N/A
Completed N=314
T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure
Non-small Cell Lung Cancer Stage III · Non-Small-Cell Lung Cancer Metastatic
Source: ClinicalTrials.gov NCT02418234 ↗
Enrolled (actual)
314
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcomePrimary: Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay — 97 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay |
97 | — |
| PRIMARY Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient |
— | — |
| SECONDARY Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure |
49; 2; 46; 78; 7; 62 | <0.05 sig |
| SECONDARY Differences of T790M Mutation by ddPCR Among the Different Clinical Modes of TKI Failure |
0; 0; 0.56 | <0.05 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02418234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.