drugset / Trial / NCT07375316
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
EGFR-mutated advanced NSCLC patients without ctDNA clearance after lead-in osimertinib monotherapy have inferior PFS compared with those with ctDNA clearance. Consequently, these patients might need an intensified therapeutic strategy, such as osimertinib combined with chemotherapy or ADC. This study aims to explore the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy.
Timeline
- Start
- 2025-12-15
- Primary completion
- 2028-06-30
- Completion
- 2028-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Osimertinib | Small molecule | 80 mg | Oral |
| Subject | Sacituzumab Tirumotecan | Other / unclassified | 4 mg/m2 | Intravenous |
| Subject | Sacituzumab Tirumotecan | Other / unclassified | 4 mg/kg | Intravenous |