Eastbourne

Researchers are evaluating the drug brenipatide compared to a placebo in adults with Alcohol Use Disorder AUD and hazardous alcohol use. The study aims to assess the drugs effect on drinking patterns and its safety. This phase 3, randomized, double-blind trial is sponsored by Eli Lilly and Company and will last about 56 weeks. Participants receive escalating doses of brenipatide or placebo, administered as subcutaneous injections. The study includes a multi-period design with two experimental periods for brenipatide dosing and a placebo group. Participants or trained support persons will perform self-injections, and the study medication is blinded to ensure unbiased results. Throughout the trial, participants will attend regular visits for assessments including drinking behavior using the Timeline Followback Method, alcohol craving scales, health questionnaires, and body weight measurements. Blood samples will be taken to analyze drug levels and immune response. Participants will keep diaries and complete questionnaires to monitor adherence and effects. Safety and tolerability will be closely monitored during the 56-week participation period.

Researchers are evaluating brenipatide, compared to a placebo, in adults with moderate-to-severe Alcohol Use Disorder AUD. This study aims to assess how brenipatide affects drinking patterns and its safety over a period of approximately 56 weeks. The trial is a phase 3, multicenter, randomized, double-blind study sponsored by Eli Lilly and Company. Participants will receive escalating doses of brenipatide or placebo, administered by subcutaneous injection. The study includes multiple experimental periods where participants receive the study drug or placebo under controlled conditions. The dosing is carefully monitored to assess the drugs effects compared to placebo. During the study, participants will undergo regular assessments including drinking behavior tracked by the Timeline Followback Method, craving levels measured by the Penn Alcohol Craving Scale, and health outcomes collected through questionnaires. Safety will be monitored by evaluating laboratory tests and adverse events. The total participation lasts up to 56 weeks with ongoing monitoring throughout this period.

Researchers are studying the outcomes of treatments containing amivantamab for people with advanced non-small cell lung cancer NSCLC that have specific mutations in the epidermal growth factor receptor EGFR gene. This research focuses on patients with common EGFR mutations, including exon 19 deletions or exon 21 L858R substitutions, to understand how these regimens perform in real-world medical practice. The study aims to capture clinical and health-related results for this serious lung cancer type, particularly when it has spread to other parts of the body. The study observes two groups of participants receiving amivantamab-based treatments as part of their standard care. One group includes patients treated with amivantamab combined with carboplatin and pemetrexed after previous therapy has failed. The other group involves participants receiving amivantamab with lazertinib as their first-line therapy. No study drugs are provided instead, researchers collect data from routine clinical visits, tracking how patients are treated according to usual medical practice. Participants are monitored for up to about 60 months to gather information on how long they continue treatment, progression-free survival, overall survival, and time to next treatment. Researchers also record adverse events, dose changes, use of other medications, and quality of life using specific questionnaires. This long-term observation helps to understand treatment impact and safety in everyday clinical settings without additional interventions or procedures beyond standard care.

Researchers are studying preventive treatments to reduce the occurrence, severity, and duration of taste changes dysgeusia caused by talquetamab and ramantamig in patients with relapsed or refractory multiple myeloma RRMM who have been previously treated with certain therapies. The study aims to better understand the signs and symptoms of taste changes related to these treatments. This is a Phase 2, open-label, randomized clinical trial focused on GPRC5D-related oral events. Participants with RRMM who have been exposed to at least one proteasome inhibitor, one immunomodulatory drug, and an anti-CD38 monoclonal antibody will receive talquetamab or ramantamig. Talquetamab is given subcutaneously, and ramantamig is given as a single step-up subcutaneous dose followed by treatment doses. Participants are divided into cohorts receiving talquetamab alone or talquetamab combined with one of four prophylaxis treatments oral or topical, starting before talquetamab treatment. Prophylaxis treatments continue for up to 12 months, with possible extension based on benefit and physician decision. During the study, participants will be closely monitored with taste tests, assessments of oral symptoms, quality of life questionnaires, and tracking of side effects. Researchers will measure the frequency and severity of taste changes, time to onset and resolution, and other oral toxicities over up to 36 months. Safety, response to treatment, and changes in physical health measures such as body weight and BMI will also be evaluated. The study continues until disease progression, unacceptable toxicity, withdrawal, or study end, with ongoing assessments throughout.

Researchers are conducting a randomized phase III clinical trial to evaluate treatments for patients with unilateral malignant pleural mesothelioma MPM. The study aims to compare progression-free survival and overall survival between two groups. It also assesses safety, tolerability, quality of life, and local disease control. Patients are grouped based on tumor histology, treatment center, tumor location, and time since diagnosis. Participants are randomly assigned to one of two groups. The experimental group receives proton beam therapy PBT to the hemithorax 50 Gy in 25 daily fractions over five weeks, with a boost to 60 Gy for visible tumors. The control group follows standard care with active surveillance and no immediate treatment. Both groups are monitored for two years after randomization, with clinic visits every three months in the first year and every four months in the second year. If disease progresses in the control group, patients may receive immunotherapy or chemotherapy based on doctor recommendation. During the study, patients undergo evaluations including scans, pulmonary function tests, and quality of life questionnaires. Researchers track adverse events related to proton therapy and collect data on healthcare resource use and informal care. Follow-up occurs at local centers for two years after treatment start. The main outcomes measured are time to disease progression and overall survival, assessing the potential benefits and risks of proton beam therapy for MPM.

Researchers are evaluating the study medicine called elranatamab in people with multiple myeloma MM that has returned or not responded to previous treatments, including prior anti-CD38 antibody and lenalidomide therapies. This Phase 3 trial aims to compare elranatamab with other commonly used combination therapies to understand its safety and how well it works for people with relapsed or refractory MM. Participants will be randomly assigned to receive either elranatamab alone or an investigators choice of combination therapies. Elranatamab is given as a weekly shot under the skin at the study clinic, which may become less frequent later. The combination therapies include various medicines taken by mouth and given as shots or intravenous infusions at the clinic. Treatment continues until the MM no longer responds. During the study, participants will visit the clinic regularly for monitoring and assessments, including evaluations of disease progression and response to treatment. Follow-up contacts by telephone or visits will continue after treatment ends. The main measure is progression-free survival, and other outcomes include overall survival, response rates, quality of life, and safety. The study may last up to about five years for some measures.

Researchers are studying patients with chronic lymphocytic leukaemia CLL who have been treated with acalabrutinib in the United Kingdom. This observational study aims to describe the characteristics and real-world clinical outcomes of these patients, especially those who started acalabrutinib treatment as part of the UK Early Access Programme. The study seeks to provide UK-specific data on how patients respond to and tolerate acalabrutinib in typical clinical settings. The study involves reviewing clinical records of treatment-naefve CLL patients who began acalabrutinib between April 1, 2020, and April 1, 2021. The focus is on patients treated in the first-line setting with acalabrutinib under the Early Access Programme. This non-interventional study does not involve new treatments but collects and analyzes existing data to estimate progression-free survival, overall survival, response rates, treatment patterns, and healthcare resource use. Participants medical information will be gathered from their clinical records following local laws. Researchers will track outcomes such as progression-free survival at various time points up to 60 months, overall survival, response rates, and treatment interruptions. The study design allows for long-term observation of how patients fare with acalabrutinib, providing valuable real-world evidence. The study is expected to continue through April 2027.