Europe-Japan Diagnostic Study for EGFR Testing (ASSESS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01785888
First received: February 4, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Describe the first line therapy choice following EGFR mutation testing. [ Time Frame: From randomization until study completion, assessed up to 17 months. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Tumour samples (biopsy or citology) Blood (plasma) samples


Enrollment: 1307
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785888

  Show 57 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rose McCormack, PhD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01785888     History of Changes
Other Study ID Numbers: D7913C00070
Study First Received: February 4, 2013
Last Updated: April 10, 2014
Health Authority: United Kingdom: National Health Service
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Spain: Ethics Committee
Sweden: Institutional Review Board
Japan: Institutional Review Board

Keywords provided by AstraZeneca:
EGFR,
aNSCLC,
mutation status,
diagnostic study,
Europe,
Japan

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasm Metastasis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014