Clinical trial · Observational
EGFR Mutations on ctDNA in Patients With Advanced NSCLC
A Diagnostic Study to Determine the Prevalence of Epidermal Growth Factor Receptor Mutations Assessed With Circulating Tumor DNA Samples in Advanced Non-small Cell Lung Cancer
NCT02623257CI-TRIAL-00031649completedClinicalTrials.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 study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.
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 | Other | — | UNRESOLVED |
| ctDNA analysis | Genetic | — | UNRESOLVED |
| mutation detection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
- timeFrame
- up to 2 years
- description
- The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)
Secondary outcomes (3)
- measure
- Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics
- timeFrame
- up to 2 years
- description
- The investigators will employ chi-square test to analyze the distribution of EGFR mutation by ARMS in NSCLC patients among the different characteristics including smoking status, gender, age, PS score, and tumor stage
- measure
- Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay
- 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; * Patient had received ≤ 1 prior systemic chemotherapy regimens; * Provision of blood (plasma) sample for ctDNA testing; * Patient must be able to comply with the protocol; Exclusion Criteria: * Prior received ≥2 systemic chemotherapy regimens; * As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease); * 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.