NCT06854939

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.

Prospective Observational Study Using Personalized Minimal Residual Disease Assay (Signatera) to Evaluate the Kinetics and Detection Rate in Patients with Non-small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: National Cancer Center, Japan · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC, Stage I, II, III

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-09-30
• Completion: 2029-09-30
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: Japan