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

NCT02418234 | Completed Results DMC

• 1 other identifier: HZFH CA15-02
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer Stage III; Non-Small-Cell Lung Cancer Metastatic

Keywords

Non-small Cell Lung Cancer; circulating tumor DNA; T790M; amplification refractory mutation system; digital droplet PCR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure

  up to 2 years

• Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure

  up to 2 years

Interventions

mutation detection OTHER

ARMS and ddPCR OTHER

ctDNA analysis GENETIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Non small cell lung cancer (NSCLC) after EGFR-TKI failure

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Prof. Shenglin Ma
• Organization: Hangzhou first people's hospital

mashenglin@medmail.com.cn

086057156007664

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2015
• First Posted: April 16, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: November 1, 2017
• Last Updated: March 12, 2018
• Results First Posted: August 8, 2016

Record last verified: 2018-01

Locations

CN (1)