drugset / Trial / NCT06901817
A Study of the Safety and Efficacy of Pemetrexed Combined with Nivolumab Via Intraventricular Injection for the Treatment of Refractory Non-squamous Non-small Cell Lung Cancer with Leptomeningeal Metastases
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to learn if the intraventricular injection of Pemetrexed and Nivolumab works to treat refractory non-squamous non-small cell lung cancer with leptomeningeal metastases. The main questions to answer are: * Is the combination of Pemetrexed and Nivolumab safe to inject? * How effective is the combination in disease control? Participants will: * Intrathecal injection of 30 mg pemetrexed via Ommaya reservoir, once every 4 weeks until disease progression; * Intrathecal injection of 40 mg nivolumab via Ommaya reservoir, once every 4 weeks until disease progression; * Before each intrathecal administration, a preliminary intrathecal injection of dexamethasone, 5 mg/2 mL, is given.
Timeline
- Start
- 2025-03-01
- Primary completion
- 2027-11
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 40 mg | Intrathecal |
| Subject | Pemetrexed | Small molecule | 30 mg | Intrathecal |
| Background | Dexamethasone | Small molecule | 5 mg | Intrathecal |