EGFR Gene Mutation, Non Small Cell Lung Cancer
Conditions
Keywords
Carcinoma, Non-Small-Cell Lung, EGFR Genes, Bronchoscopy, Liquid biopsy, T790M
Brief summary
The purpose of this study is to evaluate the relevance of intratumoral washing for detection of EGFR mutation (including T790M positivity).
Detailed description
This is a prospective, single-arm, open-label study to assess evaluate the relevance of intratumoral washing by ultrathin bronchoscopy (outer diameter; 3mm) for detection of EGFR mutation (including T790M positivity) using cobas real-time PCR and droplet digital PCR (DDPCR) in patients with NSCLC.
Interventions
DIAGNOSTIC_TESTUltarthin bronchoscopy with intratumoral washing
Each subject with NSCLC will undergo bronchooscopic procedure. First, ultrathin bronchoscope is inserted and placed within tumor under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance. Then, intratumoral washing is performed. Subsequently, transbronchial lung biopsy is performed under radial EBUS, virtual bronchoscopic navigation, and fluoroscopy guidance.
Sponsors
Pusan National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 20 years * Obtained written informed consent * Patients diagnosed with NSCLC by histology or cytology and inoperable stage IV at the time of study enrollment * Patients with the following EGFR gene mutations: E19Del, L858R alone or concurrent rare EGFR gene mutations (T790M, G719X, exon 20 insertion, S768I) * Patients previously treated with EGFR-TKIs such as gefitinib, erlotinib, afatinib, dacomitinib as first line therapy * Patients who had shown clinical benefits (CR, PR, SD) from EGFR-TKIs and had been confirmed PD on those therapy according to RECIST v 1.1. * Patients who underwent liquid biopsy (plasma) for EGFR mutation at the time of PD on EGFR-TKIs * Patients who plan to undergo tissue biopsy for EGFR mutation at the time of PD on EGFR-TKIs
Exclusion criteria
* Patients who withdraw informed consent * Patients who are unable to undergo liquid biopsy (plasma) and tissue biopsy for EGFR mutation based on the investigator's judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The DNA and EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid | through study completion, an average of 1 year | Defined as the number of DNA and EGFR mutation (including T790M positivity) detection divided by the total attempts of intratumoral washing by ultrathin bronchoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The concordance rate of EGFR mutation (including T790M positivity) detection rate among intratumoral washing fluid, plasma, and tissue | through study completion, an average of 1 year | The concordance rate of EGFR mutation (including T790M positivity) detection rate in intratumoral washing fluid, compared with plasma and tissue (gold standard). |
| The EGFR mutation (including T790M positivity) sensitivity and specificity in intratumoral washing fluid | through study completion, an average of 1 year | The sensitivity and specificity of EGFR mutation (including T790M positivity) in intratumoral washing fluid compared with tissue (gold standard). |
| Objective response rate | through study completion, an average of 1 year | Objective response rate (ORR) including rate of complete response (CR) and partial response (PR) based on RECIST 1.1. |
| Disease control rate | through study completion, an average of 1 year | Disease control rate (DCR) including rate of CR, PR and stable disease (SD) based on RECIST 1.1. |
| Progression-free survival | through study completion, an average of 1 year | Progression-free survival (PFS) the time from first dose of the study drug until the date of progressive disease (PD) based on RECIST 1.1 or death by any cause. |
Countries
South Korea
Outcome results
None listed