Leptomeningeal Metastases from Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group (Dose escalation stage):Using a "3+3" design, evaluate the efficacy of IT Ivoxidan at three dose levels (25mg, 50mg, 100mg).
Intrathecal treatment group (Dose Expansion Stage):Intrathecal Injection of Ivolizumab
Sponsors
Hangzhou Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed NSCLC with leptomeningeal metastasis (LM) (confirmed by positive CSF cytology or MRI). 2. Age >= 18 years. 3. ECOG performance status of 0-3. An ECOG status of 3 must be primarily attributable to leptomeningeal metastasis. 4. Prior receipt of at least one line of systemic therapy (including targeted therapy or immunotherapy). 5. Life expectancy >= 3 months. 6. Stable extracranial disease. 7. Presence of an Ommaya reservoir or suitability for lumbar puncture administration. 8. Patients may receive steroids for symptom control related to CNS involvement, but the dose must be = 4 mg/24h of dexamethasone (or equivalent). Physiological replacement doses for adrenal insufficiency are permitted per this protocol. 9. Important organ function is good: neutrophils >= 1.5 × 10 ?/L, platelets >= 75 × 10 ?/L; liver and kidney function is normal (ALT/AST <= 2.5 × ULN, Cr <= 1.5 × ULN).
Exclusion criteria
Exclusion criteria: 1. Active central nervous system infection or hemorrhage. 2. Uncontrolled intracranial hypertension (> 30 cmH2O). 3. Prior history of intrathecal immunotherapy. 4. Active autoimmune disease requiring immunosuppressive therapy. 5. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Tolerable Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;LM-PFS (Leptomeningeal Metastasis Progression-Free Survival); | — |
Countries
China
Contacts
Public ContactLucheng Zhu
Hangzhou Cancer Hospital
Outcome results
None listed