Villars Sur Glane

Researchers are evaluating the safety and effectiveness of Ifinatamab Deruxtecan (I-DXd) compared to treatment chosen by physicians for adults with relapsed extensive-stage small cell lung cancer (ES-SCLC). The study aims to find out if I-DXd can improve the objective response rate, meaning the proportion of patients whose cancer shrinks or disappears, and extend overall survival time compared to other treatments. Secondary goals include assessing safety, patient-reported outcomes, immune response to I-DXd, B7-H3 protein levels, and how the drug is processed in the body. Participants will receive either I-DXd at a dose of 12 mg/kg given intravenously on the first day of each 21-day treatment cycle or one of the physician's choice treatments including Topotecan, Amrubicin, or Lurbinectedin, administered according to local standards of care. The study is randomized and open-label, meaning treatments are assigned by chance and both patients and doctors know which treatment is given. During the study, participants will be closely monitored with tumor assessments to evaluate response and detect disease progression, safety evaluations, and quality of life questionnaires. The main outcomes measured are the objective response rate assessed by a blinded independent review and overall survival time, tracked for up to approximately five years after randomization. Researchers will also monitor for any adverse effects and collect health economics data to understand the broader impact of treatments.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating whether placing a special mesh during abdominal wall closure can prevent incisional hernias in patients who have undergone open abdominal aortic aneurysm repair. This retrospective observational study aims to find out if mesh reinforcement lowers the rate of incisional hernias and to assess the frequency of related postoperative complications by comparing patients who received mesh reinforcement to reported cases without mesh. The intervention involves placing a self-gripping polyester or composite mesh behind the abdominal muscles during surgery. This mesh is positioned carefully to cover the area without tension and is secured before closing the abdominal wall. The study includes patients who had this procedure between January 2019 and January 2024. Participants will have clinical follow-ups and abdominal ultrasounds to check for hernias. They will also complete quality-of-life questionnaires such as EQ-5D and PROMIS. The main outcome measured is the rate of incisional hernias, with results expected between January and April 2025. The study requires at least one year of postoperative follow-up for each participant.

Researchers are investigating a new drug called ALE.F02 to see if it can protect and preserve kidney function in people with antineutrophil cytoplasmic antibody (ANCA) associated vasculitis (AAV), which is an autoimmune disease where the body's immune system attacks its own small blood vessels, often affecting the kidneys. This Phase 2 trial aims to determine the safety, tolerability, and kidney-protective effects of ALE.F02 when added to standard therapy for rapidly progressive glomerulonephritis (RPGN) caused by AAV. Participants will be randomly assigned to one of four groups: standard treatment plus low, high, or maximum dose infusions of ALE.F02, or standard treatment plus placebo infusions. The treatment period lasts 24 weeks, starting on Day 1, during which participants receive 13 infusions alongside standard therapies such as Rituximab, Glucocorticoids, Cyclophosphamide, and other immunosuppressive agents. Kidney biopsies are performed before or during the study to assess kidney tissue, and lung CT scans are done to check for lung vasculitis at the beginning and at Week 24 if applicable. Throughout the study, participants undergo physical exams focusing on skin and existing conditions, blood and urine tests to monitor kidney function and drug levels, and tests for antibodies against the study drug. Urine pregnancy tests are done for females, and safety is monitored continuously. The main outcome measured is the safety and tolerability of continuous intravenous ALE.F02 infusion over about one year, alongside its effects on preserving kidney function in this patient population.