La Florida

Researchers are evaluating the safety and effectiveness of telisotuzumab vedotin compared to docetaxel in adults with previously treated non-squamous non-small cell lung cancer (NSCLC) that overexpresses c-Met. This phase 3 study focuses on participants with advanced or metastatic NSCLC who have specific genetic markers and have progressed after prior therapies. The study aims to assess changes in disease activity and adverse events over time. Participants will be randomly assigned to receive either intravenous telisotuzumab vedotin every two weeks or intravenous docetaxel every three weeks. Treatment continues until predefined discontinuation criteria are met. Those who benefit from the study treatment may have the option to continue receiving it through an extension or rollover study. Approximately 698 adults will be enrolled worldwide at about 330 sites. During the study, participants will attend regular hospital or clinic visits for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure progression-free survival and overall survival for up to approximately 39 months. The study includes careful safety monitoring and evaluates the impact of treatment on disease progression and patient well-being.

Researchers are evaluating a new combination treatment of Sigvotatug Vedotin plus pembrolizumab compared to pembrolizumab alone in adults with non-small cell lung cancer (NSCLC) that has high levels of PD-L1 protein. This study focuses on participants with advanced or metastatic NSCLC (Stage 3 or 4) who have PD-L1 expression in at least 50% of their tumor cells. The purpose is to understand how well the combination works versus pembrolizumab alone as a first treatment option. All participants receive pembrolizumab through an intravenous infusion once every 6 weeks at the study clinic. Half of the participants will also receive Sigvotatug Vedotin as an intravenous infusion every 2 weeks along with pembrolizumab. Participants may continue pembrolizumab treatment for up to about two years, while those receiving Sigvotatug Vedotin can continue until their cancer no longer responds to the treatment. During the study, participants will have regular clinic visits where researchers monitor their health and response to treatment. The main outcomes measured include overall survival up to approximately two years and progression-free survival, which tracks the time until cancer worsens or death. Safety and side effects will be closely observed throughout the study period to understand the treatments' impact.