Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to Tyrosine Kinase Inhibitors in Patients With Advanced Non-small Cell Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Gene Solutions
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Relationship between ctDNA dynamics and clinical response to TKI
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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).
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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.
-
Compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
-
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.
Investigators
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.
Outcomes
Primary Outcomes
Relationship between ctDNA dynamics and clinical response to TKI
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.