ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Non-small Cell Lung Cancer Stage III
Non-Small-Cell Lung Cancer Metastatic
Interventions: Other: mutation detection
Other: ARMS and ddPCR
Genetic: ctDNA analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TKI-PD Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment

Participant Flow:   Overall Study
    TKI-PD
STARTED   314 
COMPLETED   314 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TKI-PD Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment

Baseline Measures
   TKI-PD 
Overall Participants Analyzed 
[Units: Participants]
 314 
Age 
[Units: Years]
Median (Full Range)
 63 
 (32 to 89) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      177  56.4% 
Male      137  43.6% 
Region of Enrollment 
[Units: Participants]
 
China   314 
Stage [1] 
[Units: Participants]
 
IIIA   54 
IIIB   21 
IV   239 
[1] Each patient was staged according to NCCN guidelines (2015. v6) at the time of enrollment. Generally, Stage IV showed worse prognosis.


  Outcome Measures

1.  Primary:   Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay   [ Time Frame: up to 2 years ]

2.  Primary:   Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient   [ Time Frame: up to 2 years ]

3.  Secondary:   Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure   [ Time Frame: up to 2 years ]

4.  Secondary:   Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure   [ Time Frame: up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof. Shenglin Ma
Organization: Hangzhou first people's hospital
phone: 086057156007664
e-mail: mashenglin@medmail.com.cn



Responsible Party: First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT02418234     History of Changes
Other Study ID Numbers: HZFH CA15-02
First Submitted: April 3, 2015
First Posted: April 16, 2015
Results First Submitted: May 19, 2016
Results First Posted: August 8, 2016
Last Update Posted: March 12, 2018