Clinical trial NCT02991274: 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
Official title: A Study of T790M Mutation Testing in Patient Tissue and Blood With Various Detection Platforms at Hospital Laboratories in Comparison With Central Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Locally Advanced or Metastatic EGFR(+) NSCLC Patients
Keywords: T790M
EGFR (Epidermal Growth Factor Receptor) mutation
NSCLC
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 897
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the concordance of T790M mutation testing between the test in central and local labs
timeFrame: within 1 -14 days after enrolled
Secondary outcomes:
measure: The prevalence rate of T790M mutation based on the central lab testing
timeFrame: within 1 -14 days after enrolled
measure: The sensitivity of each platform based on the local lab plasma testing
timeFrame: within 1 -14 days after enrolled
measure: The Specificity of each platform based on the local lab plasma testing
timeFrame: within 1 -14 days after enrolled
measure: The Positive predictive value of each platform based on the local lab plasma testing
timeFrame: within 1 -14 days after enrolled
measure: The Negative predictive value of each platform based on the local lab plasma testing
timeFrame: within 1 -14 days after enrolled
measure: The Concordance of each platform based on the local lab testing
timeFrame: within 1 -14 days after enrolled
measure: 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
timeFrame: within 1 -14 days after enrolled
measure: Rare EGFR mutation prevalence rate
timeFrame: within 1-14 days after enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Beijing
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Changchun
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Harbin
country: China
facility: Research Site
city: Hefei
country: China
facility: Research Site
city: Hohhot
country: China
facility: Research Site
city: Ji Nan
country: China
facility: Research Site
city: Kunming
country: China
facility: Research Site
city: Linhai
country: China
facility: Research Site
city: Nanchang
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Qingdao
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Shenzhen
country: China
facility: Research Site
city: Urumqi
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Wuhan
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
city: Xi'An
country: China
facility: Research Site
city: Yantai
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Ürümqi
country: China
facility: Research Site
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Caicun Zhou
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jie He
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jie Wang
role: PRINCIPAL_INVESTIGATOR
References: