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Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

Researchers are conducting a three-part Phase 3 clinical trial to evaluate a potential new medicine called Sofetabart Mipitecan Sofe-M in people with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancers. The study focuses on patients with platinum-resistant cancer in Part A, meaning their disease worsened during or within six months of platinum-based chemotherapy, and platinum-sensitive cancer in Parts B and C, where disease remained controlled for more than six months after platinum treatment. The goal is to assess whether Sofe-M works better than current standard treatments and to understand its safety. Participants receive treatments administered intravenously. Part A compares Sofe-M to investigators choice of chemotherapy or Mirvetuximab Soravtansine MIRV. Parts B and C compare Sofe-M plus bevacizumab to platinum-based doublet chemotherapy plus bevacizumab. The study includes multiple chemotherapy options such as paclitaxel, topotecan, gemcitabine, and pegylated liposomal doxorubicin. Each participants involvement duration depends on their response to treatment. During the trial, participants undergo regular assessments including imaging to measure progression-free survival and overall survival. Researchers also track tumor marker responses, side effects, quality of life scores, and pharmacokinetics of Sofe-M. The study uses a randomized design without masking. Follow-up can last up to about 70 months, allowing for long-term safety and effectiveness monitoring.

Researchers are evaluating if a combination of atezolizumab and standard chemotherapy can improve treatment outcomes for patients with sensitive relapse Extensive-stage Small Cell Lung Cancer ES-SCLC who have progressed after first-line treatment with platinum-etoposide chemotherapy plus PD-L1 inhibitors like atezolizumab or durvalumab. This phase II trial is designed to find out if continuing PD-L1 inhibition along with rechallenge chemotherapy increases overall survival and to monitor medical problems participants may experience. Eligible patients receive induction treatment with atezolizumab 1200 mg given intravenously on day 1 every 3 weeks along with carboplatin and etoposide chemotherapy for up to 4 cycles. After induction, patients continue maintenance therapy with atezolizumab every 3 weeks for up to 18 cycles or one year. Treatment continues until disease progression, unacceptable side effects, patient choice, or loss of clinical benefit. The study spans an expected 45 months, including 24 months for recruitment, 15 months maximum treatment duration, and up to 6 months of follow-up. Participants visit the clinic every 3 weeks for treatment, checkups, and tests. Radiological assessments using CT scans are done at 6 weeks, 12 weeks, and then every 12 weeks to check treatment response. Researchers continuously monitor safety and adverse events during treatment. The primary outcome is overall survival over about one year, with additional measures including progression-free survival and the frequency of adverse events. Participants are closely observed throughout the study to evaluate treatment effects and safety.

Researchers are evaluating the use of ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy as the first treatment for people with metastatic non-small cell lung cancer NSCLC. This Phase 3, randomized, double-blind, multiregional study involves around 1600 patients divided into two groups based on NSCLC histology squamous and non-squamous. The main goals are to assess overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab or pembrolizumab along with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. The two histology groups will be analyzed separately to understand how each treatment works within these subtypes of NSCLC. This design helps compare the effects of the two treatment combinations. During the study, participants will be monitored for survival and disease progression over several years. Safety assessments include tracking side effects from the start of treatment through 30 to 90 days after the last dose or start of other cancer therapies, with follow-up lasting up to two years. The study includes regular evaluations to measure tumor response and overall health, ensuring comprehensive monitoring throughout the participation period.

Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches conventional right ventricular pacing, conduction system pacing such as His bundle or left bundle branch area pacing, cardiac resynchronization therapy CRT with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.

Researchers are evaluating a treatment approach for patients with metastatic pulmonary large-cell neuroendocrine carcinoma LCNEC who have not received prior therapy. This prospective multicenter phase II study aims to assess the combination of durvalumab with carboplatin and etoposide chemotherapy as a first-line treatment in this population. Participants will receive an induction phase of intravenous durvalumab 1500 mg on day 1, carboplatin AUC 5 on day 1, and etoposide 100 mgsqm on days 1-3 every three weeks for up to 4 cycles or until disease progression, unacceptable side effects, or other stopping reasons. Following this, patients enter a maintenance phase receiving durvalumab 1500 mg intravenously every 4 weeks for up to 24 additional courses, totaling 28 courses or 2 years of treatment, whichever comes first. Throughout the study, participants will undergo regular clinical assessments to monitor treatment effects, side effects, and disease status. Researchers will measure treatment efficacy using established criteria over one year. Safety and tolerability will also be closely tracked. The total duration of participant involvement may last up to 2 years or until disease progression or intolerable toxicity occurs.

