Feldkirch

Researchers are studying the use of bempedoic acid combined with ezetimibe and either rosuvastatin or atorvastatin, known as triple therapy, in adults with primary hypercholesterolemia or mixed dyslipidemia. The study aims to evaluate the effectiveness and safety of this combination in real-world clinical practice, focusing on lowering LDL cholesterol LDL-C levels. This is an observational study, meaning no drugs are administered by the study team instead, existing treatments are monitored. Participants are adults who have started triple therapy within the past four weeks and are followed for up to one year. The study looks at LDL-C changes after 8 weeks and 1 year of treatment, adherence to the therapy, side effects, and cardiovascular events such as heart attacks and strokes. No new treatments are given instead, researchers collect information on the participants ongoing treatments involving bempedoic acid, ezetimibe, and either rosuvastatin or atorvastatin. During the study, participants LDL-C levels, laboratory values, and treatment adherence are regularly reviewed. Researchers will also record any adverse events and track major cardiovascular events over the year. The primary measurement is the change in LDL-C from before treatment to 8 weeks after starting triple therapy. Participants health is followed through routine clinical assessments, and the study lasts for up to one year after beginning triple therapy.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating the effectiveness and safety of Ifinatamab Deruxtecan I-DXd compared to the treatment chosen by a physician for people with relapsed small cell lung cancer SCLC. This Phase 3 study aims to see if I-DXd can help participants live longer than current treatments, while also examining other effects such as patient-reported outcomes, immune response, and the drugs behavior in the body. Participants will be randomly assigned to one of two groups. One group will receive I-DXd as an intravenous infusion at a dose of 12 mgkg every 21 days until the disease worsens, unacceptable side effects occur, or other stopping reasons arise. The other group will receive one of the standard treatments chosen by their doctortopotecan, lurbinectedin, or amrubicinaccording to local approved dosing guidelines and until treatment discontinuation criteria are met. During the study, participants will be closely monitored with regular imaging and assessments to track tumor response, disease progression, and quality of life using questionnaires. Safety events and immune responses will also be recorded. Pharmacokinetic samples will be collected at specified times to understand how I-DXd behaves in the body. Participants may remain in the study for up to approximately 3.7 years, allowing for long-term evaluation of outcomes and safety.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

Researchers are evaluating the effectiveness of Pumitamig compared to Pembrolizumab in adults with previously untreated advanced Non-Small Cell Lung Cancer NSCLC who have a PD-L1 expression level of 50% or higher. This Phase 3 randomized, double-blind study focuses on patients with locally advanced or metastatic NSCLC to better understand first-line treatment options. Participants receive either Pumitamig or Pembrolizumab as the study drug, given at specified doses on certain days. The study uses a parallel design with two treatment groups to compare these therapies as first-line options. The study is planned to continue until October 2031, with treatment and follow-up periods extending up to approximately 5 years for overall survival assessments. During the study, participants will have regular assessments to monitor disease progression and response to treatment using criteria like RECIST v1.1. Researchers will evaluate progression-free survival, overall survival, objective response rates, duration of response, disease control rate, and symptom changes related to lung cancer over time. Safety and treatment effects will be closely monitored throughout the study duration.

This trial studies participants with previously untreated, unresectable, or metastatic colorectal cancer. It evaluates the safety and effectiveness of pumitamig combined with chemotherapy compared to bevacizumab combined with chemotherapy. The study includes participants who do not have specific genetic markers like dMMR, MSI-H, or BRAF V600E mutations, which may affect treatment response. Participants receive treatment with study drugs such as pumitamig, bevacizumab, and chemotherapy regimens including FOLFOX, FOLFIRI, and CAPOX. The treatments are given at specified doses on specific days. The study uses a randomized, double-blind design with multiple experimental and comparator arms to assess these combinations. Throughout the study, participants undergo regular assessments to measure tumor response and survival outcomes. Key evaluations include imaging tests using RECIST v1.1 criteria, monitored by both investigators and independent reviewers, over a period of up to 5 years. Researchers track objective response, progression-free survival, and overall survival to determine treatment outcomes and safety.

