Locally Advanced or Metastatic EGFR(+) NSCLC Patients
Conditions
Keywords
T790M, EGFR (Epidermal Growth Factor Receptor) mutation, NSCLC
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.
Interventions
PROCEDUREgenomic testing of T790M mutation
patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.
Sponsors
AstraZeneca
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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% |
| 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 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% |
Countries
China
Outcome results
None listed