Gorlice

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating the safety and effectiveness of calderasib combined with pembrolizumab as a first treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation and a PD-L1 tumor proportion score of 50% or higher. This Phase 3 trial aims to test if the combination of calderasib and pembrolizumab improves progression-free survival and overall survival compared to pembrolizumab with a placebo. Participants receive oral calderasib tablets or placebo along with pembrolizumab given by intravenous infusion. The study compares these two treatment groups to see which provides better outcomes. Treatments continue during the study, and there are no additional interventions described beyond these drugs. During the trial, participants undergo regular assessments including scans and tests to monitor their cancer's progression and overall health. The main outcomes measured are progression-free survival for up to about 42 months and overall survival for up to about 56 months. Safety is monitored throughout, and participants are followed for several years to evaluate long-term effects of the treatments.

Researchers are evaluating the effects of intravenous ferric carboxymaltose (FCM) compared to placebo in patients who recently experienced an acute myocardial infarction (AMI) and have iron deficiency. This phase 4, multicenter, randomized, double-blind, placebo-controlled trial aims to assess whether FCM impacts mortality, heart failure events, serum NT-proBNP levels, and quality of life over a follow-up period of up to 36 months. The study specifically looks at the number and timing of heart failure events, changes in heart failure biomarkers, and quality of life using the EQ-5D questionnaire.

Researchers are evaluating a phase 3 study of pembrolizumab combined with carboplatin and a taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT) in adults with metastatic squamous non-small cell lung cancer. The study aims to determine if adding sac-TMT maintenance to pembrolizumab improves overall survival compared to pembrolizumab alone. Participants have confirmed stage IV squamous NSCLC and measurable disease. All participants first receive an induction phase of four cycles lasting 21 days each. During induction, they receive pembrolizumab every 3 weeks plus carboplatin every 3 weeks, along with either paclitaxel every 3 weeks or weekly nab-paclitaxel. After induction, participants are randomly assigned to continue pembrolizumab maintenance alone or pembrolizumab combined with sac-TMT maintenance. Treatments are given by intravenous infusion. Participants undergo scans to measure tumor response and are monitored for side effects and overall health. Researchers assess overall survival up to about 50 months. Organ function, adverse events, and performance status are regularly evaluated before and during the study. The study includes safety monitoring and follows participants through their treatment and maintenance phases.

Researchers are evaluating how well seltorexant works and its safety as an added treatment to antidepressants in adults and elderly participants who have major depressive disorder with insomnia symptoms (MDDIS). The study focuses on people who have not responded adequately to current antidepressant therapy with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). This Phase 3 trial aims to assess the improvement of depressive symptoms and the maintenance effect of seltorexant compared to a placebo. Participants will receive either seltorexant or a matching placebo taken orally alongside their current antidepressant medication, which includes SSRIs or SNRIs. The study is divided into two parts: Part 1 evaluates changes in depression severity after 43 days, while Part 2 monitors the time to relapse for up to nearly three years in participants who achieved a stable response. Participants must continue their stable antidepressant dose during the study. During the study, participants will be assessed using the Montgomery-Asberg Depression Rating Scale to measure changes in depression symptoms and monitored for relapse over time. Safety and tolerability will also be evaluated throughout. The total participation includes an initial treatment phase and an extended maintenance phase, allowing researchers to understand both short-term and long-term effects of seltorexant as an adjunctive therapy.

Researchers are evaluating ITI-1284 as an additional treatment for adults with Generalized Anxiety Disorder (GAD) who have not responded well to their current GAD treatment. This Phase 2, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness, safety, and tolerability of ITI-1284 in this population. Participants must meet specific diagnostic criteria for moderate or severe GAD and have shown inadequate improvement from at least one approved GAD medication. The study consists of three periods: a screening phase lasting up to 3 weeks to confirm eligibility and allow for withdrawal of prohibited medications; a 6-week double-blind treatment period where participants are randomly assigned to receive ITI-1284 at 10 mg, ITI-1284 at 20 mg, or a placebo, all administered once daily as sublingual tablets; and a 1-week safety follow-up period to monitor participants after treatment ends. During the study, participants will be closely monitored with assessments including the Hamilton Anxiety Rating Scale at week 6 to measure anxiety levels. Other evaluations include clinical interviews and safety checks to ensure participant well-being. The study tracks treatment adherence and collects data on the safety and tolerability of ITI-1284 throughout the treatment and follow-up periods.