Spots Global Cancer Trial Database for Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC

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Trial Identification

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

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

Study ID: NCT05641870

Conditions

Lung Cancer

Stage III Lung Cancer

Unresectable Lung Carcinoma

Interventions

Sample collection

Characterization of the tumoral tissue genomic alterations

Chemoradiation treatment regimen and maintenance (if amenable)

Genomic and methylation analysis in liquid biopsy

Study Description

Brief Summary: 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.

Detailed Description: 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.