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

AstraZeneca

Status: Completed

Conditions: Locally Advanced or Metastatic EGFR(+) NSCLC Patients

Treatments: Procedure: genomic testing of T790M mutation

Study type: Observational

Funder types: Industry

Identifiers

NCT02991274

D5160C00041

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 897 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
2. Histological or cytological confirmed locally advanced NSCLC (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy.
3. Patients who have progressed following prior therapy with an EGFR-TKI agent.
4. Patients who consent to provide tumour tissue and/or blood.

Exclusion criteria

1. Patients who disagree to participate this study.
2. Patients whose medical objection was recorded to use the existing data from medical practice for scientific research.

Trial design

897 participants in 1 patient group

T790M mutation test

Description:

genomic testing of T790M mutation

Treatment:

Procedure: genomic testing of T790M mutation