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
A Multicenter, Prospective, Phase II Study on Intraventricular Injection of Pemetrexed Combined with Nivolumab Via an Ommaya Reservoir for the Treatment of Refractory Non-squamous Non-small Cell Lung Cancer (NSCLC) with Leptomeningeal Metastases in Previously Treated Patients
Shanghai Cancer Hospital, China
97 participants
Mar 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Intraventricular injection of 30 mg pemetrexed via Ommaya reservoir, once every 4 weeks until disease progression.
Intraventricular injection of 40 mg nivolumab via Ommaya reservoir, once every 4 weeks until disease progression.
Intraventricular injection of 5mg/2ml pemetrexed via Ommaya reservoir before injection of pemetrexed and nivolumab.
Locations(1)
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NCT06901817