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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-11-30

Brief Summary

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The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.

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Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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mutation detection

Intervention Type OTHER

ARMS and ddPCR

Intervention Type OTHER

ctDNA analysis

Intervention Type GENETIC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No