NCT06901817

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

Recruiting now Phase 2 Last updated 24 March 2025

What this trial tests

Phase 2 trial testing Intraventricular Pemetrexed in Leptomeningeal Metastasis in 97 participants. Currently enrolling.

Timeline

1 March 2025

Primary endpoint
1 November 2027

1 December 2027

Quick facts

Lead sponsor	Shanghai Cancer Hospital, China
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	97
Start date	1 March 2025
Primary completion	1 November 2027
Estimated completion	1 December 2027
Sites	1 location across China

Drugs / interventions tested

• Intraventricular Pemetrexed — full drug profile →
• Intraventricular Nivolumab — full drug profile →
• Intraventricular Dexamethasone — full drug profile →

Conditions studied

• Leptomeningeal Metastasis — all drugs for Leptomeningeal Metastasis →

Sponsor

Shanghai Cancer Hospital, China

Who can join

18 and older, any sex, with Leptomeningeal Metastasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Adverse Event
  Time frame: 30 days
  Per CTCAE version 4.0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatment options for EGFR mutation-positive NSCLC patients with leptomeningeal metastases after third-generation TKI resistance: a retrospective real-world study.
   Yun W, Liu A, Wen J, Zhao K, et al · · 2025 · PMID 41431726 · DOI 10.1177/17588359251403396