Clinical trial · Observational
Liquid Biopsy Monitoring Of EGFR T790M in Advanced Non-Small Cell Lung Cancer
Longitudinal Liquid Biopsy Monitoring of EGFR T790M Resistance in Advanced Non-Small Cell Lung Cancer: Real-World Data From Tunisia
- 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 goal of this retrospective observational study is to assess the clinical utility of plasma-based EGFR testing for detection and longitudinal monitoring of the acquired T790M resistance mutation in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) treated with first- or second-generation EGFR tyrosine kinase inhibitors in routine clinical practice in Tunisia. The main questions it aims to answer are: * What is the detection rate of EGFR T790M mutation in plasma at the time of disease progression? * Does repeated liquid biopsy increase the cumulative detection of T790M? * Is T790M emergence associated with baseline clinical and molecular characteristics? * Is T790M status associated with progression-free survival? Participants underwent plasma sampling for circulating tumor DNA analysis during follow-up, and clinical and molecular data were retrospectively collected from medical records to evaluate mutation dynamics and outcomes.
Conditions
Conditions (1)
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Detection rate of EGFR T790M mutation in plasma at disease progression
- timeFrame
- From initiation of first- or second-generation EGFR-TKI therapy until the first documented radiological disease progression at which plasma EGFR T790M testing is performed, assessed up to 36 months.
- description
- Proportion of patients with detectable T790M in plasma at the time of radiological progression.
- measure
- Proportion of participants with newly detected EGFR T790M on repeat liquid biopsy after an initial negative plasma result
- timeFrame
- From the initial negative plasma EGFR T790M result at radiological disease progression until detection of T790M on repeat liquid biopsy testing during follow-up, assessed up to 36 months.
- description
- Incremental T790M detection rate in patients with initially negative plasma results who underwent additional testing.
Secondary outcomes (2)
- measure
- Association of T790M emergence with baseline characteristics
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Confirmed advanced (stage IIIB/IV) non-small cell lung cancer * Documented activating EGFR mutations * Disease progression on first- or second-generation EGFR TKIs Exclusion Criteria: * Prior treatment with third-generation EGFR TKIs before plasma sampling * Lack of follow-up clinical data
References
Publications (0)
Data not yet available