Clinical Trial

Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.

Recruiting
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Record status
This record was last updated July 16, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This is an observational study, aiming to investigate whether the ctDNA dynamics analyzed by the K-TrackTM assay could predict early response to Tyrosine kinase inhibitors (TKIs) in patients with advanced non-small cell lung cancer (NSCLC). 1. Determine relationship between ctDNA dynamics and clinical response to TKI, * No response/progressive disease = ctDNA levels increase from baseline * Partial response/stable disease = ctDNA levels decrease from baseline * Complete response = ctDNA clearance. 2. Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response. 3. Determine relationship between ctDNA dynamics and progression free survival, overall survival.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-12-04.
Trial Details
NCT Number NCT06167460
Lead Sponsor Gene Solutions
Conditions Non Small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IIIC Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Tyrosine Kinase Inhibitors
Enrollment 50 participants
Start Date 2023-12-04
Primary Completion 2025-11-01 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-16