Wakayama

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating the effectiveness of combining tarlatamab with durvalumab, carboplatin, and etoposide compared to the combination of durvalumab, carboplatin, and etoposide alone in treating patients with untreated extensive stage small-cell lung cancer ES-SCLC. The main goal is to see if the addition of tarlatamab can help patients live longer overall. This is a phase 3, open-label, randomized study conducted across multiple centers. Participants are assigned to one of two groups. One group receives tarlatamab combined with durvalumab, carboplatin, and etoposide for four treatment cycles, followed by maintenance treatment with tarlatamab and durvalumab. The other group receives durvalumab, carboplatin, and etoposide for four cycles, followed by durvalumab alone. All drugs are given as intravenous infusions. The study lasts up to approximately 3.5 to 4 years to assess survival and disease progression. During the study, participants will undergo regular assessments including evaluations of overall survival and progression-free survival. Other measures include response to treatment, disease control, duration of response, and monitoring for treatment-related adverse events. Blood tests will evaluate drug levels and antibody development. The research team will carefully monitor participants throughout the treatment and follow-up periods, keeping track of their health and any side effects.

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.

Researchers are evaluating the efficacy and safety of the combination of divarasib and pembrolizumab compared with pembrolizumab combined with pemetrexed and either carboplatin or cisplatin. This study focuses on adults with previously untreated, advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The goal is to assess these treatments as first-line options in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group will take divarasib orally once daily and receive pembrolizumab through an intravenous infusion every three weeks. The other group will receive pembrolizumab, pemetrexed, and either carboplatin or cisplatin via intravenous infusions every three weeks. Treatment continues with these schedules, following the study protocol for up to approximately five years of follow-up. During the study, participants will have regular assessments to monitor their health and response to treatment. These include imaging and clinical evaluations to measure progression-free survival and overall survival for up to five years. Researchers will also track quality of life, symptom changes, treatment side effects, and adverse events using questionnaires and patient-reported outcomes. Safety monitoring and detailed evaluations will help understand the effects of the treatments over the study duration.

Researchers are evaluating the safety, pharmacokinetics, and activity of divarasib either alone or combined with other anti-cancer treatments in adults with previously untreated advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. This study includes participants with locally advanced unresectable or metastatic NSCLC who have not received prior systemic treatment for their advanced disease. The trial is open-label and includes multiple phases to assess different dosing and combinations of therapies. Participants are assigned to different groups to receive divarasib daily by mouth, alone or combined with pembrolizumab given intravenously every three weeks. Some groups also receive a platinum-based chemotherapy carboplatin or cisplatin and pemetrexed alongside divarasib and pembrolizumab. Different dose levels of divarasib are being tested, with some participants randomized during an expansion phase to receive one of two combination dose levels. Treatment cycles last 21 days and treatments are given according to these schedules. Throughout the study, participants undergo regular monitoring for safety and treatment effects, including assessments of adverse events from baseline until 60 days after the last dose or until starting another cancer therapy. Researchers also evaluate response rates, duration of response, progression-free survival, and symptom changes over approximately five years. Tests include patient questionnaires about side effects and quality of life, as well as measurements of divarasib levels in the body. The study aims to identify recommended doses and assess responses, including in the central nervous system, with ongoing safety monitoring during and after treatment.

Researchers are evaluating the effectiveness and safety of current standard treatments for adults with active systemic lupus erythematosus SLE, including lupus nephritis, who have not responded adequately to glucocorticoids and at least two immunosuppressant therapies. The study focuses on participants with ongoing active disease despite prior treatments, aiming to better understand treatment outcomes in this population. The study is observational and sponsored by Bristol-Myers Squibb. Participants will continue to receive their current standard of care treatments as prescribed, which may include biologic therapies and other immunosuppressants, according to product labels and treatment guidelines. Those with lupus nephritis must have had a recent renal biopsy confirming specific kidney involvement. The study observes participants over time without altering their treatment, collecting data on disease activity and response. During the study, participants will be monitored regularly for up to five years. Assessments include clinical evaluations, laboratory tests, and disease activity questionnaires to track remission status, kidney function, disease flare-ups, and fatigue levels. The primary outcome is the number of participants achieving remission at six months. Secondary outcomes include long-term remission, kidney response, disease activity states, and patient-reported fatigue. Safety and treatment response duration will also be recorded throughout the study period.

Researchers are evaluating the anti-tumor activity and safety of amivantamab administered as a subcutaneous co-formulation with recombinant human hyaluronidase PH20 rHuPH20 in participants with advanced or metastatic solid tumors, including non-small cell lung cancer NSCLC with specific EGFR mutations. This study focuses on various cohorts, some receiving combination treatments, and others monitoring safety of the co-formulation alone. Participants receive amivantamab subcutaneously at doses adjusted by body weight, combined with treatments such as lazertinib orally, pemetrexed and carboplatin intravenously, or anticoagulants as appropriate. Dosing schedules vary by cohort, typically involving initial frequent doses followed by maintenance cycles every 21 or 28 days. Some participants may enter a long-term extension phase to continue receiving study treatments. During the study, participants undergo evaluations including tumor response assessments using RECIST 1.1 criteria, safety monitoring through adverse event tracking, laboratory tests, and patient-reported outcomes. Follow-up assessments occur up to several years depending on cohort. Participants eligibility includes confirmed NSCLC with specific EGFR mutations and adequate organ function, with monitoring of treatment safety and efficacy throughout their participation.

Researchers are studying the effectiveness and safety of eloralintide in adults who are obese or overweight but do not have type 2 diabetes. This Phase 3 trial aims to understand how eloralintide affects body weight and related health measures over a long period. The study includes a main phase and an extension phase for those with prediabetes to evaluate ongoing effects. Participants are randomly assigned to receive one of four doses of eloralintide or a placebo, all given by subcutaneous injection once weekly. The main phase lasts about 75 weeks, and participants with prediabetes may continue in an extension phase for an additional two years. This structure allows researchers to assess both short-term and longer-term outcomes. During the study, participants will have regular visits to measure body weight, body fat, waist size, blood pressure, blood markers like triglycerides and insulin, and quality of life questionnaires. Safety and treatment effects are monitored throughout. The main outcome is the percent change in body weight from the start to week 64, with follow-up continuing up to week 191 for some. Overall participation can last up to several years depending on the participants health status.