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

NCT ID: NCT06167460

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-04
• Study Completion Date: 2025-12-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gene Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sinh D Nguyen, PhD

Role: PRINCIPAL_INVESTIGATOR

MGI

Locations

Medical Genetics Institute

Ho Chi Minh City, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Lan NL Tu, PhD

Role: CONTACT

lantu@genesolutions.vn

+84888843489

VAN T Phan, MSc

Role: CONTACT

vanphan@genesolutions.vn

+84908145990

Facility Contacts

Lan D Nguyen, PhD

Role: primary

lantu@genesolutions.vn

+84888843489

VAN T Le, PhD

Role: backup

vanphan@genesolutions.vn

+84908145990

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Other Identifiers

GS_ZTKL

Identifier Type: -

Identifier Source: org_study_id