TUXEDO-5
MULTICENTER, OPEN-LABEL, NON-COMPARATIVE, SINGLE-ARM, PHASE II TRIAL OF DATOPOTAMAB DERUXTECAN FOR NON-SQUAMOUS NON-SMALL CELL LUNG CANCER PATIENTS WITH ACTIVE BRAIN METASTASES 
Non-squamous non-small cell lung cancer patients with active brain metastases
II
20
10
Spain & Austria
Set-up
CLINICAL TRIAL DETAILS
THE PRIMARY OBJECTIVE IS TO ASSESS THE INTRACRANIAL RESPONSE RATE OF DATOPOTAMAB DERUXTECAN AT ANY TIMEPOINT PER LOCAL INVESTIGATOR AS JUDGED BY BEST CENTRAL NERVOUS SYSTEM RESPONSE ACCORDING TO RESPONSE ASSESSMENT IN NEURO-ONCOLOGY BRAIN METASTASES (RANO-BM) CRITERIA.
THE STUDY WILL ALSO ASSESS ORR IN EXTRACRANIAL AND OVERALL LESIONS AS PER RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) V.1.1, PFS, CBR, DCR, TTR, AND DoR FOR INTRACRANIAL LESIONS AS PER RANO-BM CRITERIA AND FOR EXTRACRANIAL LESIONS AS PER RECIST V.1.1, OVERALL SURVIVAL, BEST PERCENTAGE OF CHANGE IN TUMOR BURDEN AS PER EUROPEAN ASSOCIATION OF NEURO-ONCOLOGY GUIDELINES, SAFETY, QUALITY OF LIFE AND NEUROLOGIC FUNCTION THROUGH NANO SCALE.
TUXEDO-5 AT CLINICALTRIALS.GOV
TUMOR TYPE
PHASE
N
SITES
COUNTRY
STATUS
TRIAL RESUME
