Feldkirch

Researchers are evaluating the effectiveness and safety of a combination treatment called triple therapy, which includes bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin. This study focuses on patients with primary hypercholesterolemia or mixed dyslipidemia who are at high or very high cardiovascular risk. The goal is to understand how well this combination lowers LDL cholesterol (LDL-C) in a real-world clinical setting. The study observes patients who have already started triple therapy within the last four weeks. No drugs are administered as part of this study; instead, it monitors the ongoing treatment with bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin. The study measures LDL-C changes from baseline to eight weeks after starting triple therapy and continues follow-up for one year to assess lipid goal achievement, adherence to therapy, treatment changes, laboratory value shifts, and occurrence of cardiovascular events. Participants will have their LDL-C levels and other lab values assessed at baseline, eight weeks, and one year after starting triple therapy. Researchers will collect data on adverse events, adherence to treatment, and cardiovascular outcomes such as heart attack, stroke, death from cardiovascular causes, and coronary procedures during the follow-up year. The study also tracks treatment pathways and changes over this period to better understand real-world use and effectiveness of this triple therapy approach.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) compared to treatment chosen by physicians for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). The study aims to find out if I-DXd can improve the objective response rate, meaning the proportion of patients whose cancer shrinks or disappears, and extend overall survival time compared to other treatments. Secondary goals include assessing safety, patient-reported outcomes, immune response to I-DXd, B7-H3 protein levels, and how the drug is processed in the body. Participants will receive either I-DXd at a dose of 12 mg/kg given intravenously on the first day of each 21-day treatment cycle or one of the physician's choice treatments including Topotecan, Amrubicin, or Lurbinectedin, administered according to local standards of care. The study is randomized and open-label, meaning treatments are assigned by chance and both patients and doctors know which treatment is given. During the study, participants will be closely monitored with tumor assessments to evaluate response and detect disease progression, safety evaluations, and quality of life questionnaires. The main outcomes measured are the objective response rate assessed by a blinded independent review and overall survival time, tracked for up to approximately five years after randomization. Researchers will also monitor for any adverse effects and collect health economics data to understand the broader impact of treatments.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

This research aims to evaluate the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy in adults with previously untreated, unresectable, or metastatic colorectal cancer. The study is a blinded, randomized Phase 2/3 trial targeting participants with histologically confirmed recurrent or metastatic colorectal adenocarcinoma that cannot be cured with surgery. Participants must not have certain genetic markers such as mismatch repair deficiency, microsatellite instability-high status, or BRAF V600E mutation. Participants will receive either pumitamig or bevacizumab along with chemotherapy regimens including FOLFOX, FOLFIRI, or CAPOX at specified doses and schedules. The interventions involve administering these drugs on specified days, though exact dosing details are not provided. The study compares these two treatment combinations to assess their safety and efficacy in this patient population. Throughout the study, participants will be monitored for tumor response using RECIST v1.1 criteria, progression-free survival, and overall survival for up to five years. Researchers will evaluate confirmed complete or partial tumor responses, survival rates, and disease progression. The study includes regular assessments to track treatment effects and safety over a long-term follow-up period, ensuring comprehensive monitoring of participant outcomes.

Researchers are evaluating whether neoadjuvant endocrine therapy is at least as effective as neoadjuvant chemotherapy for treating patients with early and locally advanced estrogen receptor-positive (ER+), HER2-negative breast cancer who show no detectable circulating tumor DNA (ctDNA) in their blood and have a low Ki-67 value after initial therapy. This phase II, prospective, randomized, controlled, open-label study focuses on participants whose tumors respond to endocrine therapy, aiming to compare treatment effectiveness and quality of life outcomes between the two approaches. Participants first undergo a 4-week Run-in phase taking aromatase inhibitors (or tamoxifen if aromatase inhibitors are not tolerated) while providing blood and tumor samples for ctDNA assessment and Ki-67 analysis. Based on these results, they are assigned to one of three treatment arms: neoadjuvant endocrine therapy (aromatase inhibitors or tamoxifen), neoadjuvant chemotherapy, or chemotherapy if ctDNA is detected or Ki-67 is high. The main treatment phase lasts 6 to 8 months, followed by surgery. Throughout the study, participants attend clinic visits before treatment, during the Run-in phase, before the main treatment, mid-treatment, after completing therapy, at surgery and post-surgery, and annually for five years. They provide blood samples for ctDNA analysis, undergo biopsies, and complete questionnaires about quality of life, symptoms, and sexual health. The primary outcome measured is the modified Preoperative Endocrine Prognostic Index (PEPI) score from randomization to surgery.

Chronic lymphocytic leukemia (CLL) has long been considered incurable, except in some patients who can undergo stem cell transplants. Advances such as chemoimmunotherapy with FCR (fludarabine, cyclophosphamide, rituximab) have helped some patients remain relapse-free for up to 10 years. Newer treatments like BTK and Bcl2 inhibitors, along with improved understanding of disease factors, show promise but their long-term effects on progression-free survival, cure rates, and safety are not fully known. This trial is the first nationwide registry in Austria to systematically document CLL patients' medical and treatment data. This registry follows multiple centers in Austria, collecting patient information from medical charts without requiring extra diagnostic or treatment procedures. Data includes patient characteristics, genetics, disease progression, treatments, outcomes, and side effects over time. Participation does not interfere with usual care, and confidentiality is ensured by assigning unique patient numbers. Patients aged 18 and older with CLL will have their routine medical data tracked longitudinally until death or loss to follow-up. Researchers will evaluate general patient traits, genetic profiles, treatment needs, concomitant illnesses, types of therapies, patient outcomes, and toxicities over a 7-year period. No additional visits or procedures are required beyond regular clinical care and chart reviews.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.