Sponsor: NRG
Sponsor Study ID: NRG HN010
Study Title: A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado Trastuzumab Emtansine For Recurrent, Metastatic or Treatment Naïve, Unresectable HER-2 Positive Salivary Gland Cancer
CTO #: 103799
NCT Number: NCT05408845
Phase: II
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lip, Oral Cavity and Pharynx
Study Objectives: To determine if trastuzumab emtansine (ado-trastuzumab emtansine [T-DM1]) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment.