Actively Recruiting
Study of Intraventricular Pemetrexed and Nivolumab Injection via Ommaya Reservoir for 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining Pemetrexed and Nivolumab injected into the brain ventricles to treat refractory non-squamous non-small cell lung cancer that has spread to the membranes surrounding the brain and spinal cord (leptomeningeal metastases). This Phase II study aims to determine if this treatment combination is safe and how well it controls the disease in patients who have already received prior treatments. Participants will receive intraventricular injections of 30 mg Pemetrexed and 40 mg Nivolumab through an implanted Ommaya reservoir every four weeks until their disease progresses. Before each treatment, a dose of dexamethasone is given intraventricularly to help manage inflammation. This treatment approach focuses on delivering drugs directly to the affected areas in the brain and spinal fluid. During the study, participants will be monitored for adverse events within 30 days and assessed for their disease response over one year. Researchers will evaluate the safety of the injections and measure how well the treatment controls the cancer. The study involves regular treatment visits spaced four weeks apart, and participants are observed until disease progression or other study endpoints. The trial is sponsored by Shanghai Cancer Hospital, China.
CONDITIONS
Brief 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 who sign the informed consent form and agree to follow the study protocol
- Confirmed diagnosis of non-small cell lung cancer with leptomeningeal disease by imaging or cerebrospinal fluid cytology
- ECOG performance status score of 2 or less
- Use of steroids allowed if dose is 4 mg dexamethasone (or equivalent) or less within 24 hours and neurological symptoms are stable or improving
- Completed brain or spinal radiotherapy at least 7 days before starting treatment
- May continue approved systemic treatments chosen by researchers but no other intrathecal therapies concurrently
- Last intrathecal treatment at least 7 days before study start
- Last systemic chemotherapy at least 14 days before study start
- Last approved systemic immunotherapy at least 2 weeks before study start
- Last investigational drug at least 14 days before study start
- Age 18 years or older
- Able to provide written informed consent
- Adequate organ and bone marrow function
- No contraindications to Ommaya reservoir placement
- Refractory leptomeningeal metastasis defined by failure of specific prior treatments
You will not qualify if you...
- Need for a ventriculoperitoneal (VP) shunt due to increased intracranial pressure
- Active autoimmune disease requiring systemic treatment within past 2 years
- Need for systemic treatment including corticosteroids over 4 mg dexamethasone equivalent within 14 days prior to study drug administration
- Previous PD-1 or anti-CTLA-4 therapy causing severe side effects greater than grade 2
- Currently receiving experimental anti-cancer drugs (approved targeted therapies allowed)
- History of other cancers unless disease-free for over 5 years or certain skin/cervical cancers
- Participation in another clinical trial with investigational drugs 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 4-week cycles until disease progression or discontinuation
Participants receive intraventricular injections of pemetrexed and nivolumab via Ommaya reservoir once every 4 weeks until disease progression.
Visits every 4 weeks for injections
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.
J
Jiayan Chen, M.D.
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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