Clinical trial NCT06167460: Analysis of Circulating Tumor DNA Dynamics to Predict and Monitor Response to TKI in Patients With Advanced NSCLC.
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Keywords: Liquid Biopsy
Circulating Tumour DNA
Vietnam
Lead sponsor: Gene Solutions
Sponsor class: INDUSTRY
First posted: 2023-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study population will include female and male, aged 18 and older, who are diagnosed with stage IIIB-IV Non-small cell lung cancer and indicated for TKI or TKI combined with chemotherapy. Eligible participants will meet all of the inclusion and exclusion criteria to be recruited into this study.

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.

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.

Primary outcomes:
measure: Relationship between ctDNA dynamics and clinical response to TKI
timeFrame: 24 months following up.
measure: To compare and combine ctDNA dynamics and RECIST1.1 to predict clinical response.
timeFrame: 24 months following up.
measure: To investigate the relationship between ctDNA dynamics and progression free survival, overall survival.
timeFrame: 24 months following up.
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Medical Genetics Institute
Study officials:
affiliation: MGI
name: Sinh D Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
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