Fukuyama

Researchers are comparing two treatment combinations for adults with advanced nonsquamous non-small cell lung cancer NSCLC that have a specific KRAS p.G12C mutation and are negative for PD-L1 expression. The study aims to evaluate progression-free survival and overall survival between participants receiving sotorasib with platinum doublet chemotherapy and those receiving pembrolizumab with platinum doublet chemotherapy. This phase 3, randomized, open-label trial is led by Amgen and includes participants with stage IV or advanced stage IIIBC NSCLC. Participants will be randomly assigned to receive either sotorasib orally combined with carboplatin and pemetrexed, or pembrolizumab intravenously combined with the same chemotherapy drugs. These treatments are given as front-line therapy. The study includes a treatment period with these drug combinations and monitoring for outcomes such as response rates and quality of life over several years. During the study, participants will be regularly assessed through various measures including survival status, tumor response, and quality-of-life questionnaires focusing on lung cancer symptoms. Researchers will monitor safety by tracking adverse events, vital signs, and laboratory tests. Treatment concentrations of sotorasib will also be measured up to 64 days after starting. The total study duration includes follow-up for up to approximately 5.5 years to fully evaluate treatment effects and outcomes.

Non-small cell lung cancer NSCLC is a disease where cancer cells grow uncontrollably in lung tissues. This trial aims to compare the investigational drug telisotuzumab vedotin with docetaxel to see which works better and to assess the safety of telisotuzumab vedotin in adults with previously treated NSCLC that overexpresses the c-Met protein. The study is a Phase 3 global trial involving about 768 participants at around 330 sites. Participants will be randomly assigned to receive either telisotuzumab vedotin by intravenous infusion every 2 weeks or docetaxel by intravenous infusion every 3 weeks. Treatment continues until specific criteria for stopping the study drug are met. After the study concludes, those who benefit may have access to continued treatment through extensions or rollover studies. During the trial, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, and side effect monitoring. Questionnaires will be completed to assess physical functioning and quality of life. Researchers will measure outcomes like progression-free survival and overall survival over up to about 39 months, with some secondary outcomes assessed up to approximately 58 months.

Researchers are evaluating elritercept for its ability to reduce the need for red blood cell RBC transfusions and its safety compared to epoetin alfa in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who require regular blood transfusions. The study aims to understand if elritercept improves tiredness, lowers transfusion burden, enhances quality of life, and elicits an immune response. Participants receive either elritercept or epoetin alfa injections. Elritercept is given as a subcutaneous injection starting at 3.75 mgkg every 4 weeks, with possible dose increases to 5.0 mgkg. Epoetin alfa is administered as a subcutaneous injection starting at 450 IUkg once weekly, with possible dose escalation up to 1050 IUkg. The study follows participants for approximately 5 years to monitor treatment effects and safety. During the trial, participants are regularly assessed for transfusion independence, hemoglobin levels, fatigue, quality of life, and hematological improvements. Researchers monitor blood samples for drug concentration and immune response. Safety is evaluated through medical history, lab tests, and adverse event tracking. The main outcome is the proportion of participants achieving RBC transfusion independence for at least 12 weeks during the first 24 weeks. The study uses questionnaires and clinical assessments to measure fatigue and quality of life.

Researchers are comparing the effectiveness of two different combinations of immunotherapy drugs with chemotherapy for adults with stage IV or recurrent non-squamous non-small cell lung cancer that has PD-L1 expression of 1% or higher. This phase 3, randomized study focuses on participants who have not previously received systemic treatment for advanced disease. The goal is to determine which combination better improves overall survival and other outcomes in this patient group. Participants will be randomly assigned to receive either Nivolumab plus Relatlimab combined with chemotherapy or Pembrolizumab combined with chemotherapy. The chemotherapy drugs used include Carboplatin, Pemetrexed, or Cisplatin, given in specified doses on scheduled days. Treatment is given as first-line therapy for their cancer, with dosing details managed throughout the study period. During the study, participants will undergo imaging scans like CT or MRI to measure disease status, and blood tests to monitor safety and side effects. The main outcome measured is overall survival over up to five years, along with progression-free survival, response rates, duration of response, and adverse events. Researchers will also assess symptoms related to lung cancer over two years. Participants are monitored regularly to track these outcomes and ensure safety throughout the study duration, which may last several years.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Researchers are evaluating the efficacy of the drug RO7837195 compared to a placebo in adults with moderately to severely active ulcerative colitis UC who have not responded well to conventional or advanced treatments. This Phase IIb study aims to assess the safety, pharmacokinetics, and clinical effects of RO7837195 in this patient group. The study is sponsored by Genentech, Inc. and focuses on treatment outcomes including clinical remission at Week 12. Participants undergo a screening period lasting up to 5 weeks, followed by a 12-week induction phase where some receive RO7837195 and others receive a placebo. After this, all participants enter a 40-week active treatment extension phase receiving RO7837195 regardless of their initial response. This design allows comparison during induction and continued treatment for all in the extension phase. Safety follow-up occurs after the last dose of study treatment. Throughout the trial, participants will be monitored for clinical remission, response, and endoscopic improvements at Week 12, as well as adverse events and drug concentration levels up to Week 65. The study includes regular evaluations such as clinical assessments and laboratory tests to track treatment effects and safety. Total participation can last up to approximately 57 weeks, covering screening, treatment, and follow-up periods.

