A drug given into the spinal fluid for lung cancer that has spread to the lining of the brain
Official title: Safety and Efficacy of Intrathecal Sacituzumab Tirumotecan for Leptomeningeal Metastasis in EGFR-TKI-Resistant Non-Small Cell Lung Cancer
Status: Not yet recruiting. It has not opened yet. Ask your care team to watch for it if it looks like a fit.
The trial team last updated this record on .
The short version
This trial is testing whether a drug called sacituzumab tirumotecan can be given safely into the spinal fluid when lung cancer has spread to the lining of the brain and spinal cord.
Read our full plain-language summary
What the trial team says
This study is a Phase I, single-arm, single-center, dose-escalation clinical trial designed to investigate the safety and efficacy of intrathecal injection of sacituzumab tirumotecan (sac-TMT) in patients with EGFR mutation-positive non-small cell lung cancer and leptomeningeal metastasis who have progressed after prior EGFR-TKI therapy, and to determine the optimal dose (RP2D). The study employs an "accelerated titration" combined with a "3+3" dose-escalation design, with a starting dose of 0.05 mg/kg, sequentially escalating to 0.5 mg/kg. The drug is administered via intrathecal injection through an Ommaya reservoir once every 14 days, along with concomitant intrathecal injection of dexamethasone 5 mg to prevent chemical meningitis. The primary endpoints are safety (incidence, severity, and grading of adverse events and serious adverse events) and the recommended dose (RP2D). Secondary endpoints include intracranial objective response rate, time to treatment failure, progression-free survival, and overall survival. The study plans to enroll 8-15 subjects. Efficacy assessment is based on evaluation of neurological symptoms, cerebrospinal fluid cytology, and neuroimaging changes. Special attention is given to adverse events of special interest, including neurotoxicity and bone marrow suppression. This study aims to provide a new treatment strategy for patients with leptomeningeal metastasis after EGFR-TKI resistance and to generate pioneering data for the intrathecal administration of ADC drugs.
Key facts
- Registry number
- NCT07702305
- Stage of testing
- Phase 1
- Conditions studied
- EGFR-TKI-resistant Non-small Cell Lung Cancer With Leptomeningeal Metastasis
Where it is running
No locations are listed for this trial. The trial's own page may have more.
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.