Analysis of Whole Exome and Transcriptome Sequencing to Identify Prognostic Biomarkers in Patients With Non-Small Cell Lung Cancer (NSCLC)

Brief summary (registry, in English)

This is a non-interventional translational research study aiming to comprehensively characterize the genomic and transcriptomic landscape of patients with non-small cell lung cancer (NSCLC). The study will employ whole-exome sequencing (WES) and RNA sequencing (RNA-seq) on tumor tissue samples and matched germline DNA to identify genomic alterations, mutational signatures, and transcriptomic profiles associated with prognosis and response to immunotherapy. A total of approximately 300 patients with histologically confirmed NSCLC will be included, comprising both metastatic and early-stage disease. Formalin-fixed paraffin-embedded (FFPE) tumor tissue and, where available, fresh frozen samples will be analyzed. Peripheral blood samples will also be collected for germline DNA assessment. The study aims to identify clinically actionable genomic alterations, measure tumor mutational burden (TMB), characterize immune-related gene expression signatures, and investigate associations between molecular findings and clinical outcomes. In addition, a pilot sub-study will evaluate circulating tumor DNA (ctDNA) dynamics in approximately 20 patients with unresectable stage III NSCLC treated with concurrent chemoradiation followed by durvalumab maintenance therapy. Longitudinal plasma samples will be collected at predefined timepoints to assess minimal residual disease (MRD), ctDNA kinetics, and correlations with clinical outcomes including progression-free survival (PFS) and overall survival (OS). The results of this study are expected to improve understanding of tumor biology and immune landscape in NSCLC and support the identification of prognostic and predictive biomarkers for immunotherapy and other treatment strategies.

What you commit to

• Study type: Observational
• Planned participants: 300
• From 11 Dec 2021 to the primary completion date, 31 Dec 2026
• 18 sites in 2 countries
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

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