ARTEMIS DIANE T790M (An Amino Acid Substitution at Position 790 in EGFR, From a Threonine (T) to a Methionine (M)) Mutation at Hospital Laboratories in Comparison With Central Laboratory

Study Overview
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Brief Summary
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The study primary objective is to assess the concordance of T790M resistance mutation testing from hospital-based laboratories with T790M resistance mutation testing from a central laboratory.

Detailed Description
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This is a multi-center testing study. 800 patients from 80 different hospital sites will have local T790M testing by different molecular testing platforms and have central testing by Cobas platform. These two sets of data (local T790M testing and central T790M testing) will be analysed and compared to assess the concordance of these T790M testing platforms.

Official Title
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A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing

Conditions
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Locally Advanced or Metastatic EGFR(+) NSCLC Patients

Intervention / Treatment
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* Procedure: genomic testing of T790M mutation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy. Patients who have progressed following prior therapy with an EGFR-TKI agent. Patients who consent to provide tumour tissue and/or blood. Exclusion Criteria: Patients who disagree to participate this study. Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| T790M mutation test<br>genomic testing of T790M mutation | Procedure: genomic testing of T790M mutation<br>* patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the concordance of T790M mutation testing between the test in central and local labs | Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100% | within 1 -14 days after enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence rate of T790M mutation based on the central lab testing | Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100% | within 1 -14 days after enrolled | 
| The sensitivity of each platform based on the local lab plasma testing | Sensitivity (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on tissue test) ×100% | within 1 -14 days after enrolled | 
| The Specificity of each platform based on the local lab plasma testing | Specificity (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on tissue test) ×100% | within 1 -14 days after enrolled | 
| The Positive predictive value of each platform based on the local lab plasma testing | Positive predictive value (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on plasma test) ×100% | within 1 -14 days after enrolled | 
| The Negative predictive value of each platform based on the local lab plasma testing | Negative predictive value (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on plasma test) ×100% | within 1 -14 days after enrolled | 
| The Concordance of each platform based on the local lab testing | Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100% | within 1 -14 days after enrolled | 
| The prevalence of C797S (An amino acid substitution at position 797 in EGFR, from a Cysteine (C) to a Serine (S) ) resistance mutation based on the local lab testing | Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100% | within 1 -14 days after enrolled | 
| Rare EGFR mutation prevalence rate | Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100% | within 1-14 days after enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T790M, EGFR (Epidermal Growth Factor Receptor) mutation, NSCLC