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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02418234
Recruitment Status : Completed
First Posted : April 16, 2015
Results First Posted : August 8, 2016
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Stage III Non-Small-Cell Lung Cancer Metastatic Other: mutation detection Other: ARMS and ddPCR Genetic: ctDNA analysis

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

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Study Type : Observational
Actual Enrollment : 314 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay [ Time Frame: 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).

  2. Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient [ Time Frame: 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 :
  1. Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure [ Time Frame: 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.

  2. Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Non small cell lung cancer (NSCLC) after EGFR-TKI failure
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418234


Locations
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China, Zhejiang
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Sponsors and Collaborators
First People's Hospital of Hangzhou
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Responsible Party: First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT02418234    
Other Study ID Numbers: HZFH CA15-02
First Posted: April 16, 2015    Key Record Dates
Results First Posted: August 8, 2016
Last Update Posted: March 12, 2018
Last Verified: January 2018
Keywords provided by First People's Hospital of Hangzhou:
Non-small Cell Lung Cancer
circulating tumor DNA
T790M
amplification refractory mutation system
digital droplet PCR
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms