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

July 12, 2025 updated by: Gene Solutions

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • Medical Genetics Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sinh D Nguyen, PhD. MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This study population will include female and male, aged 18 and older, who are diagnosed with stage IIIB-IV Non-small cell lung cancer and indicated for TKI or TKI combined with chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria to be recruited into this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between ctDNA dynamics and clinical response to TKI
Time Frame: 24 months following up.
  • No response/progressive disease = ctDNA levels increase from baseline
  • Partial response/stable disease = ctDNA levels decrease from baseline
  • Complete response = ctDNA clearance.
24 months following up.
To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
Time Frame: 24 months following up.
  • Correlation between ctDNA dynamics and clinical response
  • Correlation between RECIST1.1 and clinical response
  • Combination of ctDNA dynamics and RECIST v1.1 in the prognosis of clinical response.
24 months following up.
To investigate the relationship between ctDNA dynamics and progression free survival, overall survival.
Time Frame: 24 months following up.
  • Correlation between ctDNA dynamics and PFS
  • Correlation between ctDNA dynamics and OS.
24 months following up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gene Solutions

Investigators

  • Principal Investigator: Sinh D Nguyen, PHD, MGI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 21, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 12, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS_ZTKL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data of this this study may be requested for publication by the journals, sharing anonymized data with suitable study will be decided by the sponsor, PIs and the authority agency where the data was collected. No identifiable information will be shared with any other person/organization than authority in the study.

IPD Sharing Time Frame

December 2025.

IPD Sharing Access Criteria

GS_ZTKL for non-small cell lung cancer.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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