Ostrava 3

Researchers are evaluating treatments for people with advanced non-small cell lung cancer NSCLC that have specific genetic changes called HER2 mutations. This lung cancer has spread or cannot be controlled with current treatments. The study aims to compare how well a drug called sevabertinib works and how safe it is compared to standard treatment for this type of cancer. Participants will receive either sevabertinib tablets twice daily or standard treatment consisting of pembrolizumab combined with platinum-based chemotherapy given every 21 days by infusion. Those on standard treatment who experience disease progression may switch to sevabertinib. Treatment continues as long as participants benefit and do not have severe side effects or until they or their doctor decide to stop. During the study, participants will have imaging scans like CT, PET, MRI, and X-rays to monitor cancer spread. Doctors will also perform health checks including blood and urine tests, heart monitoring with ECG, pregnancy tests for women, and ask about symptoms or side effects. The main measure is progression-free survival assessed up to about 2 years, with additional outcomes related to survival, response rates, side effects, and quality of life followed up to 4 years.

Researchers are evaluating the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea OSA who are not using positive airway pressure PAP therapy and have overweight or obesity. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how this treatment affects OSA severity and related health measures in this specific population. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is administered throughout the 52-week period. The trial compares these two groups in parallel to assess the effects of the medication against placebo. During the study, participants will undergo various assessments including polysomnography to measure apnea-hypopnea index AHI, body weight monitoring, blood pressure checks, and patient-reported sleep impairment questionnaires. Safety and tolerability will be monitored, and researchers will track changes in markers such as sleep apnea severity, body weight, inflammation, and blood pressure over the 52 weeks of treatment.

Researchers are evaluating the efficacy and safety of maridebart cafraglutide compared to placebo over 52 weeks in adults with obstructive sleep apnea OSA who are receiving positive airway pressure PAP therapy and have overweight or obesity. This Phase 3 trial aims to study the treatment effects in this specific population to improve management of OSA alongside current PAP therapy. Participants are randomly assigned to receive either maridebart cafraglutide or a placebo as subcutaneous injections. The study runs for 52 weeks, during which participants continue their PAP therapy while receiving the study drug or placebo. The trial includes a double-blind design to compare outcomes between the two groups over the treatment period. During the study, participants undergo various assessments including polysomnography to measure the Apnea-Hypopnea Index AHI, body weight measurements, blood pressure, blood tests for cholesterol, insulin, and glucose levels, as well as patient-reported sleep-related outcomes. Researchers monitor treatment-emergent adverse events and drug plasma levels, with evaluations occurring at multiple time points including weeks 24, 48, and 52. The total participation duration extends up to about 100 weeks for safety follow-up and outcome evaluation.

Researchers are evaluating pembrolizumab combined with carboplatin and taxane chemotherapy as a first-line treatment for metastatic squamous non-small cell lung cancer NSCLC. This phase 3 trial aims to compare overall survival between patients receiving pembrolizumab with maintenance sacituzumab tirumotecan sac-TMT and those receiving pembrolizumab alone during maintenance therapy. The study explores whether the addition of sac-TMT improves outcomes for patients with this type of lung cancer. Participants first undergo an induction phase of four cycles receiving pembrolizumab every 3 weeks along with carboplatin and either paclitaxel or nab-paclitaxel. After induction, they are randomly assigned to one of two maintenance groups pembrolizumab alone every 6 weeks for up to 96 weeks, or pembrolizumab combined with sac-TMT every 2 weeks until discontinuation criteria are met. The chemotherapy drugs are given intravenously during the induction phase, and maintenance treatments continue intravenously according to assigned groups. Throughout the study, participants will be monitored for overall survival as the primary outcome, with secondary outcomes including progression-free survival, adverse events, treatment discontinuations, and quality of life measures such as dyspnea, cough, and chest pain. Assessments include tumor scans to evaluate disease status, performance status checks, and patient-reported questionnaires on symptoms and health-related quality of life. Participants are followed for up to approximately 79 months to gather comprehensive safety and efficacy data, with ongoing monitoring by the research team.