Tai An Shi

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are evaluating the efficacy and safety of a combination budesonide and albuterol metered dose inhaler (MDI) compared with an albuterol sulfate MDI in symptomatic Chinese adults with asthma. This Phase III, randomized, double-blind, multicenter, event-driven study aims to reduce the risk of severe asthma exacerbations in this population. The study will enroll approximately 790 participants who meet specific asthma-related eligibility criteria. The study includes three periods: a screening period of 14 to 28 days, a treatment period lasting at least 24 weeks and up to 52 weeks, and a safety follow-up period occurring about two weeks after the final visit. Participants will be randomly assigned to one of two treatment groups, receiving either the budesonide/albuterol MDI or the albuterol sulfate MDI as needed for asthma symptoms or before exercise, alongside their usual maintenance therapy. Participants will undergo assessments including lung function tests, asthma control questionnaires, and monitoring of severe asthma exacerbations throughout the treatment period. Researchers will track the time to the first severe asthma exacerbation as the primary outcome. Safety will be monitored during the follow-up period, and participants must demonstrate the ability to use the inhaler correctly and comply with study procedures throughout the trial.