Actively Recruiting
Immune Checkpoint Inhibitors Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
Led by West China Hospital · Updated on 2026-05-12
17
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-arm, open clinical study, which was designed to evaluate the efficacy and safety of an immune checkpoint inhibitor combined with pemetrexed intrathecal injection in the treatment of patients with NSCLC associated with leptomeningeal metastases.
CONDITIONS
Official Title
Immune Checkpoint Inhibitors Intrathecal Injection in Patients With Leptomeningeal Metastases in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years old, male or female
- Pathologically diagnosed non-small cell lung cancer with cerebrospinal fluid and/or MRI diagnosis of leptomeningeal metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 4
- Expected survival time of at least 4 weeks
- Oncologist confirmation of possible need for systemic therapy for metastatic tumors outside the CNS
- Previous radiation therapy completed at least 7 days before treatment start
- Allowed to continue approved targeted therapies and other systemic therapies; no concurrent intrathecal therapy with other agents
- Laboratory tests meeting criteria for bone marrow, renal, liver, and coagulation function
- Females of child-bearing potential and males agree to use contraception during study and 6 months after; females must have a negative pregnancy test and not be breastfeeding
- No participation in another drug clinical trial within 4 weeks prior to enrollment
- Able to understand the study and voluntarily sign informed consent
- Expected to comply with follow-up and protocol requirements
You will not qualify if you...
- Diagnosis of other malignant tumors within the past 5 years (except carcinoma in situ, basal cell carcinoma, etc.)
- History of allergy to pemetrexed or immune checkpoint inhibitors
- Any previous intrathecal injection therapy
- Exclusion of other meningitis types (aseptic, viral, bacterial)
- Participation in other clinical trials or observation periods
- Conditions interfering with safety evaluation, informed consent, or protocol compliance
- Treatment-related toxicity from prior systemic therapy above CTCAE grade 1 except alopecia
- Active or history of autoimmune disease, immunodeficiency, active tuberculosis, hepatitis B or C infection
- Disease or treatment causing permanent immunosuppression
- Active infection or serious comorbidities
- Uncontrolled epilepsy or severe neurological impairment related to treatment
- Hereditary or acquired bleeding or clotting disorders
- Severe injury or surgery within 1 month before enrollment
- Use of live or attenuated vaccines within 30 days before first dose (except injectable flu vaccine)
- Inability to complete enhanced MRI
- Use of immunosuppressive drugs or corticosteroids >10 mg prednisone equivalent within 14 days before enrollment except low dose dexamethasone for CNS symptoms
- Investigator judgment deeming participant unsuitable for enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
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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