Frenchs Forest

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating the safety, tolerability, how the body processes the drug (pharmacokinetics), and early antitumor effects of BG-C0979 alone or combined with tislelizumab in adults with selected advanced solid tumors. This study includes Phase 1a, which involves dose escalation and safety expansion, and Phase 1b, focusing on dose expansion to gather more information about the treatment's effects and safety. Participants may receive BG-C0979 administered by intravenous infusion alone or together with tislelizumab, also given by intravenous infusion. The study is divided into parts, including Phase 1a for dose escalation and safety evaluation, and Phase 1b for dose optimization and expansion, either with BG-C0979 alone or combined with tislelizumab. During the study, participants will be monitored for side effects and treatment responses for up to approximately 24 months. Researchers will assess the number of participants experiencing adverse events, determine the maximum tolerated dose and recommended doses for further study, and evaluate overall response rates. Participants will have measurable tumors and stable performance status, and their organ functions will be checked to ensure safety throughout the study.

Researchers are evaluating the safety, tolerability, how the body processes, and early anti-cancer effects of a new drug called BG-C477. The study includes participants with advanced solid tumors that have been previously treated or for whom no standard treatment exists. This trial is a Phase 1a/b, first-in-human study conducted by BeOne Medicines, formerly BeiGene, to better understand BG-C477 alone and combined with other cancer treatments. Participants will receive BG-C477 intravenously, either by itself or combined with other anticancer agents such as Tislelizumab or chemotherapy given according to local guidelines. The study includes dose escalation to find the maximum tolerated or administered dose, followed by dose expansion to evaluate recommended doses. This process may last up to approximately two years, with specific focus on safety, dosing, and preliminary effectiveness. During the study, participants will be monitored for side effects and treatment responses through clinical assessments, laboratory tests, and imaging to measure tumor changes. Researchers will collect samples from tumors and track adverse events from the first dose until 30 days after the last dose, with follow-up lasting up to two years. The primary outcomes include safety measurements, dose recommendations, and overall response rate to treatment.

Researchers are investigating the effects of low-dose intracoronary thrombolytic therapy in patients who experience ST-elevation myocardial infarction (STEMI), a type of heart attack caused by a blood clot blocking the heart's blood vessels. The study focuses on patients with impaired microcirculatory perfusion, identified by an elevated Index of Microcirculatory Resistance (IMR) after angioplasty. This damage to the heart's small vessels is linked to worse clinical outcomes, and the trial seeks to determine if dissolving clots inside the coronary artery can reduce this damage and improve patient outcomes. After patients receive angioplasty and a drug-eluting stent, their IMR is measured. Those with IMR above 32 are randomly assigned to receive either low-dose tenecteplase, a clot-dissolving drug, or a placebo of sterile water directly into the coronary artery. Patients with IMR 32 or below are monitored in a registry. The tenecteplase dose is one-third of the systemic weight-based dose, infused intracoronarily. Cardiac MRI scans are performed 3-7 days after the procedure and again at 6 months for randomized patients, with follow-up visits scheduled at 30 days, 6, 12, and 24 months. Throughout the study, participants undergo cardiac enzyme tests and clinical assessments. The primary outcomes measured include rates of cardiovascular death and rehospitalization for heart failure at 24 months, as well as the size of the heart attack and bleeding within the heart muscle at 6 months. The study carefully monitors safety and treatment effects through imaging and clinical follow-up to evaluate whether low-dose tenecteplase can improve long-term heart function after STEMI.

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

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.