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

NCT06167460 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-07-16

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Gene Solutions

    lead INDUSTRY

Principal Investigators

  • Sinh D Nguyen, PhD · MGI

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2025-11-01
Completion
2025-12-01

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06167460 on ClinicalTrials.gov