Clinical trial NCT01785888: Europe-Japan Diagnostic Study for EGFR Testing
Official title: A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.
Keywords: EGFR,
aNSCLC,
mutation status,
diagnostic study,
Europe,
Japan
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-07
Enrollment: 1311
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. 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,

Eligibility 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

Primary outcomes:
measure: Determination of the level of concordance between EGFR mutation status obtained via tissue/cytology and blood (plasma) based testing.
timeFrame: From randomization until study completion, assessed up to 17 months
Secondary outcomes:
measure: Determination of the EGFR mutation frequency (including mutation subtypes) in patients with advanced NSCLC (aNSCLC) of adenocarcinoma and non-adenocarcinoma histologies.
timeFrame: From randomization until study completion, assessed up to 17 months.
measure: Describe the first line therapy choice following EGFR mutation testing.
timeFrame: From randomization until study completion, assessed up to 17 months.
measure: Describe the second line therapy choice following discontinuation of first line treatment for patients confirmed as EGFR mutation positive via tissue/cytology.
timeFrame: From randomization until study completion, assessed up to 17 months.
measure: 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.
timeFrame: From randomization until study completion, assessed up to 17 months.
measure: Determination of the correlation between EGFR mutation status from tumour and demographic data and disease status.
timeFrame: From randomization until study completion, assessed up to 17 months.
measure: Determination of the correlation between EGFR mutation status derived from plasma (blood) and demographic data and disease status.
timeFrame: From randomization until study completion, assessed up to 17 months.
Other outcomes:
Locations:
city: Compiegne
country: France
facility: Research Site
city: Gap
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Longjumeau
country: France
facility: Research Site
city: MEAUX Cedex
country: France
facility: Research Site
city: Saint-Brieuc
country: France
facility: Research Site
city: Saint-Michel
country: France
facility: Research Site
city: Saint-Quentin
country: France
facility: Research Site
city: Villefranche-sur-Saône Cedex
country: France
facility: Research Site
city: Berlin-Buch
country: Germany
facility: Research Site
city: Großhansdorf
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Karlsruhe
country: Germany
facility: Research Site
city: Löwenstein
country: Germany
facility: Research Site
city: Münnerstadt
country: Germany
facility: Research Site
city: Nürnberg
country: Germany
facility: Research Site
city: Solingen
country: Germany
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Bologna
country: Italy
facility: Research Site
city: Lecce
country: Italy
facility: Research Site
city: Monza
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Orbassano (TO)
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Hirakata
country: Japan
facility: Research Site
city: Iizuka
country: Japan
facility: Research Site
city: Kanazawa
country: Japan
facility: Research Site
city: Mibu
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Toyonaka
country: Japan
facility: Research Site
city: 's Hertogenbosch
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Bergen op Zoom
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Burgos
country: Spain
facility: Research Site
city: Cruces
country: Spain
facility: Research Site
city: Donostia
country: Spain
facility: Research Site
city: Leon
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Gävle
country: Sweden
facility: Research Site
city: Karlstad
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Rose McCormack, PhD
role: STUDY_DIRECTOR
References: