Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC

Molecular Profiling and Dynamic Changes of Circulating Tumor DNA in Unresectable Locally Advanced Non-small Cell Lung Cancer

Multi-center observational clinical study to evaluate the application value of ctDNA monitoring in efficacy assessment and relapse prediction in patients diagnosed with unresectable, locally advanced NSCLC receiving CRT with or without durvalumab maintenance treatment.

Newly diagnosed, histologically confirmed, unresectable stage III NSCLC patients, amenable to receive standard of care chemoradiotherapy with or without durvalumab maintenance, will be enrolled in this study. Whole blood collection will be conducted during the treatment for ctDNA detection in specific time-points of interest. Next-generation sequencing using commercially available panels, and analysis of ctDNA aberrant methylation will be performed. Results will be correlated to patients' recurrence times and survival outcomes.

Inclusion Criteria:

• Patients with newly diagnosed, histologically confirmed, unresectable locally advanced NSCLC.
• ≥18 years of age.
• Ability to understand the written informed consent and willingness to sign it.

Exclusion Criteria:

• Patients who are unwilling to follow-up evaluation of response to therapy.
• Any condition that, in the opinion of the investigator, would interfere with study results.