Asia Pacific and Russia Diagnostic Study for EGFR Testing

Not Applicable

Completed

Conditions: EGFR Mutation Status in aNSCLC Patients

Interventions: Genetic: EGFR mutation test

Registration Number: NCT01788163

Lead Sponsor: AstraZeneca

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3500

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Locally advanced/metastatic NSCLC pats.	EGFR mutation test	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)

Primary Outcome Measures

Name	Time	Method
Tumour EGFR Mutation Status by Histology	At Screening	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.
Overall Plasma EGFR Mutation Status	At Screening	Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.
Plasma EGFR Mutation by Subtype	At Screening	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.
Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status	At Screening	The 95% Confidence intervals were calculated using Clopper Pearson method for each country.
Tumour EGFR Mutation by Subtype	At Screening	Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
Plasma EGFR Mutation Status by Histology	At Screening	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

Secondary Outcome Measures

Name	Time	Method
Plasma EGFR Mutation Testing	At Screening	Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.
Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples	At Screening	Plasma samples were only performed in China, Taiwan, South Korea and Russia.
Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples	At Screening	Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.
Tumour EGFR Mutation Testing	At Screening	Frequencies of tumour EGFR mutation testing practices parameters.
Plasma EGFR Mutation Testing Rates	At Screening	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 Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation	At Screening	Number of months since the first diagnosis of NSCLC from informed consent date.
Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples	At Screening	Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.
Tumour EGFR Mutation Testing Turnaround Time	At Screening	Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.
Demographics and Disease Characteristics by Plasma EGFR Mutation Status	At Screening	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.
First Line Treatment Choice by Asia Pacific Country	At Screening
Demographics and Disease Characteristics by Tumour EGFR Mutation Status	At Screening	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.
Tumour EGFR Mutation Testing Rates	At Screening	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.
Number of Organs With Metastasis by Tumour EGFR Mutation Status	At Screening	Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.
Plasma EGFR Mutation Testing Turnaround Time	At Screening	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.
Number of Organs With Metastasis by Plasma EGFR Mutation Status	At Screening	Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status	At Screening
Time Since First NSCLC Diagnosis by Plasma EGFR Mutation	At Screening	Number of months since the first diagnosis of NSCLC from informed consent date.