RecruitingPhase 2NCT06901817

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


Sponsor

Shanghai Cancer Hospital, China

Enrollment

97 participants

Start Date

Mar 1, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting chemotherapy drugs (pemetrexed) and an immunotherapy drug (nivolumab) directly into the fluid-filled spaces around the brain and spine can treat non-small cell lung cancer (non-squamous type) that has spread to the lining of the brain (leptomeningeal metastases). **You may be eligible if...** - You have confirmed non-small cell lung cancer with leptomeningeal disease (cancer spread to the brain/spine lining), confirmed by imaging or spinal fluid analysis - Your overall health status is ECOG 2 or better - Your neurological symptoms are stable - You are willing to undergo spinal fluid sampling (lumbar puncture) **You may NOT be eligible if...** - You have blockage of spinal fluid circulation in the brain - You have serious blood clotting problems or are on anticoagulants that cannot be adjusted - You have severe organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIntraventricular Pemetrexed

Intraventricular injection of 30 mg pemetrexed via Ommaya reservoir, once every 4 weeks until disease progression.

DRUGIntraventricular Nivolumab

Intraventricular injection of 40 mg nivolumab via Ommaya reservoir, once every 4 weeks until disease progression.

DRUGIntraventricular Dexamethasone

Intraventricular injection of 5mg/2ml pemetrexed via Ommaya reservoir before injection of pemetrexed and nivolumab.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06901817


Related Trials