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

Non-small Cell Lung Cancer Stage III Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418234
• Other study ID #: HZFH CA15-02
• Status: Completed
• Phase: N/A
• First received: April 3, 2015
• Last updated: February 12, 2018
• Start date: March 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: November 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage III
• Non-Small-Cell Lung Cancer Metastatic

Intervention

Other:
• mutation detection

• ARMS and ddPCR

Genetic:
• ctDNA analysis

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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