Spots Global Cancer Trial Database for Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.

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Trial Identification

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

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

Study ID: NCT06167460

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

Interventions

Study Description

Brief 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.

Detailed Description: This study is recruiting female and male patients, aged 18 and older: * Who are diagnosed with advanced non-small cell lung cancer and indicated for TKI (first or second line). TKI combined with chemotherapy is allowed, * Who have not started TKI / chemotherapy before enrollment, * Who have no medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol, * FFPE/FNA sample is available, * Compliant with treatment protocol, * Patients consented to participate in the study. As part of the protocol, demographic data, medical and family history, and any relevant prior concomitant medication data will be recorded during follow-up visits. All patients are to be followed for 2 years from enrollment, with CT scan imaging measured every clinical visit for 24 months. Sample collection: * 10 mL of peripheral blood (in Streck tubes) is collected for ctDNA analysis at 8 time points: pre-treatment (\<10 days before TKI), during TKI every 3 months until 21 months. * 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before TKI/chemotherapy treatment.