NSCLC with refractory leptomeningeal metastasis
Conditions
Interventions
Experimental group:Pemetrexed intrathecal injection
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. ECOG PS 0-4; 3. NSCLC patients with meningeal metastasis according to the EANO–ESMO clinical practice guidelines; 4. Multiline treatment failure, including systemic chemotherapy, tyrosine kinase inhibitor (TKI) treatment, intrathecal chemotherapy with MTX and cytarabine, immunotherapy, or whole-brain radiation therapy; 5. Adequate organ function (absolute neutrophil count >= 1500 /mm3, platelet count >= 70,000 /mm3, hemoglobin concentration >= 7.0 g/dL, serum total bilirubin concentration = 90% on room air, and proteinuria <= 1+); 6.Diagnosed as refractory leptomeningeal metastasis: (1) For patients with actionable mutations, diagnosis of LM during systemic therapy with tyrosinekinase inhibitors (TKIs) or progression of known LM on treatment with TKIs; (2) For patients with EGFR Thr790Met (T790M) mutation or anaplastic lymphoma kinase (ALK) positive NSCLC, LM progression after failure of third generation EGFR-TKIs or second/third generation ALK inhibitors; for patients without EGFR T790M mutation, LM progression after failure of first/second/third generation EGFR-TKIs; (3) Diagnosis of LM in wild-type patients after first-line standard treatment failure; 7. Subjects who understand and are willing to sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. HIV-positive patients; 2. History of severe pemetrexed allergies; 3. Severe infection or severe comorbiditiessuch as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes; 4. Failure to observe test requirements; 5. Pregnancy (verified by serum or urine ß-human chorionic gonadotropin (ß-HCG)) or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial progression-free survival;Intracranial objective response rate;Intracranial duration of Overall Response;Intracranial disease control rate; | — |
Countries
China
Contacts
Public ContactQingsheng Xu
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed