Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT06167460
Status:
RECRUITING
Last Update Posted:
2025-07-16
First Post:
2023-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.
Sponsor:
Gene Solutions
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: