Actively Recruiting
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
Led by Shanghai Cancer Hospital, China · Updated on 2025-03-30
97
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing to sign informed consent and complete the study as per protocol
- Radiographic or cerebrospinal fluid confirmation of leptomeningeal disease with histological or cytological confirmation of non-small cell lung cancer
- ECOG performance status score of 2 or less
- Steroid use allowed if dose is 4 mg dexamethasone or equivalent or less within 24 hours, with stable neurological symptoms for at least 7 days or dose reduction ongoing
- Completed brain or spinal radiotherapy at least 7 days before starting treatment
- Allowed to continue approved systemic treatments chosen by researchers; no concurrent intrathecal drugs
- Minimum washout periods before study treatment: 7 days for intrathecal therapy, 14 days for chemotherapy, 14 days for investigational drugs, and 2 weeks for approved immunotherapy
- Age 18 years or older
- Able to provide written informed consent
- Adequate organ and bone marrow function
- No contraindications for Ommaya reservoir placement
- Refractory leptomeningeal metastasis defined by failed first- or second-generation TKI treatment with T790M mutation-negative, or failed third-generation TKI treatment, or EGFR mutation-negative and failed first-line treatment
You will not qualify if you...
- Need for ventriculoperitoneal (VP) shunt due to increased intracranial pressure
- Active autoimmune diseases requiring systemic treatment in past 2 years
- Systemic treatment including corticosteroids over 4 mg dexamethasone daily within 14 days prior to study drug administration
- Grade higher than 2 side effects from prior PD-1 or anti-CTLA-4 therapy
- Currently receiving experimental anti-cancer drugs (except approved targeted therapies)
- Participation in another clinical trial within 30 days prior to randomization
- Immunodeficiency or HIV infection
- Severe heart, lung, liver, or kidney dysfunction
- Uncontrolled or active infection
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
M
Min Fan, M.D.
CONTACT
J
Jiayan Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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