Sponsor: Adlai Nortye Biopharma Co., Ltd.
Sponsor Study ID: AN2025H0301
Study Title: The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
CTO #: 103435
NCT Number: NCT04338399
Phase: III
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Larynx; Lip, Oral Cavity and Pharynx
Study Objectives: The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior platinum-based therapy with or without prior anti PD 1/anti PD L1 therapy.