Nankoku

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 evaluating how well vortioxetine, given at doses of 10 mg or 20 mg per day, works compared to a placebo to treat depression symptoms in Japanese teenagers aged 12 to 17 years diagnosed with Major Depressive Disorder MDD. The study focuses on assessing both the effectiveness and side effects of vortioxetine in this young population. Participants will take the study drug orally once daily for 14 weeks. The initial dose of vortioxetine starts at 10 mg per day and may be increased to 20 mg per day based on the study plan. Some participants will receive vortioxetine while others will receive a placebo, and the trial is randomized and double-blind to fairly compare outcomes. During the approximately 20-week study, participants will first spend up to 2 weeks screening for eligibility, then take vortioxetine or placebo for 14 weeks, followed by a 4-week period to monitor any side effects after treatment ends. Participants will visit their clinic 13 times for assessments, which include rating scales for depression symptoms and other health evaluations. Researchers will monitor changes in depression severity using tools like the Children Depression Rating Scale and assess safety through clinical observations and tests.

Researchers are evaluating IMVT-1402 in a global, randomized, double-blind, placebo-controlled Phase 2b study for adults with Graves disease GD who remain hyperthyroid despite antithyroid drug ATD treatment. The study aims to assess the efficacy, safety, and tolerability of IMVT-1402 in this population. Participants will receive one of two doses of IMVT-1402 or a placebo for 26 weeks. The study includes two experimental groups with different doses of IMVT-1402 and a placebo comparator group. Treatments are given over the same 26-week period to evaluate their effects. During the study, participants will be monitored to see if they become euthyroid and are able to stop ATD by Week 26. Researchers will measure thyroid hormone levels such as triiodothyronine T3 and free thyroxine FT4 at various time points, including Weeks 2, 4, and 26. Safety and tolerability will also be assessed throughout the trial, which is expected to complete in May 2027.

Researchers are evaluating the clinical benefit of combining Navlimetostat BMS-986504, a selective MTA-cooperative inhibitor of PRMT5, with pembrolizumab and chemotherapy compared to placebo plus pembrolizumab and chemotherapy. This study focuses on participants with first-line metastatic non-small cell lung cancer NSCLC who have a homozygous MTAP deletion. The trial is a randomized Phase 23 study aimed at advancing treatment options for this specific lung cancer group. Participants will receive one of several combinations Navlimetostat plus pembrolizumab and chemotherapy, or placebo plus pembrolizumab and chemotherapy. Chemotherapy drugs involved may include cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel, given at specified doses on certain days. The study uses a quadruple-masked, parallel design with multiple treatment arms to compare these regimens. During the study, participants will be monitored for progression-free survival and overall survival up to five years. Researchers will assess tumor response, disease control, duration and time to response, and safety through adverse event reporting and laboratory tests. The study includes detailed follow-up to evaluate efficacy and safety outcomes over the long term, with a primary completion date in 2031.

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 safety and effectiveness of combining KarXT and KarX-EC as a treatment for psychosis associated with Alzheimers disease. This Phase 3 randomized, double-blind, placebo-controlled trial aims to address psychotic symptoms such as hallucinations and delusions in patients aged 55 to 90 diagnosed with Alzheimers disease according to recent criteria. The study is sponsored by Bristol-Myers Squibb and uses a parallel group design to compare the investigational drug combination against placebo. Participants will be randomly assigned to receive either the combination of KarXT plus KarX-EC or a matching placebo, with specified doses given on set days. The treatment period lasts approximately 14 weeks, during which safety and efficacy are closely monitored. The trial assesses changes from baseline in neuropsychiatric symptoms and other clinical measures using standardized scales and questionnaires. During the study, participants will undergo various assessments including clinical evaluations, laboratory tests, brain imaging review, and symptom rating scales such as the Neuropsychiatric Inventory-Clinician and Clinical Global Impressions-Severity. Researchers will also monitor adverse events and other health indicators up to about week 14. The total participation duration spans from screening through treatment completion and safety follow-up to evaluate the overall impact and safety profile of the treatments.

Researchers are evaluating the effectiveness and safety of combining standard chemotherapy and bevacizumab with or without the drug INCA33890 for the first treatment of metastatic microsatellite stable colorectal cancer. This is a Phase 3 randomized trial focusing on patients with stage IV colorectal adenocarcinoma that cannot be cured by surgery. Participants receive either INCA33890 or a placebo, both given alongside bevacizumab and FOLFOX chemotherapy at doses defined by the study protocol. Treatment is administered as part of the first-line therapy for metastatic disease, with participants randomly assigned to one of the two groups. During the study, participants will be regularly monitored through imaging and clinical assessments to measure progression-free survival for up to three years. Additional outcomes include overall survival, response to treatment, side effects, and quality of life measures up to four years. Safety and treatment effects will be closely followed throughout the trial period.

Researchers are evaluating the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL who have previously been treated with a covalent Bruton tyrosine kinase inhibitor cBTKi. The study is a phase 3, open-label, randomized trial sponsored by BeOne Medicines, aiming to assess treatment options for these patients. Participants are randomly assigned to receive either BGB-16673 or pirtobrutinib, both taken orally. This parallel assignment design compares these two drugs directly. The treatments continue with monitoring up to approximately three years to observe progression-free survival and other outcomes. The study began in September 2025 and is expected to complete in April 2028. During the trial, participants will undergo regular assessments including imaging scans to measure disease status, quality of life questionnaires, and monitoring for adverse events. Outcomes such as overall survival, response rates, duration of response, and time to next treatment are tracked. Safety and quality of life will be evaluated throughout the study period, which may last up to about three years for each participant.

Researchers are evaluating the safety and effectiveness of belzutifan as a single therapy for people with advanced pheochromocytomaparaganglioma, pancreatic neuroendocrine tumors, von Hippel-Lindau disease-related tumors, advanced wild-type gastrointestinal stromal tumors, or other advanced solid tumors with genetic changes related to hypoxia inducible factor-2 alpha. This phase 2 study focuses on measuring the objective response rate using standardized criteria reviewed by an independent central panel. Participants will receive oral belzutifan at a dose of 120 mg once daily. Treatment continues until the disease progresses or the participant chooses to stop. The study does not include a comparison group and follows a single-group design. The study period can last up to about 5.5 years to assess treatment effects and safety over time. During the study, participants will have regular assessments including imaging scans reviewed centrally to evaluate tumor response. Researchers will track outcomes such as duration of response, time to response, disease control rate, progression-free survival, overall survival, and any adverse events experienced. Safety and treatment tolerability will be monitored throughout the study. Participants are expected to remain in the study for several years to gather long-term data on belzutifans effects.

Researchers are evaluating a new medicine called NNC6019-0001 for people with transthyretin amyloid cardiomyopathy ATTR-CM, a condition that affects the heart and leads to heart failure. This Phase 3 study compares NNC6019-0001 with a placebo to see if it can reduce the risk of heart-related death and illness. Participants will continue their usual heart treatments throughout the study. Participants will receive either NNC6019-0001 or a matching placebo through intravenous IV infusion. Both groups may also continue their standard heart failure treatments as advised by their doctors. The study is randomized and blinded so that neither participants nor researchers know who receives the medicine or placebo. Treatment and follow-up will last up to about 4 years. During the study, participants will have regular assessments including heart function tests, questionnaires about heart failure symptoms and quality of life, and walking tests to measure physical ability. Researchers will monitor heart-related events such as hospitalizations and urgent visits for heart failure, as well as death from cardiovascular causes. Safety labs and biomarker tests will be done. The main outcome is a combination of cardiovascular deaths and recurrent heart problems measured from the start to the end of the study.