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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167460
• Other study ID #: GS_ZTKL
• Status: Recruiting
• Start date: December 4, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2023
• Source: Gene Solutions
• Contact: Lan NL Tu, PhD
• Phone: +84888843489
• Email: lantu[@]genesolutions.vn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Locations

Country	Name	City	State
Vietnam	Medical Genetics Institute	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Gene Solutions

Country where clinical trial is conducted

Vietnam, 

References & Publications (15)

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* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.