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

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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

Tracking Information
First Submitted Date April 3, 2015
First Posted Date April 16, 2015
Results First Submitted Date May 19, 2016
Results First Posted Date August 8, 2016
Last Update Posted Date March 12, 2018
Actual Study Start Date March 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2016)
  • 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).
  • 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.
Original Primary Outcome Measures
 (submitted: April 13, 2015)
  • Proportion of patients with T790M mutation detected by amplification refractory mutation system (ARMS) assay [ Time Frame: up to 2 years ]
    We will describe the proportion 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 [ Time Frame: up to 2 years ]
    We will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.
Change History
Current Secondary Outcome Measures
 (submitted: June 27, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: April 13, 2015)
  • Distribution of T790M mutation by ARMS and ddPCR assays among the different Clinical modes of TKI failure [ Time Frame: up to 2 years ]
    We will 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 [ Time Frame: up to 2 years ]
    We 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title T790M Mutation on ctDNA in Patients With NSCLC After 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
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Non small cell lung cancer (NSCLC) after EGFR-TKI failure
Condition
  • Non-small Cell Lung Cancer Stage III
  • Non-Small-Cell Lung Cancer Metastatic
Intervention
  • Other: mutation detection
  • Other: ARMS and ddPCR
  • Genetic: ctDNA analysis
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2016)
314
Original Estimated Enrollment
 (submitted: April 13, 2015)
300
Actual Study Completion Date November 2017
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02418234
Other Study ID Numbers HZFH CA15-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party First People's Hospital of Hangzhou
Study Sponsor First People's Hospital of Hangzhou
Collaborators Not Provided
Investigators Not Provided
PRS Account First People's Hospital of Hangzhou
Verification Date January 2018