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

Sponsor
Shanghai Cancer Hospital, China
Study ID
NCT06901817
Phase
PHASE2
Status
Recruiting
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Conditions

  • Leptomeningeal Metastasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intraventricular Pemetrexed — DRUG
    Intraventricular injection of 30 mg pemetrexed via Ommaya reservoir, once every 4 weeks until disease progression.
  • Intraventricular Nivolumab — DRUG
    Intraventricular injection of 40 mg nivolumab via Ommaya reservoir, once every 4 weeks until disease progression.
  • Intraventricular Dexamethasone — DRUG
    Intraventricular injection of 5mg/2ml pemetrexed via Ommaya reservoir before injection of pemetrexed and nivolumab.

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Mar 2025
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
97 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intraventricular Pemetrexed combined with Nivolumab
    Patients with leptomeningeal metastases from refractory non-squamous non-small cell lung cancer will receive Pemetrexed and Nivolumab vis Ommaya reservoir.

Primary Outcome Measure

Adverse Event [ Time Frame: 30 days ]

Central Contacts

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