Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer

What this Trial Is About

Researchers are investigating whether changes in circulating tumor DNA (ctDNA) measured by the K-TrackTM assay can predict how patients with advanced non-small cell lung cancer (NSCLC) respond early to tyrosine kinase inhibitors (TKIs). The study aims to understand the relationship between ctDNA levels and clinical response, compare ctDNA dynamics with standard imaging criteria (RECIST1.1), and explore associations with progression-free and overall survival. This observational study includes adult patients diagnosed with advanced NSCLC who are starting TKI treatment, with or without chemotherapy. Participants will have blood samples taken to analyze ctDNA at eight specific times: before starting TKI treatment (within 10 days) and then every three months during treatment for up to 21 months. Tumor tissue samples fixed in paraffin (FFPE) will also be collected before treatment. The study allows TKI combined with chemotherapy and follows patients for two years from enrollment, with CT scans performed at each clinical visit during this period. During the study, researchers will gather demographic, medical, and treatment information while monitoring ctDNA changes and imaging results to evaluate treatment response. Clinical visits include CT scans every few months and blood draws for ctDNA testing. The main outcomes measured over 24 months focus on how ctDNA changes relate to treatment response by TKI, imaging findings, and survival outcomes. Patient safety and adherence to the protocol are tracked throughout the two-year follow-up.

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