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

A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing

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.

Study Overview

• Status: Completed
• Conditions: Locally Advanced or Metastatic EGFR(+) NSCLC Patients
• Intervention / Treatment: Procedure: genomic testing of T790M mutation

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 Type: Observational
• Enrollment (Actual): 897

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Research Site
  • Beijing, China, 100021
    • Research Site
  • Changchun, China, 130012
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Hangzhou, China, 310006
    • Research Site
  • Hangzhou, China, 310022
    • Research Site
  • Hangzhou, China, 310003
    • Research Site
  • Hangzhou, China, 310009
    • Research Site
  • Harbin, China, 150049
    • Research Site
  • Hefei, China, 230001
    • Research Site
  • Hohhot, China, 010017
    • Research Site
  • Ji Nan, China, 2501117
    • Research Site
  • Kunming, China, 650118
    • Research Site
  • Linhai, China, 317000
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 210029
    • Research Site
  • Qingdao, China, 266071
    • Research Site
  • Shanghai, China, 200032
    • Research Site
  • Shanghai, China, 200433
    • Research Site
  • Shenyang, China, 110001
    • Research Site
  • Shenzhen, China, 518020
    • Research Site
  • Urumqi, China, 830054
    • Research Site
  • Wuhan, China, 430022
    • Research Site
  • Wuhan, China, 430030
    • Research Site
  • Xi'An, China
    • Research Site
  • Xi'an, China, 710061
    • Research Site
  • Yantai, China, 264000
    • Research Site
  • Zhengzhou, China, 450008
    • Research Site
  • Ürümqi, China, 830000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
T790M mutation test; genomic testing of T790M mutation	Procedure: genomic testing of T790M mutation; patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence rate of T790M mutation based on the central lab testing	Prevalence (%) = (number of patients with T790M mutation positive)/(total number of patients in the FAS)×100%	within 1 -14 days after enrolled
The sensitivity of each platform based on the local lab plasma testing	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%	within 1 -14 days after enrolled
The Specificity of each platform based on the local lab plasma testing	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%	within 1 -14 days after enrolled
The Positive predictive value of each platform based on the local lab plasma testing	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%	within 1 -14 days after enrolled
The Negative predictive value of each platform based on the local lab plasma testing	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%	within 1 -14 days after enrolled
The Concordance of each platform based on the local lab testing	Concordance (%)=(number of patients with same T790M mutation status based on tissue and plasma tests)/(total number of patients in the FAS) ×100%	within 1 -14 days after enrolled
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	Prevalence (%) = (number of patients with C797S mutation positive)/(total number of patients with evaluable C797S testing)×100%	within 1 -14 days after enrolled
Rare EGFR mutation prevalence rate	Prevalence (%) = (number of patients with rare EGFR mutation positive)/(total number of patients in the FAS)×100%	within 1-14 days after enrolled

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Jie He, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2017
• Primary Completion (Actual): June 29, 2018
• Study Completion (Actual): June 29, 2018

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: December 9, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 12, 2019
• Last Update Submitted That Met QC Criteria: June 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: NSCLC; T790M; EGFR (Epidermal Growth Factor Receptor) mutation
• Other Study ID Numbers: D5160C00041

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No