Clinical trial · Observational
T790M Mutation on ctDNA in Patients With NSCLC After EGFR-TKI Failure
Frequency and Abundance of T790M Mutation on Circulating Tumor DNA in Patients With Non-small Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Treatment Failure: a Perspective Observational Study
NCT02418234CI-TRIAL-00032020completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare the frequency and abundance of T790M mutation among the different Clinical modes of EGFR-TKI failure.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Cancer Metastatic | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARMS and ddPCR | Other | — | UNRESOLVED |
| ctDNA analysis | Genetic | — | UNRESOLVED |
| mutation detection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of Patients With T790M Mutation Detected by Amplification Refractory Mutation System (ARMS) Assay
- timeFrame
- up to 2 years
- 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).
- measure
- Abundance of T790M Mutation Detected by Digital Droplet PCR (ddPCR) Assay in Each Individual Patient
- timeFrame
- up to 2 years
- description
- The investigators will describe the abundance of T790M mutation on ctDNA detected by ddPCR assay in patients with NSCLC resistant to TKIs.
Secondary outcomes (2)
- measure
- Number of T790M Mutation by ARMS and ddPCR Assays in Each Different Clinical Modes of TKI Failure
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.