Thun

Researchers are evaluating sacituzumab tirumotecan alone and in combination with pembrolizumab compared to treatment chosen by the physician in participants with hormone receptor positivehuman epidermal growth factor receptor-2 negative HRHER2- breast cancer that is locally advanced, unresectable, or metastatic. The study aims to see if these treatments improve progression-free survival compared to standard physician-chosen therapies. This is a Phase 3 clinical trial assessing advanced breast cancer treatments. Participants are randomly assigned to one of three groups sacituzumab tirumotecan alone given by intravenous infusion every two weeks until disease progression or discontinuation sacituzumab tirumotecan plus pembrolizumab with sacituzumab tirumotecan given every two weeks and pembrolizumab given every six weeks for up to about two years or treatment chosen by the physician, which may include various chemotherapy options such as paclitaxel, nab-paclitaxel, capecitabine, or liposomal doxorubicin, administered with schedules depending on the drug. Treatments continue until disease progression or discontinuation. During the study, participants will have regular assessments including imaging to evaluate progression-free survival, overall survival, response rates, and quality of life measures using questionnaires. Safety is monitored by tracking adverse events and treatment discontinuations. The primary outcome is measured up to approximately 38 months, with additional secondary outcomes followed up to about 77 months. Participants are followed closely through study visits and evaluations throughout the trial period.

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 research aims to evaluate the effectiveness of AZD5335 compared to standard treatments in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study focuses on whether AZD5335 improves progression-free survival PFS among participants with either high or low levels of folate receptor alpha FR. Approximately 1100 adult women will be enrolled and divided into two groups based on their FR levels. Participants will be randomized within each group to receive either AZD5335 or the relevant standard treatment. Those with high FR levels will receive AZD5335 or mirvetuximab soravtansine, while those with low FR levels will receive AZD5335 or a chemotherapy agent chosen by the investigator, including paclitaxel, pegylated liposomal doxorubicin, or topotecan. Treatments are given intravenously, and participants will continue treatment until disease progression or other reasons for stopping. During the study, participants will undergo regular tumor assessments to monitor disease status. Researchers will follow all participants over time to evaluate overall survival. Safety and efficacy data will be reviewed periodically by an independent committee. The primary outcome is progression-free survival, measured for up to about five years. The study completion is expected by late 2029.

Chronic leg and foot ulcers are wounds that do not heal properly over 4 to 8 weeks despite standard care, often due to vascular problems like chronic venous insufficiency and peripheral artery disease. These conditions reduce blood flow, limiting oxygen and nutrients needed for healing, and cause ongoing inflammation and infection. This trial evaluates a new combined optical and magnetic stimulation COMS therapy alongside standard care to improve healing, pain, quality of life, and economic outcomes for patients with venous leg ulcers, including those with arterial complications. Participants will be randomly assigned to receive either standard care alone or standard care plus COMS therapy. Standard care includes wound cleaning, dressing changes, debridement, analgesics as needed, and compression therapy according to guidelines. The COMS treatment is applied 2 to 3 times per week for at least 8 weeks using a specialized device during standard care procedures. If patients receive care at home, trained caregivers will perform these treatments. During the 24-week study, participants will have regular assessments to monitor wound healing, pain, quality of life, and ulcer recurrence. Researchers will measure the percent reduction in wound area as the primary outcome after 24 weeks, along with complete wound closure and time to healing. Safety and device usability will also be evaluated. The study is single-blinded with data assessors unaware of group assignments and includes multiple clinical sites across several countries.

Researchers are evaluating the effect of continued nutritional support after hospital discharge compared to usual care in medical patients at nutritional risk. This trial focuses on adults who have experienced malnutrition, a condition linked to higher risks of death, rehospitalization, and loss of function, especially among elderly and multi-ill patients. Previous studies showed that in-hospital nutritional support helps reduce complications and mortality, but the long-term benefits after discharge remain unclear. Participants are randomly assigned to one of two groups. The intervention group receives customized nutritional support from an experienced dietician to meet their individual energy and protein needs, including oral nutritional supplements as needed. The control group receives general advice on healthy eating habits at discharge without ongoing nutritional support. Follow-up includes regular phone calls every 2 to 4 weeks to monitor adherence and adjust dietary plans as necessary. During the study, participants are monitored for up to three years. Researchers assess key outcomes such as time to death from any cause, hospital readmissions, major complications, and changes in functional status using the Barthel index. Quality of life is measured with the European Quality of Life 5 Dimensions index and a visual-analogue scale at regular intervals by phone. This comprehensive follow-up helps determine whether sustained nutritional support after discharge improves long-term health and recovery.

Researchers are studying whether adding magnesium to the standard chemo-immunotherapy can improve treatment outcomes in patients with advanced non-small cell lung cancer NSCLC that is unresectable stage III or metastatic stage IV. Magnesium plays a key role in immune function, and its levels often drop during chemotherapy, which may affect how well immune therapies work. This trial is a randomized, double-blind, placebo-controlled phase IIIII study assessing if magnesium supplementation enhances immune response and clinical results. Participants are randomly assigned to one of two groups one receiving standard platinum-based chemo-immunotherapy plus oral magnesium tablets three times a day and intravenous magnesium sulfate on chemotherapy days the other receiving the same chemo-immunotherapy plus matching placebo tablets and intravenous infusions. The study monitors magnesium levels centrally through blood and urine samples. The phase II part focuses on safety and progression-free survival, and if successful, the study expands seamlessly into phase III, which measures overall survival. During the trial, patients undergo regular assessments including monitoring of adverse events, immune-related biomarkers, magnesium levels, and quality of life. Data is collected through validated electronic forms with quality checks and source verification to ensure accuracy. Participants are followed for up to 10 years to evaluate progression-free survival, overall survival, event-free survival, and treatment tolerability. This study explores a cost-effective way to potentially improve immune control of NSCLC by addressing magnesium deficiency caused by chemotherapy.

Researchers are evaluating treatment options for older and frail patients aged 70 and above with metastatic non-small cell lung cancer NSCLC who have PD-L1 expression below 50%. This study focuses on comparing reduced-dose chemotherapy combined with cemiplimab against cemiplimab alone. The goal is to find a treatment that is both effective and better tolerated in this vulnerable group, who often face greater risks of side effects and poor tolerance to standard-dose chemotherapy. This randomized, open-label phase II trial assigns participants to one of two groups one receives reduced-dose platinum-doublet chemotherapy plus cemiplimab, and the other receives cemiplimab alone. The chemotherapy regimens vary slightly depending on cancer histology and are given every three weeks for four cycles, followed by maintenance cemiplimab treatment for up to two years or until disease progression or unacceptable side effects. Participants who experience disease progression may be eligible to switch to the combination therapy. Participants undergo regular assessments including CT scans and CNS imaging every 6 to 12 weeks, quality of life questionnaires, and geriatric-specific tests such as hand-grip strength at set intervals during treatment and follow-up. Researchers measure progression-free survival, overall survival, tumor response, treatment side effects, and patient-reported outcomes to evaluate treatment effectiveness and safety. The study aims to improve treatment decisions for older patients often excluded from clinical trials, ensuring their quality of life and functional status are considered.

Researchers are evaluating the benefits and safety of adding sacituzumab tirumotecan to pembrolizumab compared to treatment chosen by a physician in adults with triple-negative breast cancer TNBC who have already received pre-surgery therapy but did not achieve a complete response at surgery. This Phase 3, randomized, open-label trial aims to see if the combination treatment improves invasive disease-free survival compared to current standard options. The study is sponsored by Merck Sharp & Dohme LLC and focuses on patients who need additional therapy after surgery. Participants in one group receive sacituzumab tirumotecan by intravenous infusion every two weeks combined with pembrolizumab every six weeks for a total of 24 weeks. They also receive pre-medication such as antihistamines, H2 antagonists, acetaminophen, and dexamethasone before sacituzumab tirumotecan infusions. The comparison group receives pembrolizumab every six weeks alone or with oral capecitabine twice daily on specific schedules for 24 weeks. The study uses random assignment to these treatment groups and follows participants for long periods. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess invasive disease-free survival for up to about 77 months and track overall survival, recurrence, and quality of life measures for up to around 101 months. Safety will be monitored by recording adverse events and any treatment discontinuations due to side effects. The study includes detailed evaluations of physical functioning, fatigue, and role functioning using questionnaires. Participation lasts several years with ongoing assessments to evaluate long-term outcomes and safety.

Researchers are studying whether weekly acupuncture sessions over eight weeks can help reduce psychological distress in breast cancer patients who have recently finished their main treatments. This trial focuses on women transitioning into survivorship, a vulnerable period marked by increased stress, fear of cancer returning, and feelings of isolation. The study compares acupuncture with standard care, aiming to see if acupuncture lowers stress and improves quality of life and other mental health factors. Participants are randomly assigned to receive either eight weekly acupuncture sessions or standard supportive care, which may include psychosocial support or support groups. Those in the control group will have access to acupuncture after completing the initial assessment period. The acupuncture involves both body and ear treatments delivered once a week during the intervention. During the study, participants will undergo assessments of distress, quality of life, anxiety, depression, resilience, fatigue, cognitive function, therapy adherence, and any adverse events. Distress levels are measured before and after each acupuncture session, with primary outcomes evaluated after the eight-week intervention. The study will monitor these effects to understand the potential benefits and impacts of acupuncture during breast cancer survivorship.

Researchers are evaluating treatments for patients with previously untreated follicular lymphoma who have a FLIPI score of 2 to 5. This phase III, randomized, open-label trial compares the combination of mosunetuzumab and lenalidomide with anti-CD20 monoclonal antibody plus chemotherapy. The study aims to assess the efficacy and safety of these treatments in managing this type of lymphoma. Participants enter a screening period lasting up to 6 weeks before randomization and treatment. Those randomized to the experimental arm receive mosunetuzumab with step-up dosing followed by lenalidomide over an induction phase of about 11 months, then a maintenance phase lasting up to 17 months, totaling around 30 months of treatment. The control arm includes different combinations of anti-CD20 antibodies with chemotherapy drugs CHOP or bendamustine over induction phases of about 5 months, followed by maintenance for up to 22 months, also totaling about 30 months. Patients are not allowed to switch from control to experimental treatments. Throughout the study, participants undergo regular follow-up visits for up to 7 years after the last patient is randomized. Follow-up includes assessments every 3 months for the first two years, then every 6 months for three years, and yearly thereafter. Researchers monitor progression-free survival, overall survival, response rates, adverse events, and other health measures. The total study duration is expected to be around 10 years from the start of enrollment to final follow-up.