Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.
Recruiting · NCT06167460 · Observational (researchers observe without assigning treatment) · Lead sponsor: Gene Solutions
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Patients are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed.
- FFPE/FNA sample is available.
- Compliant with treatment protocol.
- Patients consented to participate in the study.
Exclusion criteria
- Patients already started TKI before enrollment.
- Patients already started chemotherapy before enrollment.
- Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol.
- Patients did not agree to participate in the studies.
Where it is running
1 location listed.
- Medical Genetics Institute - Ho Chi Minh City, Vietnam