Takarazuka

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

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.