Transthyretin amyloid cardiomyopathy ATTR-CM is a condition where a protein called transthyretin TTR breaks down and forms harmful clumps called amyloid, which deposit in the heart wall and impair its ability to pump blood properly. This can lead to heart failure and may be caused by age-related changes or genetic factors. Researchers are studying acoramidis, a drug that attaches to TTR to stabilize it and reduce amyloid formation, in participants who were previously treated with tafamidis, another TTR stabilizer. The goal is to see if switching to acoramidis increases blood TTR levels beyond those achieved with tafamidis. Participants will take acoramidis as two 356 mg tablets twice daily by mouth for up to 6 months. Before starting, all participants will continue their tafamidis treatment during a screening period. The study involves a single treatment group receiving acoramidis, and the main measurement is the change in serum TTR levels from baseline to 6 months or earlier if treatment stops. Secondary measures include heart function markers, kidney and thyroid assessments, and quality of life scores. Participants will be involved in nine check-ins, including two visits at the study site at screening and the end of treatment, six home visits by a study nurse during the first month and at 3 months, and a final phone check-in. Assessments include electrocardiograms, blood pressure, heart rate, and collection of blood and urine samples to monitor various health markers. The total participation time is about 8 months, during which researchers will monitor safety and treatment effects closely.

Researchers are investigating whether neoadjuvant endocrine therapy is at least as effective as neoadjuvant chemotherapy for treating patients with early or locally advanced estrogen receptor-positive and HER2-negative breast cancer who have no detectable circulating tumor DNA ctDNA before treatment and show endocrine responsiveness. This phase II performance study focuses on comparing these treatments effectiveness, measured by the modified preoperative endocrine prognostic index PEPI score at surgery, while also considering quality of life outcomes. Participants first provide blood and tumor samples for ctDNA assessment using the SignateraTM test. They then receive aromatase inhibitor AI therapy for 4 weeks during a Run-in phase, with a tumor biopsy after 3 weeks to evaluate Ki-67 levels. Based on ctDNA results and Ki-67 values, participants are assigned to one of three groups neoadjuvant AI or tamoxifen if AI is not tolerated for responders, or chemotherapy for non-responders. The Main Treatment Phase lasts 6 to 8 months, followed by surgery and a 5-year follow-up period. Throughout the study, participants attend multiple clinic visits for checkups, blood draws for ctDNA monitoring, and questionnaires about quality of life, symptoms, and sexual health. Key assessment points include before treatment start, after 3 weeks of AI therapy, prior to the Main Treatment Phase, mid-therapy, post-treatment, surgery, and annual follow-ups. Some participants receiving adjuvant chemotherapy have an additional visit after completing chemotherapy. The study evaluates several outcomes including PEPI score, residual cancer burden, survival measures, and breast conservation rates.

Researchers are observing patients with Chronic Lymphocytic Leukemia CLL to better understand this disease which has long been considered incurable except in rare cases involving stem cell transplants. Recent advances like chemoimmunotherapy and new drugs targeting specific disease mechanisms have improved outcomes for some patients, but long-term effects and safety of new treatments remain uncertain. This Austrian registry study aims to systematically collect data on CLL patients across the country to fill this knowledge gap. This study collects information by reviewing existing medical records from multiple centers without altering any treatment plans. It gathers data on patient characteristics, genetic profiles, treatments received, side effects, and disease progression over time. The registry relies solely on routine clinical data already recorded in patient charts, ensuring no extra tests or procedures are required for participation. Participants will be followed longitudinally through their medical records until death or loss to follow-up. Data such as survival, tumor progression, treatment patterns, coexisting conditions, and toxicities are monitored for up to seven years. Personal identifiers are replaced with unique codes to protect confidentiality. The study does not interfere with standard care and requires written consent before data entry from living patients only, with no consent needed for deceased individuals.