The researchers are doing this study to find out whether SX-682 in combination with proton craniospinal irradiation (pCSI) is a safe treatment approach for people with melanoma or non-small cell lung cancer (NSCLC) with leptomeningeal disease (LMD). The researchers will also look at whether the treatment combination is effective against participants' cancer.
Age ≥ 18
Written informed consent
ECOG 0-2
Positive CSF cytology for malignancy and/or positive CSF circulating tumor cells
Patient who is unable to undergo MRI brain and spine with gadolinium contrast
Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances
Multiple, serious neurologic deficits, including encephalopathy
Single group
SX-682
DrugPatients will receive SX-682 200 mg by mouth twice a day up to cycle 3. Subsequently, all patients will receive systemic therapy of the investigator's choice.
Proton Craniospinal Irradiation (pCSI)
RadiationThe total prescribed dose will be 30Gy (RBE) in 3Gy (RBE) daily fractions.
Incidence, severity, and type of adverse event
will be graded per CTCAE v 6.0
Overall survival (OS)
OS will be defined as the time from initiation of SX-682 to death from any cause. Patients alive at last follow-up will be censored at that date.
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
National Comprehensive Cancer Network
Collaborator
Syntrix Pharmaceuticals
Collaborator
