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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Age: 18Years +All GendersPhase 3
1365 locations
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Actively Recruiting

Researchers are comparing the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone for people with metastatic non-small cell lung cancer NSCLC who have high PD-L1 expression 50% or more. The study aims to see if the combination improves overall survival compared to pembrolizumab by itself. This is a Phase 3 clinical trial focusing on first-line treatment in this patient group. Participants receive either sacituzumab tirumotecan plus pembrolizumab or pembrolizumab alone. Sacituzumab tirumotecan is given by intravenous infusion on Days 1, 15, and 29 of each 6-week cycle, while pembrolizumab is given by intravenous infusion every 6 weeks for up to 18 cycles. Supportive medications such as diphenhydramine, acetaminophen, dexamethasone, and H2 antagonists are used before some infusions to manage side effects. Participants who complete the first pembrolizumab course and show disease progression may be eligible for additional pembrolizumab cycles. Throughout the trial, participants will have regular assessments including scans and evaluations to measure overall survival and other outcomes such as progression-free survival, tumor response, and quality of life. Researchers will also monitor symptoms like cough, chest pain, and breathing difficulties. Safety is closely followed over up to approximately 77 months, with detailed data collected on adverse events and treatment discontinuation. The total participation duration can last several years depending on individual progress and treatment response.

Age: 18Years +All GendersPhase 3
220 locations