Overview

This trial is active, not recruiting.

Condition egfr mutation status in ansclc patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies.
Treatment egfr mutation test
Sponsor AstraZeneca
Start date February 2013
End date August 2014
Trial size 3500 participants
Trial identifier NCT01788163, D7913C00074

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
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)
egfr mutation test Determination of EGFR mutation done at the Pathology lab
EGFR mutation being tested in tissue and blood

Primary Outcomes

Measure
Determination of EGFR mutation frequency (including mutation subtypes) in patients with advanced NSCLC (aNSCLC) of adenocarcinoma and non-adenocarcinoma histologies
time frame: From randomization until study completion, assessed up to 17 months

Secondary Outcomes

Measure
Recording of first line therapy choice following EGFR mutation testing.
time frame: From randomization until study completion, assessed up to 17 months
Recording of second line therapy choice following discontinuation of first line treatment for patients confirmed as EGFR mutation positive via tissue/cytology
time frame: From randomization until study completion, assessed up to 17 months
Determination of the level of concordance between EGFR mutation status obtained via tissue/cytology and blood (plasma) based testing.
time frame: From randomization until study completion, assessed up to 17 months
Summarise of EGFR mutation testing practices
time frame: 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
time frame: 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
time frame: From randomization until study completion, assessed up to 17 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.