Clinical Trial

A Prospective Study Investigating the Relationship Between Minimal Residual Disease Detection, Monitoring Frequency, and Prognosis in Non-small Cell Lung Cancer Patients Eligible for Curative Treatment.

Study acronym: MRDSEEKER
Not Yet Recruiting
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Summary
Adding immune checkpoint inhibitors or molecularly targeted drugs as adjuvant therapy to curative treatments-such as surgery or chemoradiotherapy-for stage I-III non-small cell lung cancer (NSCLC) has been established as a standard of care and has improved treatment outcomes. However, there is currently no adequate method to determine which patients should receive these adjuvant therapies. Identifying those with a good prognosis without adjuvant therapy could reduce the risk of adverse events, lessen the burden of clinic visits, and reduce healthcare costs. Among various approaches, ctDNA-based MRD (minimal residual disease) analysis is highly anticipated and has already been introduced into clinical practice for hematologic malignancies. However, solid tumors' development as a companion diagnostic has been limited, and regulatory approval is mainly being considered based on performance evaluation data. In this study, we will conduct a performance evaluation of MRD analysis using Signatera™ in patients with stage I-III NSCLC while also collecting other prognostic factors based on clinicopathological information and survival data.
Trial Details
NCT Number NCT06854939
Lead Sponsor National Cancer Center, Japan
Collaborators: Natera, Inc.
Conditions NSCLC, Stage I, II, III
Enrollment 350 participants
Start Date 2025-03-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-03