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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Leptomeningeal Metastasis

Interventions

DRUG

Intraventricular Pemetrexed

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

DRUG

Intraventricular Nivolumab

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

DRUG

Intraventricular Dexamethasone

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

Sponsors & Collaborators

  • Shanghai Cancer Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-11-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06901817 on ClinicalTrials.gov