Wenatchee

Researchers are evaluating the effectiveness and safety of two treatments, rilvegostomig and pembrolizumab, each combined with platinum-based doublet chemotherapy, as first-line therapy for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. The study is a Phase III, randomized, double-blind trial conducted globally at multiple centers. It focuses on patients with tumors expressing PD-L1 at 1% or higher and aims to compare these treatment combinations in this specific lung cancer population. Participants will be randomly assigned to one of two groups. One group receives rilvegostomig intravenously on Day 1 of each 21-day cycle, combined with platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed, followed by maintenance rilvegostomig plus pemetrexed monotherapy. The other group receives pembrolizumab intravenously on the same schedule with the same chemotherapy drugs, followed by pembrolizumab plus pemetrexed maintenance. Chemotherapy is given for up to four cycles. During the study, participants will be monitored for overall survival and progression-free survival for up to approximately five years. Researchers will also assess response rates, duration of response, pharmacokinetics, immunogenicity, and patient-reported physical function and quality of life. Safety will be carefully tracked throughout the study. The trial began in late 2024 and is expected to conclude around March 2030.

Researchers are evaluating the efficacy and safety of rilvegostomig combined with platinum-based chemotherapy compared to pembrolizumab combined with the same chemotherapy for first-line treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) at 1% or higher. This Phase III, randomized, double-blind, global study focuses on patients with squamous mNSCLC without actionable genomic mutations and assesses these treatments over approximately five years. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle, combined with carboplatin and paclitaxel or nab-paclitaxel chemotherapy. Chemotherapy is given up to 4 cycles, with nab-paclitaxel administered on Days 1, 8, and 15 of each cycle. After chemotherapy, patients continue with the assigned immunotherapy drug. The study compares these two treatment regimens as first-line therapy. During the study, participants undergo regular assessments including imaging to measure tumor response, survival, and disease progression up to about five years. Researchers also monitor physical functioning, quality of life, lung cancer symptoms, and drug pharmacokinetics and immunogenicity. Safety is closely followed, and overall survival and progression-free survival are the primary outcomes measured to evaluate the treatments' impact.

Researchers are conducting a Phase 2 clinical trial to evaluate the safety and effectiveness of several investigational treatments for chronic weight management in adults with obesity or overweight. This master protocol study includes multiple intervention-specific appendices (ISAs) that allow for independent assessment of each treatment as they become available. The study aims to establish entry criteria and report results after all ISAs are completed. Participants will be randomly assigned to receive one of several treatments or a placebo. These treatments include LY3305677, LY3841136, tirzepatide, LY3549492, LY3532226, macupatide, and eloralintide, administered either by subcutaneous injection or orally, depending on the specific ISA. Each ISA provides detailed analysis of its respective intervention. During the study, participants will be monitored from baseline through week 6 to assess how many are allocated to each ISA. The trial uses a double-blind design to ensure unbiased results. Participants will be assessed regularly throughout their involvement, which lasts until the completion of all ISAs. Safety and efficacy data will be collected and analyzed throughout the trial.

Researchers are evaluating the safety, immune response, and preliminary clinical efficacy of a candidate vaccine for urinary tract infections (UTIs) in adults aged 18 to 64 years. This trial focuses on adults generally for safety and immune response, and specifically on females with a history of at least one confirmed E. coli UTI within the past year for clinical efficacy. The study includes two parts: an initial dose-escalation safety phase and a proof-of-principle efficacy phase, designed to establish the highest tolerated dose and evaluate the vaccine's impact on UTI occurrence. Participants receive one of several vaccine dose formulations or placebo administered by injection on Day 1 and Day 61. Part 1 involves healthy male and female adults and tests increasing antigen doses for safety. After safety review, Part 2 enrolls females with previous E. coli UTIs to assess vaccine efficacy compared to placebo over a 12-month period. The vaccine is given intramuscularly following a 0 and 2 months schedule. Throughout the study, participants are monitored for side effects at the injection site and systemic reactions during the first week after each dose, as well as for any adverse events up to 426 days from the first dose. Blood tests, pregnancy monitoring, and clinical exams are conducted. The main outcome measures include the frequency of adverse events and the rate of urine culture confirmed UTIs in females during the follow-up period. Participants are followed closely for safety and immune response, with the trial lasting over a year from initial vaccination.

Researchers are evaluating solrikitug, a biological treatment, in people with chronic obstructive pulmonary disease (COPD) to assess its safety, tolerability, and how the body processes and responds to the drug. This 12-week, randomized, double-blind, placebo-controlled Phase 2 study aims to understand the effects of two different doses of solrikitug compared to a placebo, all given alongside standard COPD treatments. The study will enroll about 171 participants diagnosed with COPD who have elevated blood eosinophil levels. Participants will be randomly assigned to receive either a high dose or low dose of solrikitug or a placebo, delivered by subcutaneous injection at the study sites over a 12-week treatment period. After the treatment phase, there will be a 16-week follow-up period to monitor longer-term effects and safety. The injections are given under medical supervision during scheduled visits. During the study, participants will undergo assessments including blood tests to measure eosinophil counts and lung function tests such as FEV1. Researchers will track adverse events and serious adverse events throughout the treatment and follow-up periods. The total participation time will be approximately 28 weeks, including treatment and post-treatment observation.

