A drug called Sac-TMT with brain radiation for lung cancer that spread to the brain
Official title: Sacituzumab Tirumotecan（Sac-TMT） and Brain Radotherapy for EGFR+ NSCLC With Brain Mets
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 asks if a new drug plus brain radiation can slow brain tumors.
Read our full plain-language summary
What the trial team says
his study is a Phase II, multicenter clinical trial evaluating the combination of an antibody-drug conjugate (ADC) called Sacituzumab Tirumotecan (SKB264) and brain radiotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has spread to the brain. All participants have EGFR gene mutations and have experienced disease progression in the brain after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI). The study aims to assess how well this combination therapy controls brain tumor growth and its safety profile. Approximately 53 participants will be enrolled. The treatment involves SKB264 administered intravenously at a dose of 5 mg/kg every two weeks. Participants will receive one to two cycles of SKB264 alone, followed by brain radiotherapy (either stereotactic radiosurgery or whole-brain radiotherapy). SKB264 will be temporarily paused during radiotherapy and resumed afterward. The study is conducted in two phases: a safety run-in phase with 5 participants to evaluate initial safety using a Bayesian monitoring model, followed by an expansion phase with 48 additional participants. The primary endpoint is intracranial progression-free survival (iPFS) as assessed by investigators using RECIST 1.1 criteria. Secondary endpoints include intracranial objective response rate (iORR), overall response rate (ORR), overall survival (OS), progression-free survival (PFS), and safety. Exploratory endpoints include functional MRI assessments of brain function and cognitive changes, quality of life evaluations using the EORTC QLQ-C30 questionnaire, and biomarker analyses. The study is expected to run from March 2026 to March 2028, with each participant followed for approximately 12 months. This research is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Key facts
- Registry number
- NCT07789444
- Stage of testing
- Phase 2
- Conditions studied
- Non-Small Cell Lung Cancer, Brain Metastases From Non-small Cell Lung Cancer (NSCLC), EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
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.