Clinical Trial

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

Recruiting Phase 2
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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.
Trial Details
NCT Number NCT06901817
Lead Sponsor Shanghai Cancer Hospital, China
Conditions Leptomeningeal Metastasis
Enrollment 97 participants
Start Date 2025-03-01
Primary Completion 2027-11 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-30