Launceston

Researchers are evaluating LTI-03, an experimental inhaled medication, for treating Idiopathic Pulmonary Fibrosis (IPF), a progressive lung disease causing scarring and breathing difficulties. This Phase 2, randomized, double-blind, placebo-controlled study aims to assess LTI-03's safety, side effects, impact on lung scarring, and symptom improvement in patients diagnosed with IPF within the past 5 years. Participants may be on stable doses of approved IPF treatments such as nintedanib, pirfenidone, or nerandomilast. Participants will be randomly assigned to receive either LTI-03 or placebo capsules, both inhaled using a dry powder inhaler device. The study includes a 28-day screening period, a 24-week treatment period, and a 4-week follow-up. About 120 participants will self-administer the study drug via inhaler throughout the treatment phase, with placebo capsules identical in appearance but without active medication. During up to nine clinic visits, participants will undergo lung function tests including spirometry at every visit and a diffusion capacity test (DLCO) at screening. Other evaluations include vital signs, ECGs, blood tests for safety labs and disease biomarkers, questionnaires assessing symptoms, and specialized lung scans at baseline and end of treatment to measure fibrosis changes. Researchers will monitor safety by tracking treatment-emergent adverse events from day 1 through week 24.

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are evaluating an experimental drug called linvoseltamab (REGN5458) for adults with relapsed or refractory multiple myeloma who have had one to four previous treatments and have standard treatment options available. This phase 3 study compares linvoseltamab to a combination of three cancer drugs: elotuzumab, pomalidomide, and dexamethasone (EPd). The study aims to assess the safety and effectiveness of linvoseltamab compared to EPd, including how long participants benefit, tumor response, side effects, survival, and pain improvement. Linvoseltamab is given by intravenous infusion, while the comparison group receives elotuzumab by infusion and pomalidomide capsules and dexamethasone tablets or capsules by mouth or IV. Participants are randomly assigned to receive either linvoseltamab or the EPd combination. The study includes participants who have previously received lenalidomide, a proteasome inhibitor, and in some cases, a CD38 antibody. Treatment continues as per protocol with ongoing monitoring. Participants will undergo regular assessments to evaluate their disease response and side effects. Researchers will monitor progression-free survival for up to approximately five years. Assessments include measuring tumor response, survival, pain levels, and safety. Participants must have measurable disease and adequate organ function, and they will be followed closely to assess how well the treatments work and their safety over time.

Researchers are evaluating a new medicine called Sofetabart Mipitecan (LY4170156) in adults with certain types of ovarian, peritoneal, and fallopian tube cancers. This phase 3 study has two parts: Part A focuses on participants whose cancer no longer responds to platinum-based chemotherapy, while Part B includes those whose cancer still responds to platinum-based treatments. The study aims to compare Sofetabart Mipitecan against current standard treatments and to better understand its safety. Participants receive treatments administered through intravenous (IV) infusions. In Part A, Sofetabart Mipitecan is compared with various chemotherapy drugs or mirvetuximab soravtansine. In Part B, Sofetabart Mipitecan combined with bevacizumab is compared with platinum-based chemotherapy plus bevacizumab. Each participant's time in the study depends on how they respond to the treatment. During the study, researchers monitor participants for progression-free survival, measuring the time from randomization until cancer progression or death, for up to 70 months. Participants undergo assessments including scans to track tumor changes and evaluations of safety and side effects. The study collects tumor tissue samples and monitors participants' health status regularly to understand treatment effects and safety over time.

The trial focuses on adults preparing for lung cancer or major abdominal cancer surgery, either open or video-assisted. It evaluates the impact of an education program delivered through telehealth compared to usual care on the development of respiratory complications after surgery. The study also explores effects on hospital stay length, surgical recovery, physical function and activity, self-confidence, behavior changes, symptoms, quality of life, days alive and out of hospital, health service use, and survival. A sub-study involves a smaller group receiving a personalized inspiratory muscle training and walking program via telehealth before lung cancer surgery. Participants are assigned to receive either the tele-prehabilitation education sessions called Surgery School, which include videos and live facilitation by a clinician, or usual care. The sub-study participants additionally receive individualized inspiratory muscle training and walking exercises delivered and monitored by a physiotherapist via telehealth. Usual care is reviewed regularly throughout the trial to monitor any changes in hospital or medical care practices. During the study, researchers monitor participants daily for up to seven days after surgery or until hospital discharge to assess post-operative lung complications. Other assessments include surgical recovery, physical activity, symptoms, and quality of life. The study collects data on hospital length of stay, health service use, and survival. Participants provide consent and must meet criteria to join, with ongoing monitoring throughout their surgical and recovery process.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are investigating treatments for bloodstream infections caused by the bacterium Staphylococcus aureus, which can be deadly within three months of infection. This international, multi-center Phase 4 adaptive platform trial evaluates multiple treatment options simultaneously to identify those that reduce death rates within 90 days of infection. The trial adapts over time by assigning more patients to better-performing treatments, removing less effective ones, and adding new options, aiming to find the best combination of therapies for patients with this serious infection. Participants receive various antibiotic treatments such as Cefazolin, Penicillin, Clindamycin, Vancomycin or Daptomycin, as well as strategies like early switching to oral antibiotics. The trial also includes whole body FDG PET/CT imaging using standardized protocols to support diagnosis and treatment decisions. Patients are randomly assigned to different concurrent treatment options currently used in routine care, with ongoing adjustments based on accumulating results. During the study, participants undergo regular evaluations including blood culture monitoring to confirm infection clearance, clinical assessments, and imaging when applicable. Researchers track all-cause mortality up to 90 days after enrollment as the primary outcome. The trial infrastructure supports additional sub-studies, with patient safety and treatment effectiveness closely monitored throughout the trial period.

Researchers are establishing a detailed, prospective registry called EXCEL to study patients in Australia and New Zealand who require extracorporeal membrane oxygenation (ECMO) due to acute cardiac or respiratory failure or cardiac arrest. ECMO is a complex treatment used for the sickest patients in intensive care units when their heart or lungs are not functioning properly. The study aims to monitor long-term outcomes, understand patient selection, complications, costs, and patient-reported results while identifying best practices and improving care through a coordinated network. The registry collects comprehensive data from ECMO centers across the two countries to track treatment practices and patient outcomes. The EXCEL project uses a closed-loop feedback system and the Theoretical Domains Framework to identify gaps between evidence and practice and to explore factors that help or hinder optimal care. This approach supports embedding clinical trials and translating findings into measurable improvements in ECMO services. Participants are patients admitted to adult hospitals in Australia and New Zealand who receive ECMO treatment. The study looks at disability-free survival at 6 months, defined as being alive without significant disability based on a standardized assessment tool. The registry provides ongoing data collection on patient experiences, complications, and outcomes to enhance understanding and improve the quality and safety of ECMO care over time.