Neihu District

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

This research aims to evaluate the antiviral effects of S-337395 compared with a placebo in adults who are not hospitalized but have respiratory syncytial virus RSV infection and are at high risk of progressing to severe disease. Participants must start treatment within 72 hours of showing RSV symptoms. The study is a Phase 2b trial and involves adults with specific risk factors such as older age and chronic lung or cardiovascular disease. Participants will be randomly assigned to receive either a high dose or low dose of S-337395, or a matching placebo. The treatment is given orally twice daily for up to 5 days. The study is double-blind, meaning neither participants nor researchers know which treatment is being administered during the trial. Throughout the study, participants will be monitored closely with assessments including nasal swabs to measure RSV RNA levels at several time points up to day 6. Researchers will also track symptoms using questionnaires and record any side effects up to 28 days. Blood samples will be collected to measure drug levels, and safety will be monitored throughout the study, which runs until December 2026.

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer NSCLC who do not achieve a complete response after initial therapy. This Phase 3 trial compares the combination of sacituzumab tirumotecan plus pembrolizumab against pembrolizumab alone, focusing on disease-free survival assessed by a blinded independent central review. The study is sponsored by Merck Sharp & Dohme LLC and targets participants with specific stages of NSCLC who have undergone neoadjuvant therapy and surgery but still have residual disease. Participants first receive neoadjuvant therapy consisting of pembrolizumab combined with double-platinum chemotherapy tailored to the tumor type for up to 12 weeks before surgery. After surgery, those not achieving pathological complete response are assigned to either receive sacituzumab tirumotecan infusions every two weeks for up to 24 weeks alongside pembrolizumab monotherapy every six weeks for approximately 42 weeks, or pembrolizumab monotherapy alone on the same schedule. Rescue medications to manage infusion reactions may be given as needed during the study. Throughout the trial, participants undergo assessments including radiological scans, tumor tissue analysis for markers like PD-L1 and TROP2, and monitoring for adverse events and quality of life changes. Key outcomes include disease-free survival, overall survival, distant metastasis-free survival, and lung cancer-specific survival, with evaluations continuing for up to nearly 10 years. Safety and tolerability are closely monitored, and questionnaires assess physical functioning, symptoms like cough and chest pain, and overall health status during and after treatment.

Researchers are evaluating the safety, tolerability, and anticancer activity of CHO-H01 in adults with relapsed or refractory CD20-positive non-Hodgkins lymphoma. This study includes two parts Phase 1 focuses on finding the maximum tolerated and recommended doses of CHO-H01 alone, while Phase 2a assesses the combination of CHO-H01 with lenalidomide in patients with low-grade lymphoma types. The study aims to better understand treatment options for this condition, sponsored by Cho Pharma Inc. In Phase 1, participants receive intravenous infusions of CHO-H01 once weekly for 4 weeks during the first 28-day cycle, then once every 21-day cycle for up to 6 cycles or until disease progression. Dose levels range from 0.5 mgkg to 12 mgkg in escalating cohorts. After confirming the recommended dose, Phase 2a begins, where subjects receive the recommended dose of CHO-H01 combined with daily oral lenalidomide for 21 days in each 28-day cycle. Participants will undergo regular assessments including monitoring for adverse events, dose-limiting toxicities, and tumor response over approximately 16 months. Researchers will measure serum drug concentrations, immune responses, and clinical outcomes such as time to progression and survival. Safety and efficacy are closely followed through laboratory tests, imaging, and clinical evaluations during and after treatment to understand the benefits and risks of these therapies.

Researchers are evaluating whether artificial intelligence-enabled electrocardiography AI-ECG can identify people at high risk for left ventricular dysfunction and if early use of guideline-directed medical therapies can reduce this risk. This multicenter retrospective study uses data from Taiwans healthcare system collected between 2016 and 2024, focusing on patients with preserved left ventricular systolic function at baseline. The study applies AI-ECG risk stratification and emulates a target trial to assess therapy impacts on heart function decline. The study compares patients starting guideline-directed medical therapiessuch as angiotensin converting enzyme inhibitors ACEi, angiotensin II receptor blockers ARB, beta-blockers, and sodium-glucose cotransporter 2 SGLT2 inhibitorsagainst those not receiving these treatments. AI-ECG models developed from over 50,000 paired ECG and echocardiogram recordings identify high-risk individuals despite normal initial ejection fraction. The study evaluates the association between early preventive medication use and incident left ventricular dysfunction. Participants must have had both an ECG and echocardiogram within 90 days and preserved heart pumping function initially. Researchers will review medical records, medication prescriptions, ECGs, and echocardiography results. The main measurement is the rate of left ventricular ejection fraction dropping to 40% or below during up to 10 years of follow-up. Safety and outcomes will be monitored using real-world data, with analyses exploring robustness across clinical settings and patient profiles.