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

Completed

• Conditions: Non-Small-Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage III

• Registration Number: NCT02418234
• Lead Sponsor: First People's Hospital of Hangzhou

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

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-16
• Primary Completion: 2016-04
• Results First Submitted: 2016-05-19
• Results First Submitted QC: 2016-06-27
• Results First Posted: 2016-08-08
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay	up to 2 years	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).
Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient	up to 2 years	The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.

Secondary Outcome Measures

Name	Time	Method
Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure	up to 2 years	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.
Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure	up to 2 years	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.

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China