RecruitingNCT06167460

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

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

Sponsor

Gene Solutions

Enrollment

50 participants

Start Date

Dec 4, 2023

Study Type

OBSERVATIONAL

Conditions

Non-small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer Tyrosine Kinase Inhibitors Stage IIIb Non-small Cell Lung Cancer Stage IIIC Non-Small Cell Lung Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether small fragments of tumor DNA circulating in the blood can help predict and track how well targeted therapy (called TKI — drugs that block signals that help cancer grow) is working in patients with advanced lung cancer. **You may be eligible if...** - You have been diagnosed with advanced non-small cell lung cancer - Your doctor has recommended a TKI (targeted therapy) as your first or second treatment - A tissue or fluid sample from your tumor is available for testing - You have not yet started TKI or chemotherapy **You may NOT be eligible if...** - You have already started TKI treatment before enrolling - You have already started chemotherapy before enrolling - You have medical or psychiatric conditions that would prevent you from following the study plan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Medical Genetics Institute

Ho Chi Minh City, Vietnam

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NCT06167460

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