Sponsor: Tempus Labs, Inc
Sponsor Study ID: 103947
Study Title: TEMPUS GEMINI NSCLC STUDY: A Longitudinal Multi Omic Biomarker Profiling Study of Patients with Non Small Cell Lung Cancer (NSCLC)
CTO #: 103947
NCT Number: NCT05236114
Phase: N/A
Protocol Type: Diagnostic
Age Group: Adults
Disease Sites: Lung
Study Objectives: Primary Objectives: To prospectively determine if a plasma-only ctDNA methylation based minimum residual disease (MRD) assay (i.e., xM) completed one month post-surgical resection +/- adjuvant therapy can predict recurrence in patients with Stage I-IIIa NSCLC at a minimum of two year follow up. To prospectively determine if plasma-only ctDNA methylation based MRD assay (i.e., xM) completed one month post systemic therapy can predict recurrence or progression in patients with Stage IIIb-IV NSCLC at a minimum of one year follow up. Endpoints: Recurrence-Free Survival (RFS) or Progression-Free Survival (PFS) as assessed by standard radiographic imaging. Secondary Objectives: To determine the performance of a plasma-only ctDNA methylation-based MRD assay through serial testing To assess concordance between molecular biomarkers detected in the tumor tissue and in plasma ctDNA using a broad-based tissue and liquid NGS assays (i.e., xT and xF, respectively) To characterize test performance by disease stage. Endpoints: Sensitivity and specificity; RFS or PFS Percentage of variants detected by both assays Subgroup analysis of sensitivity and specificity by stage. Exploratory Objectives: To characterize the relationship between genomic results (xT, xF, xM) and clinical outcomes based on collection of longitudinal information from medical records To determine if surgical biopsy introduces ctDNA into the bloodstream To study tumor heterogeneity by comparing molecular results from biopsy and resection for patients with early-stage and locally advanced NSCLC. Endpoints: Clinical outcomes based on xT, xF, xM assay results Compare ctDNA detected before and after biopsy Variants detected from biopsy specimen vs. surgical resection specimen from the same patient