T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.

Detailed Description
-----------------
An observational, non-interventional, multi-central study of comparison of the frequency and abundance of T790M mutation using both amplification refractory mutation system (ARMS) and digital droplet PCR (ddPCR) methods among the different Clinical modes of non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) failure

Official Title
-----------------
Frequency and Abundance of T790M Mutation on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Treatment Failure: a Perspective Observational Study

Conditions
-----------------
Non-small Cell Lung Cancer Stage III, Non-Small-Cell Lung Cancer Metastatic

Intervention / Treatment
-----------------
* Other: mutation detection
* Other: ARMS and ddPCR
* Genetic: ctDNA analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed stage IIIB/IV NSCLC. Investigator confirmed progression according RECIST 1.1 during EGFR-TKI treatment within 28 days of the enrollment Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months Patient must be able to comply with the protocol Exclusion Criteria: Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined disease progression for more than 28 days while on previous EGFR-TKI treatment. Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment. Histologically confirmed small cell lung cancer or other metastatic tumors Patient with no histologic or cytological diagnosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: mutation detection|nan|
|Other: ARMS and ddPCR|nan|
|Genetic: ctDNA analysis|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay | The investigators will describe the number of T790M mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC) resistant to tyrosine kinase inhibitors (TKIs). | up to 2 years | 
| Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient | The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs. | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure | The investigators will describe the number of participants with T790M mutation in each different clinical mode of TKI failure by ARMS and ddPCR, and employ chi-square test to analyze the distribution of T790M mutation by ARMS and ddPCR in patients among the different Clinical modes of TKI failure. | up to 2 years | 
| Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure | The investigators will employ Analysis of Variance (ANOVA) method to analyze the differences of T790M mutation by ddPCR in patients among the different Clinical modes of TKI failure. | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
T790M, Non-small Cell Lung Cancer, circulating tumor DNA, amplification refractory mutation system, digital droplet PCR