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

Recruiting

• Conditions: Non Small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IIIC Non-Small Cell Lung Cancer; Tyrosine Kinase Inhibitors; Stage IV Non-small Cell Lung Cancer

• Registration Number: NCT06167460
• Lead Sponsor: Gene Solutions

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-21
• Study Start: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between ctDNA dynamics and clinical response to TKI	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.
To investigate the relationship between ctDNA dynamics and progression free survival, overall survival.	24 months following up.	* Correlation between ctDNA dynamics and PFS; * Correlation between ctDNA dynamics and OS.
To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.	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.

Trial Locations

Locations (1)

Medical Genetics Institute; 🇻🇳 Ho Chi Minh City, Vietnam