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

NCT06167460 | Recruiting

• 1 other identifier: GS_ZTKL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

• No response/progressive disease = ctDNA levels increase from baseline
• Partial response/stable disease = ctDNA levels decrease from baseline
• Complete response = ctDNA clearance.
• Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
• 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

Keywords

Liquid Biopsy; Circulating Tumour DNA; Vietnam

Outcome Measures

Primary Outcomes (3)

• 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.

  24 months following up.

• To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.

  * 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.

  * Correlation between ctDNA dynamics and PFS * Correlation between ctDNA dynamics and OS.

  24 months following up.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gene Solutions: lead

Study Sites (1)

Medical Genetics Institute

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (15)

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Biospecimen

Retention: SAMPLES WITH DNA

The 1st blood sample is collected from eligible participants of non-small cell lung cancer, stage IIIB-IV, before TKI and chemotherapy. The 2nd -8th blood sample are collected from the participants every 3 months during TKI treatment, 6-8 sections of formalin-fixed paraffin-embedded (FFPE) tumor samples before TKI and chemotherapy are also collected.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sinh D Nguyen, PhD

  MGI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lan NL Tu, PhD

CONTACT

+84888843489; lantu@genesolutions.vn

VAN T Phan, MSc

CONTACT

+84908145990; vanphan@genesolutions.vn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 12, 2023
• Study Start: December 4, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: December 2025.
• Access Criteria: GS\ ZTKL for non-small cell lung cancer.

Locations

VN (1)