Researchers are evaluating the efficacy and safety of ifinatamab deruxtecan (I-DXd) in people with various recurrent or metastatic solid tumors, including endometrial cancer, head and neck squamous cell carcinoma, pancreatic ductal adenocarcinoma, colorectal cancer, hepatocellular carcinoma, adenocarcinomas of the esophagus, gastroesophageal junction and stomach, urothelial carcinoma, ovarian cancer, cervical cancer, biliary tract cancer, HER2-low and HER2 immunohistochemistry 0 breast cancer, and cutaneous melanoma. This Phase 1B/2 study is divided into two parts, Stage 1 and Stage 2, with safety and efficacy data guiding progression between stages. A safety run-in phase will assess I-DXd tolerability specifically in hepatocellular carcinoma. Participants receive intravenous infusions of I-DXd, typically at 12 mg/kg, except for hepatocellular carcinoma where dosing is determined separately. The treatment is given to participants who have been previously treated with one or more systemic therapies for their tumor type. Each tumor type forms a separate cohort, and participants receive the study drug in repeated cycles as per protocol. Throughout the study, participants will be monitored for tumor response, safety, and side effects. Assessments include imaging scans to measure tumors, laboratory tests, and evaluations of adverse events. Pharmacokinetic analyses will measure drug concentrations over time. The primary outcome is the objective response rate, with follow-up lasting up to approximately 57 months. Safety data are collected up to 47 days after the last dose, and long-term monitoring includes survival and disease progression evaluations.

Researchers are evaluating a new medicine called GSK5764227 to see how well it works, how safe it is, and how the body processes it in adults worldwide who have advanced gastrointestinal cancers that cannot be removed by surgery and who have already received treatment. This trial is a Phase 1b/2 study focusing on participants with advanced, unresectable, or metastatic gastrointestinal tumors, including colorectal and pancreatic adenocarcinomas. Participants will receive GSK5764227 alone or in combination with other treatments, with different dosing groups depending on the type of cancer. The study is randomized and open-label, meaning participants will be assigned to one of several dosing groups without blinding. Treatment effects, safety, and drug levels will be monitored over a period of up to about 37 months. Throughout the trial, participants will undergo regular assessments including tumor measurements, blood tests for organ function and drug levels, vital sign monitoring, and evaluation of side effects. Researchers will track tumor response, progression-free survival, adverse events, and changes in clinical and laboratory parameters. The total study participation may last up to approximately 37 months, including follow-up periods to assess long-term effects and safety.

Researchers are studying muvalaplin to see if it can reduce the risk of major heart problems in adults with high levels of lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. This Phase 3 trial is designed to provide strong evidence by comparing muvalaplin to a placebo in a large group of participants over several years. The study is sponsored by Eli Lilly and Company and focuses on adults with atherosclerotic cardiovascular disease or those at risk for it. Participants will be randomly assigned to receive either muvalaplin or a placebo, both taken by mouth. The trial is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. The study will last about 5.25 years, during which participants will be monitored closely. The primary goal is to measure the time until the first major adverse cardiac event occurs, including heart attacks and strokes. During the study, participants will have regular visits for assessments, including blood tests to measure lipoprotein(a) levels and pharmacokinetics of muvalaplin over the first 96 weeks. Researchers will track the occurrence of cardiovascular events, deaths, and healthcare resource use annually. Safety and adherence will be monitored throughout the study to ensure participant well-being and accurate data collection.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with rilvegostomig or rilvegostomig alone, compared to pembrolizumab alone, as first-line treatments for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have high PD-L1 expression (tumor cell 50% or greater) and no actionable genomic alterations. This Phase III, randomized, open-label global study aims to improve treatment options for this patient group. Participants will be randomly assigned to one of three groups: one receiving Dato-DXd plus rilvegostomig, another receiving rilvegostomig alone, and the third receiving pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study compares these therapies to see which is more effective and safe as a first-line treatment. During the study, participants will undergo regular assessments including tumor evaluations, biomarker testing, and symptom questionnaires. Researchers will monitor progression-free survival and overall survival over approximately four to six years, along with other measures such as response rate, duration of response, physical functioning, and quality of life. Safety and pharmacokinetics will also be evaluated to understand how the treatments affect participants over the long term.

Researchers are evaluating the effectiveness and safety of different drug combinations as first-line treatment for adults with unresectable, locally advanced, or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) cancer. The trial focuses on participants with tumors exhibiting PD-L1 CPS scores of 1 or higher in the main group, and those with PD-L1 CPS less than 1 in an exploratory group. This phase 3 clinical trial compares the triplet therapy including trastuzumab deruxtecan, a fluoropyrimidine, and pembrolizumab against the standard care chemotherapy combined with trastuzumab and pembrolizumab. Participants are randomly assigned to one of four treatment groups. In the main cohort, one group receives trastuzumab deruxtecan with fluoropyrimidine and pembrolizumab, while the other receives trastuzumab plus platinum-based chemotherapy and pembrolizumab. The exploratory cohort compares trastuzumab deruxtecan plus fluoropyrimidine against trastuzumab with platinum-based chemotherapy. The drugs are administered intravenously every three weeks, with chemotherapy options including 5-FU, capecitabine, cisplatin, or oxaliplatin depending on the group. During the study, participants undergo regular assessments including imaging scans like CT or MRI to measure tumor response based on RECIST criteria. Heart function is monitored with left ventricular ejection fraction (LVEF) measurements before randomization, and tissue samples are collected to confirm HER2 and PD-L1 status. The primary outcome is progression-free survival measured up to 59 months, while overall survival is a key secondary outcome. Participants are followed closely throughout the trial to evaluate treatment effects and safety.