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.
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.
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.
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.
Cohort
Prospective
Not listed
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.
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.
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.
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