Site
      • Bergen op Zoom, Netherlands
        • Research Site
      • Breda, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Burgos, Spain
        • Research Site
      • Cruces, Spain
        • Research Site
      • Donostia, Spain
        • Research Site
      • Leon, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Pontevedra, Spain
        • Research Site
  • Sweden
      • Gävle, Sweden
        • Research Site
      • Karlstad, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
  • United Kingdom
      • Cardiff, United Kingdom
        • Research Site
      • Leeds, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From randomization until study completion, assessed up to 17 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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.
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.
From randomization until study completion, assessed up to 17 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Rose McCormack, PhD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D7913C00070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.

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