Researchers are evaluating the addition of Atezolizumab to a chemotherapy regimen called FOLFOXIRI plus Bevacizumab as the first treatment for patients with metastatic colorectal cancer that has proficient mismatch repair pMMR and high Immunoscore IC. This phase III, open-label, randomized trial aims to compare how well this combination works in delaying cancer progression, known as Progression Free Survival PFS. Participants will be randomly assigned to one of two groups. One group receives FOLFOXIRI plus Bevacizumab treatment every two weeks for up to 8 cycles, followed by maintenance therapy with 5-FULV plus Bevacizumab until cancer progresses or side effects become unacceptable. The other group receives the same treatment plus Atezolizumab, with a similar schedule and maintenance phase including Atezolizumab. Treatments involve intravenous infusions of multiple drugs, and dosing times vary from 30 minutes to several hours depending on the drug and cycle number. During the study, participants will undergo regular assessments including tumor measurements, quality of life questionnaires, and monitoring for side effects. Researchers will track outcomes such as cancer response rates, toxicity, overall survival, and quality of life over periods up to 48 months. The study includes safety monitoring and follow-up until disease progression, unacceptable toxicity, or patient choice to stop treatment.

Researchers are conducting the HEROS study, a multi-center observational and prospective study in Italy, to investigate the current diagnostic and treatment approaches for HER2-mutated advanced non-small cell lung cancer NSCLC. This study works with the ATLAS project, which collects data from over 59 centers on newly diagnosed advanced NSCLC patients, to understand how common HER2 mutations are and how they are managed in routine clinical practice. Patients enrolled in the ATLAS project from September 2024 to September 2025 will be included to study the prevalence of HER2 mutations. Approximately 100 patients with HER2 mutations will be closely observed for secondary and exploratory objectives. Additionally, a subset of 25 centers will collect blood and tissue samples from available tumor sites to perform biomarker analyses, further exploring the biological characteristics of these cancers. Participants will be followed for 12 months after enrollment to track clinical information and outcomes. Data will be gathered from medical records and biomarker samples when available. The main measure of interest is the prevalence of HER2 mutations over one year. This observational study does not involve any investigational treatments, and participants will continue their usual care while contributing data to help improve understanding of HER2-mutated NSCLC.

Researchers are evaluating the management of acute and chronic osteomyelitis in patients with diabetic foot syndrome, focusing on infections localized in the forefoot. This prospective multicenter randomized trial compares the effectiveness and safety of a bioactive glass device S53P4 against standard surgical care practices. The goal is to assess healing rates and other outcomes related to bone infection treatment in specialized centers. Participants are randomly assigned to one of two groups. Group A receives surgical removal of the infected bone and soft tissue debridement, along with systemic antibiotics and optional bone substitutes except bioactive glasses. Group B undergoes similar debridement but preserves the bone cortex while replacing infected soft bone with the S53P4 bioactive glass according to its approved use. Both groups aim for primary wound closure and may have vacuum drainage placed postoperatively. Participants are followed closely after surgery with biweekly visits up to three months or until healing, and then at six and twelve months. Assessments include wound evaluation, x-rays, histopathology, laboratory tests, and quality of life and foot function questionnaires. Researchers monitor healing progression, complications such as reinfection, recurrence rates, and functional recovery. The primary outcome is the healing rate at six months, with additional measures including antibiotic duration, re-interventions, amputations, and surgery characteristics.

This trial studies adults with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer TNBC who are not eligible for PDL1 therapy based on PD-L1 negative disease. It is a Phase III, randomized, double-blind study comparing pumitamig with chemotherapy versus placebo with chemotherapy. The trial aims to evaluate the effects and safety of pumitamig in combination with chemotherapy for this patient group. Participants are randomly assigned to one of two groups one receives pumitamig plus a chemotherapy regimen chosen by their physician, and the other receives a matching placebo plus chemotherapy. Chemotherapy options include paclitaxelnab-paclitaxel, gemcitabine plus carboplatin, or eribulin, administered per standard care. The treatment period continues until disease progression, intolerable side effects, withdrawal, death, or trial end. After treatment, participants enter a safety follow-up for up to 90 days and a survival follow-up lasting until death, withdrawal, loss of contact, or sponsor decision. During the study, participants undergo screening lasting up to 28 days to confirm eligibility. They receive regular chemotherapy and study drug or placebo infusions during treatment. Researchers assess progression-free survival and overall survival up to about 32 and 49 months respectively. Other outcomes include response rates, quality of life, adverse events, and treatment tolerability. Safety monitoring continues after treatment, and survival is followed long-term. The total study participation can span several years depending on individual outcomes and follow-up.