NCT07778940
Thiotepa Administration Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI.
Not Yet Recruiting · Phase 2 · Tianjin Medical University Cancer Institute and Hospital · registry updated 2026-08-21
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The goal of this clinical trial is to learn if the Thiotepa administration via Ommaya Reservoir works to treat non-small cell lung cancer with leptomeningeal metastases resistant to EGFR TKI. The main questions to answer are: Is Thiotepa administration via Ommaya Reservoir safe to inject? How effective is thiotepa via Ommaya Reservoir in intracranial-disease control? Participants will： Stage 1: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, twice every week, for 4 consecutive weeks; Stage 2: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, once every week, for 4 consecutive weeks; Stage 3: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, once a month, for 4 consecutive months; Before each intrathecal administration, a preliminary intrathecal injection of dexamethasone, 2.5 mg/dose, is given.
Inclusion
- Age between 18 and 75 years.
- Male or female of non-childbearing potential, or female of childbearing potential who is not pregnant or lactating.
- ECOG performance status of 0 to 2, with no deterioration within the past 7 days.
- Radiological and/or cerebrospinal fluid (CSF) cytological evidence of leptomeningeal metastases (LM). The diagnosis of non-small cell lung cancer (NSCLC) must be confirmed by histological and/or cytological examination.
- Patients must meet at least one of the following criteria: failure of first- or second-generation TKI therapy with T790M mutation negative; failure of third-generation TKI therapy; or EGFR mutation negative with failure of first-line therapy.
- If concurrent brain parenchymal metastases are present, they must have received appropriate treatment or been evaluated as stable over the past three months. Additionally, extracranial lesions must be evaluated as stable under the current treatment regimen.
Exclusion
- Patients requiring ventriculoperitoneal (VP) shunt placement due to elevated intracranial pressure.
- History of epilepsy unrelated to leptomeningeal metastases.
- Evidence of any neurological functional failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy as shown on imaging, or a Glasgow Coma Scale (GCS) score \< 11.
- Evidence of any extensive and fatal progressive systemic disease with no effective treatment available.
- Prior allogeneic bone marrow transplantation or solid organ transplantation. Uncontrolled hypertension prior to enrollment, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
- Surgical procedures involving vital organs within 3 months prior to enrollment.