Utidelone Injection Combined with Bevacizumab Injection for Non-small Cell Lung Cancer Patients with Brain Metastases

Patients with non-small cell lung cancer and brain metastases were enrolled in this study. The first stage consisted of a safety run-in (combination group only) and an expansion. During the safety run-in phase, a 3+3 dose step-down design was used, starting with 30mg/m2/d of Utidelone,D1-D5,Q3W plus Bevacizumab 15mg/kg/Q3w. The dose of Utidelone was reduced by up to one dose (to 25mg per square meter), and the dose of Bevacizumab was unchanged (15mg/kg/Q3w). We planned to enroll 3 to 12 patients in the safety run-in. In the extension, the patients were randomly assigned to the combination group and the monotherapy group (hereinafter referred to as the monotherapy group). 30 patients were planned to be enrolled in the monotherapy group, and 24 or 27 patients were enrolled in the combination group according to the safety run-in. The second stage of dosing was the same as the first stage of expansion in the combination-therapy group, and the results of the first stage determined whether to proceed to the second stage. If second stage was reached, an additional 52 patients would be enrolled.