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Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are types of blood cancers that can cause symptoms like enlarged lymph nodes, spleen, or liver, night sweats, weight loss, and fever. People with these conditions have shorter life expectancy, creating an urgent need for new treatments to extend life and control symptoms. This research evaluates the safety and effectiveness of a drug called BGB-16673 compared to other treatments chosen by doctors in participants previously treated with both Bruton tyrosine kinase inhibitors (BTKi) and B-cell leukemia/lymphoma 2 protein inhibitors (BCL2i). Participants with relapsed or refractory CLL or SLL will be randomly assigned to receive either BGB-16673 taken orally or one of the investigator's chosen treatments, which include idelalisib plus rituximab (for CLL only), bendamustine plus rituximab, or venetoclax plus rituximab retreatment. The study plans to include approximately 250 participants worldwide. Treatments are given according to the assigned group to compare how well each controls disease progression. During the study, researchers will monitor participants for about 36 months to measure progression-free survival, which is the length of time patients live without their disease worsening. Participants will undergo assessments including imaging and laboratory tests to evaluate their health and treatment response. Safety and effectiveness will be closely followed throughout the study period to better understand the potential benefits and risks of BGB-16673 compared to other treatment options.

Researchers are studying the safety and effectiveness of brenipatide, given alongside standard treatment, compared to a placebo with standard treatment, to see if it can delay the return of symptoms in adults with major depressive disorder. This is a Phase 3, randomized, double-blind study involving adult participants aged 18 to 75 years. The trial is designed to assess how long it takes for depression symptoms to relapse after starting the adjunctive treatment. Participants will receive either brenipatide or placebo, both administered by subcutaneous injection, in addition to their stable standard of care medication. The study has three main periods: a screening period lasting about one month, followed by a treatment phase of at least 12 months where participants receive the assigned injections, and finally a follow-up period of roughly two months. The total time in the study can be shorter if symptoms worsen or if a participant withdraws. During the trial, participants will need to attend scheduled visits, self-inject the study drug, maintain study diaries, and complete questionnaires. Researchers will monitor participants closely to determine the time until relapse of major depressive disorder symptoms occurs. Safety and adherence to study procedures will be tracked throughout the trial, with the primary outcome measuring the number of days from randomization until relapse.

Researchers are investigating better treatments for people with advanced non-small cell lung cancer (NSCLC) that has specific genetic changes called HER2 mutations. Advanced NSCLC refers to lung cancers that have spread or are unlikely to be controlled with current treatments. HER2 is a protein that helps cells grow, and mutations cause abnormal HER2 leading to cancer growth. This Phase 3 study aims to compare the safety and effectiveness of a new drug, sevabertinib, against standard treatment in patients with this type of lung cancer. Participants will be randomly assigned to receive either sevabertinib tablets twice daily by mouth or standard treatment consisting of cycles of intravenous infusions including drugs like pembrolizumab, cisplatin, carboplatin, and pemetrexed every 21 days. Treatments continue as long as participants benefit without severe side effects or until they or their doctors decide to stop. Participants on standard treatment whose disease worsens may switch to sevabertinib and continue until progression, intolerable side effects, or decision to stop. During the study, participants will undergo imaging scans such as CT, PET, MRI, and X-rays to monitor cancer spread. Health checks include blood and urine tests, heart monitoring with ECG, and pregnancy tests for women. Researchers will ask about participants’ well-being and record any medical problems or side effects experienced. The main outcome measured is progression-free survival over up to about two years.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

Kidney failure is a serious and growing health problem that requires treatment with dialysis or transplantation to prevent fatal outcomes. Haemodialysis, the most common treatment in Australia and worldwide, often causes significant burdens such as fatigue, pain, cramps, and a reduced quality of life. The early months of starting haemodialysis are particularly risky, with high mortality rates possibly linked to the sudden loss of remaining kidney function when patients begin the typical three sessions per week treatment. This trial aims to evaluate whether starting haemodialysis incrementally at two sessions per week can maintain quality of life and safety compared to the conventional thrice weekly schedule. Participants in the study will be randomly assigned to receive either incremental haemodialysis starting at two sessions per week or conventional haemodialysis starting at three sessions per week. This international, multicenter randomized trial will recruit 372 adults beginning haemodialysis for kidney failure. The study will compare the two treatment schedules over time to see if the incremental approach preserves patient health and kidney function while reducing treatment burden and costs. During the trial, participants' quality of life will be carefully assessed using kidney disease-specific questionnaires six months after starting dialysis. Researchers will monitor the safety, practicality, and cost-effectiveness of the incremental dialysis method. The study will provide important data on whether this less intensive treatment schedule can benefit patients and families by lowering physical and financial burdens, reducing early mortality, and improving dialysis capacity.

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 evaluating the safety and effectiveness of selinexor as a maintenance treatment for patients with p53 wild-type endometrial carcinoma who have responded to platinum-based chemotherapy. This phase 3 trial will enroll 276 adults who have achieved either a partial or complete response after at least 12 weeks of treatment. The goal is to understand if selinexor can help prevent cancer from progressing in these patients. Participants will be randomly assigned to receive either selinexor tablets or matching placebo tablets by mouth. Selinexor is given as 60 mg doses, consisting of three 20 mg tablets. Treatment will begin 3 to 8 weeks after completing platinum chemotherapy. This is a double-blind study, meaning neither the participants nor the researchers will know who receives selinexor or placebo during the trial. During the study, participants will be regularly assessed for disease progression using standardized criteria called RECIST v1.1. Investigators will monitor progression-free survival from the time of randomization until either disease worsens or death occurs, up to 34 months. Participants will also have evaluations to check their health status and organ function throughout the trial to ensure safety and treatment adherence.

Researchers are studying how coronary artery plaque develops and changes over time in people with melanoma who have been treated with immune checkpoint inhibitors (ICIs). This prospective observational study aims to understand the natural progression of coronary atherosclerosis in this group. The study is being conducted at various sites across Australia and focuses on adults aged 40 years and older with melanoma at any stage who have received or are planned to receive ICI treatment. Participants will be monitored primarily for 18 months to assess the burden and composition of coronary plaque. The study involves imaging assessments, specifically coronary computed tomography angiography (CTCA), to evaluate the state of coronary arteries. No investigational treatments are administered as this is an observational study focusing on natural disease progression. During the study, participants will undergo follow-up CTCA scans and other assessments to monitor coronary artery health. Researchers will collect data on coronary plaque characteristics and progression while monitoring the participants' adherence to the protocol over the study duration. Safety and eligibility will be continuously assessed, and participants may be followed for up to 18 months to understand long-term outcomes related to coronary atherosclerosis in melanoma patients treated with ICIs.

Researchers are evaluating treatment options for adults with metastatic colorectal cancer that has a specific KRAS p.G12C mutation. The study compares progression-free survival in patients who have not received prior treatment. The trial is a Phase 3, multicenter, randomized, open-label study focusing on this particular mutation to improve outcomes in this patient group. Participants will receive one of two treatment combinations. One group will receive sotorasib (an oral drug), panitumumab (given via intravenous infusion every two weeks), and the FOLFIRI regimen—a combination of irinotecan, leucovorin, and 5-fluorouracil administered intravenously every two weeks. The other group will receive FOLFIRI with or without bevacizumab-awwb, which is also given intravenously every two weeks. Treatments continue according to the study schedule to assess effectiveness. Throughout the study, participants will be monitored for progression-free survival using standard criteria (RECIST v1.1) for up to about three years. Researchers will assess tumor response and disease progression to evaluate treatment effects. Participants will undergo regular evaluations to monitor organ function and overall health status during the study period.