NCT05457049

Adjuvant Therapy Omission for Resected NSCLC Patients With Longitudinal Undetectable MRD

Dynamic Observational Strategy for Stage IB-IIIA Non-Small Cell Lung Cancer Patients After Complete Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: Guangdong Association of Clinical Trials · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Molecular residual disease (MRD) has strong relationship with clinical outcome in multiple solid tumors. Here, the investigators try to verify the negative predictive value of undetectable MRD, which is considered as a superior prognostic factor for resected NSCLC patients, and not requiring excessive adjuvant therapy. Stage IB-IIIA resected NSCLC patients with landmark and longitudinal undetectable MRD are enrolled and under close surveillance in this study.

Detailed description

Stage IB-IIIA resected NSCLC patients will undergo two-round MRD tests after operation, first in 3-7 days and second in 1 month after operation. And patients who confirm two-round landmark undetectable MRD will be enrolled. Enrolled patients will be under close MRD and imaging monitoring without any adjuvant therapy.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Molecular residual disease test	OncoMRD Lung

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-08-01
• Completion: 2025-08-01
• First posted: 2022-07-13
• Last updated: 2022-09-29

Locations

1 site across 1 country: China