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

NCT06901817 ↗

Phase 2 Recruiting 97 enrolled Shanghai Cancer Hospital, China
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

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 40 mg Intrathecal
Subject Pemetrexed Small molecule 30 mg Intrathecal
Background Dexamethasone Small molecule 5 mg Intrathecal