Asia Pacific and Russia Diagnostic Study for EGFR Testing

AstraZeneca3,500 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

3,500

Conditions

EGFR Mutation Status in aNSCLC Patients

Interventions

EGFR mutation testGENETIC

EGFR mutation being tested in tissue and blood

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (71)

Outcomes

Primary Outcomes

Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status

The 95% Confidence intervals were calculated using Clopper Pearson method for each country.

Time frame: At Screening

Tumour EGFR Mutation by Subtype

Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: At Screening

Secondary Outcomes

Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Research Site

Campbelltown, New South Wales, Australia

Research Site

Coffs Harbour, New South Wales, Australia

Research Site

Concord, New South Wales, Australia

Research Site

Tamworth, New South Wales, Australia

Research Site

Tweed Heads, New South Wales, Australia

Research Site

Wahroonga, New South Wales, Australia

Research Site

Brisbane, Queensland, Australia

Research Site

Woolloongabba, Queensland, Australia

Research Site

Murdoch, Western Australia, Australia

Research Site

Beijing, China

...and 61 more locations

Plasma samples were only performed in China, Taiwan, South Korea and Russia.

Time frame: 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.

Time frame: 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.

Time frame: At Screening

Tumour EGFR Mutation Testing

Frequencies of tumour EGFR mutation testing practices parameters.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: At Screening

Demographics and Disease Characteristics by Plasma EGFR Mutation Status

Time frame: At Screening

Time Since First NSCLC Diagnosis by Plasma EGFR Mutation

Number of months since the first diagnosis of NSCLC from informed consent date.

Time frame: 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.

Time frame: At Screening

First Line Treatment Choice by Asia Pacific Country

Time frame: At Screening

First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status

Time frame: At Screening