October 12 2022
NRG-HN010: A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naïve, Unresectable HER2-positive Salivary Gland Cancer
The World Health Organization (WHO) has identified more than 20 salivary gland cancer (SGC) histologic subtypes, and at this time there is no US Food and Drug Administration (FDA)-approved therapies for this rare, heterogeneous disease. Specifically, salivary duct carcinomas (SDCs), a subtype of SGC as defined by WHO, includes patients that exhibit overexpressed HER2 and is incredibly aggressive. Despite surgery or adjuvant therapy, approximately 44-62% of patients will develop distant metastases and the 5-year overall survival for this population is only about 20-30%.
“NRG-HN010 was designed to test the antibody-drug conjugate ado-trastuzumab emtansine in patients with unresectable, recurrent, or metastatic HER2-positive salivary gland cancer and compare it to treatment with docetaxel and trastuzumab,” stated Alan L. Ho, MD, PhD, of the Memorial Sloan Kettering Cancer Center and the Principal Investigator of the NRG-HN010 trial. “Ado-trastuzumab emtansine is known to inhibit HER2 signaling and produce HER2-directed tumor cell cytotoxicity, and previous clinical data suggest it could be an effective first-line treatment option for these patients.”
Patients who are eligible for NRG-HN010 will be stratified by any prior HER2-targeted therapies received in the adjuvant or neoadjuvant setting at the time of their initial primary diagnosis. Following stratification, patients will be randomly assigned to receive either docetaxel with trastuzumab (TH) or ado-trastuzumab emtansine (T-DM1). The primary objective of this trial is to compare progression-free survival between treatment arms. Additionally, the trial will compare overall survival, overall response rate (ORR), toxicity, patient-reported toxicity, and patient-reported symptomatic adverse events between treatment arms.
Patients who experience disease progression while on the TH treatment arm are able to crossover to the T-DM1 treatment arm within 30 days of their progression.
Additionally, NRG-HN010 will collect blood and tissue samples to assess ORR in patients who receive the crossover treatment following progression of their disease and for future translational science studies examining HER2 status and the impact of TH and T-DM1 treatments.
Learn more about this trial at ClinicalTrials.gov
Protocol documents and materials are located on the CTSU website