Asia Pacific and Russia Diagnostic Study for EGFR Testing

Study Overview
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Brief Summary
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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. It will be conducted in Asia Pacific and Russia and will assess the current status of EGFR mutation testing, and the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA.

Detailed Description
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A diagnostic study to determine the prevalence of EGFR mutations in Asian and Russian patients with advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma histologies

Official Title
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A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies

Conditions
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EGFR Mutation Status in aNSCLC Patients

Intervention / Treatment
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* Genetic: EGFR mutation test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Naive (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 (surgical specimen, biopsy sample, or cytology sample is acceptable) and Provision of a routine blood (plasma) sample in China, Russia, Taiwan and Korea Patients aged 18 years and older Exclusion Criteria: As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal 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

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Locally advanced/metastatic NSCLC pats.<br>Patients 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) | Genetic: EGFR mutation test<br>* EGFR mutation being tested in tissue and blood<br>* Other names: Determination of EGFR mutation done at the Pathology lab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status | The 95% Confidence intervals were calculated using Clopper Pearson method for each country. | At Screening | 
| Tumour EGFR Mutation by Subtype | Frequency distribution of subjects with a positive mutation status by the mutation subtype and country. | At Screening | 
| Tumour EGFR Mutation Status by Histology | Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country. | At Screening | 
| Overall Plasma EGFR Mutation Status | Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country. | At Screening | 
| Plasma EGFR Mutation by Subtype | Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country. | At Screening | 
| Plasma EGFR Mutation Status by Histology | Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country | At Screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples | Plasma samples were only performed in China, Taiwan, South Korea and Russia. | At Screening | 
| Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples | Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed. | At Screening | 
| Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples | Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed. | At Screening | 
| Tumour EGFR Mutation Testing | Frequencies of tumour EGFR mutation testing practices parameters. | At Screening | 
| Tumour EGFR Mutation Testing Rates | Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. | At Screening | 
| Tumour EGFR Mutation Testing Turnaround Time | Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result. | At Screening | 
| Plasma EGFR Mutation Testing | Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters. | At Screening | 
| Plasma EGFR Mutation Testing Rates | Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia. | At Screening | 
| Plasma EGFR Mutation Testing Turnaround Time | Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result. | At Screening | 
| Demographics and Disease Characteristics by Tumour EGFR Mutation Status | Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry. | At Screening | 
| Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation | Number of months since the first diagnosis of NSCLC from informed consent date. | At Screening | 
| Number of Organs With Metastasis by Tumour EGFR Mutation Status | Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included. | At Screening | 
| Demographics and Disease Characteristics by Plasma EGFR Mutation Status | Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry. | At Screening | 
| Time Since First NSCLC Diagnosis by Plasma EGFR Mutation | Number of months since the first diagnosis of NSCLC from informed consent date. | At Screening | 
| Number of Organs With Metastasis by Plasma EGFR Mutation Status | Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included. | At Screening | 
| First Line Treatment Choice by Asia Pacific Country |  | At Screening | 
| First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status |  | At Screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aNSCLC, mutation status, diagnostic study, Russia, China, Asia, EGFR