Overview
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).
- 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.
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
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.