Europe-Japan Diagnostic Study for EGFR Testing

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

Official Title
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A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Locally advanced/metastatic NSCLC pts.<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the level of concordance between EGFR mutation status obtained via tissue/cytology and blood (plasma) based testing. |  | From randomization until study completion, assessed up to 17 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the EGFR mutation frequency (including mutation subtypes) in patients with advanced NSCLC (aNSCLC) of adenocarcinoma and non-adenocarcinoma histologies. |  | From randomization until study completion, assessed up to 17 months. | 
| Describe the first line therapy choice following EGFR mutation testing. |  | 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. |  | 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. |  | 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. |  | 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. |  | From randomization until study completion, assessed up to 17 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGFR,, aNSCLC,, mutation status,, diagnostic study,, Europe,, Japan