drugset / Trial / NCT06709274
Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC
Not yet recruiting
342 enrolled
Guangdong Association of Clinical Trials
Nanjing Geneseeq Technology Inc. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This investigator-initiated study aims to evaluate the effectiveness of minimal residual disease (MRD) as a biomarker for guiding adjuvant therapy decisions in patients with Stage I non-small-cell lung cancer (NSCLC). The study will compare outcomes between an MRD-guided management group and a standard-of-care group, focusing on whether the use of MRD information can improve the 3-year disease-free survival rate compared to existing treatment protocols. Participants in the MRD-guided management group will receive targeted therapy, immunotherapy, or observation based on their postoperative MRD status, while those in the standard-of-care group will receive treatments or observation according to current clinical guidelines.
Timeline
- Start
- 2024-11
- Primary completion
- 2029-01
- Completion
- 2032-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alectinib | Small molecule | 600 mg | — |
| Subject | Osimertinib | Small molecule | 80 mg | — |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | — |