WHO ICTRP trial

A PHASE 2, MULTICENTER, OPEN-LABEL, 2-COHORT STUDY OF TRASTUZUMAB DERUXTECAN…

NL-OMON54783 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting

Key facts

Trial ID NL-OMON54783
Public title A PHASE 2, MULTICENTER, OPEN-LABEL, 2-COHORT STUDY OF TRASTUZUMAB DERUXTECAN (DS-8201a), AN ANTI-HER2 ANTIBODY DRUG CONJUGATE (ADC), FOR HER2-OVER-EXPRESSING OR -MUTATED, UNRESECTABLE AND/OR METASTATIC NONSMALL CELL LUNG CANCER (NSCLC)
Scientific title A PHASE 2, MULTICENTER, OPEN-LABEL, 2-COHORT STUDY OF TRASTUZUMAB DERUXTECAN (DS-8201a), AN ANTI-HER2 ANTIBODY DRUG CONJUGATE (ADC), FOR HER2-OVER-EXPRESSING OR -MUTATED, UNRESECTABLE AND/OR METASTATIC NONSMALL CELL LUNG CANCER (NSCLC) - DS8201-A-U204
Primary sponsor DAIICHI SANKYO, INC.
Registry Overview of Medical Research in the Netherlands (NL-OMON)
Recruitment status Recruiting
Study type Interventional
Phase 2
Countries Japan;Netherlands;United States of America
Conditions Lung Caner Metastatic Non-Small Cell Lung Cancer;10038666;Lung Caner;Metastatic Non-Small Cell Lung Cancer
Interventions There will be subjects allocated to two different cohorts according to the centrally confirmed HER2 IHC status and documented HER2 mutation status. All subjects will receive trastuzumab deruxtecan treatment of the 6.4 mg/kg Q3W. ;Metastatic…
Registration date Jul 18, 2023
Target size 31
Secondary IDs 2017-004781-94;NL65483.031.18
Registry page onderzoekmetmensen.nl

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