Trial Outcomes & Findings for T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure (NCT NCT02418234)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

314 participants

Primary outcome timeframe

up to 2 years

Results posted on

2018-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	TKI-PD Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
Overall Study STARTED	314
Overall Study COMPLETED	314
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TKI-PD n=314 Participants Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	177 Participants n=5 Participants
Sex: Female, Male Male	137 Participants n=5 Participants
Region of Enrollment China	314 participants n=5 Participants
Stage IIIA	54 participants n=5 Participants
Stage IIIB	21 participants n=5 Participants
Stage IV	239 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	TKI-PD n=314 Participants	Brain Limited 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 Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay	97 participants	—	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TKI-PD n=314 Participants	Brain Limited 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 Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient	0 percentage of total ctDNA Interval 0.0 to 70.3	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TKI-PD n=196 Participants	Brain Limited n=34 Participants 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 n=84 Participants Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure T790M positive by ARMS	49 participants	2 participants	46 participants
Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure T790M positive by ddPCR	78 participants	7 participants	62 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TKI-PD n=196 Participants	Brain Limited n=34 Participants 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 n=84 Participants Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure	0 percentage of total ctDNA Interval 0.0 to 34.61	0 percentage of total ctDNA Interval 0.0 to 13.07	0.56 percentage of total ctDNA Interval 0.0 to 70.3

Adverse Events

TKI-PD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Shenglin Ma

Hangzhou first people's hospital

Phone: 086057156007664

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place