Researchers are evaluating the safety and effectiveness of tezepelumab in children aged 5 to under 12 years with severe uncontrolled asthma. These children are already on medium to high doses of inhaled corticosteroids and at least one other asthma controller medication. The study is a phase 3, randomized, double-blind, placebo-controlled trial aimed at assessing tezepelumabs impact on asthma control and safety in this pediatric population. Participants will be randomly assigned in a 21 ratio to receive either subcutaneous injections of tezepelumab or a matching placebo over a 52-week double-blind treatment period. Before this, there is a 4 to 6 week screening and run-in period. After the treatment phase, there is a 12-week off-treatment follow-up for those not continuing. Additionally, an optional 104-week open-label extension allows eligible participants to receive tezepelumab, followed by another 12-week post-treatment follow-up. Throughout the study, participants will undergo regular assessments including lung function tests, asthma control questionnaires, symptom diaries, and blood tests to measure inflammation and immune response. Researchers will monitor asthma exacerbations, medication use, quality of life, and any side effects. Safety will be tracked during treatment and follow-up periods, with total study involvement potentially lasting over three years for those in the extension phase.

Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are evaluating the effect and safety of orforglipron taken once daily in adults with Fontaine Stage II peripheral arterial disease PAD who experience symptoms such as intermittent claudication. This phase 3 trial aims to understand how the drug affects walking ability and symptom relief over a period of about 58 weeks. The study is sponsored by Eli Lilly and Company and involves participants with confirmed PAD and reduced ankle brachial index ABI. Participants are randomly assigned to receive either orforglipron or a placebo in a double-blind design. Participants will take the study drug or placebo orally once daily. The study includes two groups one receiving orforglipron, and the other receiving a placebo. The treatment period lasts for approximately 52 weeks, during which participants will be monitored closely. This design allows comparison of the drugs effects against placebo on walking distance, symptoms, and quality of life measures. During the study, participants will undergo assessments including measuring their maximum walking distance, pain-free walking distance, and performance in a six-minute walk test at baseline and after 52 weeks. Questionnaires evaluating vascular quality of life and blood tests measuring inflammatory markers and blood pressure will also be collected. Safety and symptom relief will be monitored throughout the nearly one-year participation, helping to determine the drugs impact on PAD symptoms and overall vascular health.

This research investigates response-guided therapy after neoadjuvant endocrine treatment to improve adjuvant care in premenopausal women with hormone receptor-positive, HER2-negative breast cancer. It focuses on optimizing treatment by identifying patients who may safely avoid chemotherapy based on their response to endocrine therapy. The study is a multicenter, randomized phase III trial aiming to compare this approach to standard surgery followed by adjuvant therapy. Participants are randomly assigned to one of two groups one group undergoes upfront breast surgery followed by adjuvant systemic therapy based on pathological findings, and the other group receives neoadjuvant endocrine therapy with an aromatase inhibitor and ovarian function suppression for three months before surgery. Adjuvant treatments vary depending on the patients Oncotype DX recurrence score and endocrine therapy response, with options including endocrine therapy alone, chemotherapy combined with endocrine therapy, or tamoxifen. During the study, participants are monitored for outcomes such as event-free survival, overall survival, relapse-free survival, and distant recurrence-free survival over up to 12 years. Researchers also assess quality of life, safety, and the rate of endocrine therapy use without chemotherapy. The study involves long-term follow-up to evaluate the effectiveness of response-guided therapy in improving treatment decisions for premenopausal women with this breast cancer subtype.