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

Completed

• Conditions: Locally Advanced or Metastatic EGFR(+) NSCLC Patients
• Interventions: Procedure: genomic testing of T790M mutation

• Registration Number: NCT02991274
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-12-09
• Study First Submitted QC: 2016-12-09
• Study First Posted: 2016-12-13
• Study Start: 2017-01-16
• Primary Completion: 2018-06-29
• Study Completion: 2018-06-29
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 897

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
T790M mutation test	genomic testing of T790M mutation	genomic testing of T790M mutation

Primary Outcome Measures

Name	Time	Method
the concordance of T790M mutation testing between the test in central and local labs	within 1 -14 days after enrolled	Concordance (%)=(number of patients with same T790M mutation status based on central and local labs)/(total number of patients in the FAS) ×100%

Secondary Outcome Measures

Name	Time	Method
The Positive predictive value of each platform based on the local lab plasma testing	within 1 -14 days after enrolled	Positive predictive value (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on plasma test) ×100%
The prevalence rate of T790M mutation based on the central lab testing	within 1 -14 days after enrolled	Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%
The sensitivity of each platform based on the local lab plasma testing	within 1 -14 days after enrolled	Sensitivity (%)=(number of patients with T790M mutation positive based on both tissue and plasma tests)/(number of patients with T790M mutation positive based on tissue test) ×100%
The Negative predictive value of each platform based on the local lab plasma testing	within 1 -14 days after enrolled	Negative predictive value (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on plasma test) ×100%
The prevalence of C797S (An amino acid substitution at position 797 in EGFR, from a Cysteine (C) to a Serine (S) ) resistance mutation based on the local lab testing	within 1 -14 days after enrolled	Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%
Rare EGFR mutation prevalence rate	within 1-14 days after enrolled	Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100%
The Specificity of each platform based on the local lab plasma testing	within 1 -14 days after enrolled	Specificity (%)=(number of patients with T790M mutation negative based on both tissue and plasma tests)/(number of patients with T790M mutation negative based on tissue test) ×100%
The Concordance of each platform based on the local lab testing	within 1 -14 days after enrolled	Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%

Trial Locations

Locations (1)

Research Site; 🇨🇳 Ürümqi, China