Johnson City

Researchers are evaluating the efficacy and safety of combining durvalumab and domvanalimab compared to durvalumab plus placebo in adults with locally advanced Stage III, unresectable non-small cell lung cancer NSCLC whose disease has not progressed after definitive platinum-based concurrent chemoradiotherapy cCRT. This Phase III, randomized, double-blind, placebo-controlled, international study aims to provide new insights into treatment options for this patient population. Participants will receive either durvalumab and domvanalimab or durvalumab plus placebo as intravenous infusions every four weeks, beginning on Day 1 and continuing for up to 12 months. The study includes two groups one receiving the combination of durvalumab and domvanalimab, and the other receiving durvalumab with a placebo. Both treatments are given through infusion to assess their effects on disease progression and safety. During the trial, participants will undergo regular assessments including monitoring progression-free survival for up to 8 years after randomization. Other measures include overall survival, response rates, duration of response, and various time-to-event outcomes related to disease progression and symptom deterioration. Researchers will also evaluate drug concentrations and immune responses approximately 12 weeks after the last dose. Participants can expect scheduled visits for infusions and evaluations as part of this long-term study.

Researchers are studying how children with developmental language disorder DLD learn new words in context, especially while reading. This study aims to combine two strategies that improve contextual word learning in typically developing children to see how well they work for children with DLD. Understanding this can help improve vocabulary growth and support better academic and social outcomes for affected children. The study involves a behavioral intervention called the Contextual Word Learning Intervention, which includes metalinguistic training focused on semantic inferencing and exposure to texts with varying semantic diversity. Participants will take part in three weekly sessions where they engage in repeated meaning generation, explanations, and receive feedback. Words are presented in different contexts ranging from no diversity to high diversity to test how context affects learning. Children participating will be assessed before and after the intervention on their ability to infer meanings and retain new word semantics. The main outcome measure is the Measure of Semantic Knowledge, administered one week after sessions. The study includes children aged 7 to 11, both typically developing and those with DLD, with monitoring of any hearing or vision impairments. The results will guide future trials and improve practices for supporting vocabulary learning in children.

Researchers are evaluating the effect of dalcetrapib on cardiovascular risk in people recently hospitalized for acute coronary syndrome ACS who have a specific genetic profile AA genotype. This phase 3, randomized, double-blind, placebo-controlled study focuses on adults aged 45 years and older, aiming to assess the time to first occurrence of fatal or non-fatal myocardial infarction over an average of 30 months from randomization. The study will continue until around 200 participants experience a primary event, or until stopped at an interim analysis. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily, two 300 mg tablets or matching placebo tablets once daily. Screening includes genetic testing for the AA genotype using a specialized Genotype Assay Test. Enrollment can begin during hospitalization or after discharge, but randomization must occur within 12 weeks of the ACS event. After randomization, follow-up visits will be virtual when possible or in clinic every three months until the study ends. Assessments will continue every three months for participants who stop the study medication early. Participants will undergo medical history review and genetic testing before enrollment. During the study, researchers will monitor cardiovascular events such as heart attacks and strokes through regular assessments every three months. Safety evaluations and collection of study endpoints will continue for the duration of participation, which may last approximately 30 months or until the study stops. This includes ongoing monitoring for adverse effects and overall health status.