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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

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
Enrollment 314
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TKI-PD
Hide Arm/Group Description Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
Period Title: Overall Study
Started 314
Completed 314
Not Completed 0
Arm/Group Title TKI-PD
Hide Arm/Group Description Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment
Overall Number of Baseline Participants 314
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 314 participants
63
(32 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 314 participants
Female
177
  56.4%
Male
137
  43.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 314 participants
314
Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 314 participants
IIIA 54
IIIB 21
IV 239
[1]
Measure Description: Each patient was staged according to NCCN guidelines (2015. v6) at the time of enrollment. Generally, Stage IV showed worse prognosis.
1.Primary Outcome
Title Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay
Hide Description 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).
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TKI-PD
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 314
Measure Type: Number
Unit of Measure: participants
97
2.Primary Outcome
Title Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient
Hide Description The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TKI-PD
Hide Arm/Group Description:
Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
Overall Number of Participants Analyzed 314
Median (Full Range)
Unit of Measure: percentage of total ctDNA
0
(0 to 70.3)
3.Secondary Outcome
Title Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure
Hide Description 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.
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chest Limited Brain Limited Other Sites Failures
Hide Arm/Group Description:
Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
Overall Number of Participants Analyzed 196 34 84
Measure Type: Number
Unit of Measure: participants
T790M positive by ARMS 49 2 46
T790M positive by ddPCR 78 7 62
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chest Limited, Brain Limited, Other Sites Failures
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure
Hide Description 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.
Time Frame up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chest Limited Brain Limited Other Sites Failures
Hide Arm/Group Description:
Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
Overall Number of Participants Analyzed 196 34 84
Median (Full Range)
Unit of Measure: percentage of total ctDNA
0
(0 to 34.61)
0
(0 to 13.07)
0.56
(0 to 70.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chest Limited, Brain Limited, Other Sites Failures
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TKI-PD
Hide Arm/Group Description Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment.
All-Cause Mortality
TKI-PD
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TKI-PD
Affected / at Risk (%)
Total   0/314 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TKI-PD
Affected / at Risk (%)
Total   0/314 (0.00%) 
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
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