Beppu

This research observes patients with Paroxysmal Nocturnal Hemoglobinuria who are treated with Fabhalta capsules. It is a multicenter, single-arm, non-interventional study designed to monitor drug use and safety over time. The study uses a central registration and all-case surveillance system to collect data. Participants will be observed for 48 weeks after starting Fabhalta treatment. If treatment stops within this period, any adverse events and use of other medications will be tracked up to 30 days after the last treatment day. There are no additional interventions or comparison groups in this study. During the study, researchers will monitor the occurrence of infections and other adverse events through case report forms. Participants' health and drug usage will be recorded throughout the observation period. The total participation lasts for 48 weeks, focusing on safety and drug use in real-world settings.

Researchers are evaluating whether a new medicine called PF-08634404 combined with chemotherapy is more effective than the current standard treatment, pembrolizumab with chemotherapy, for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase 3 study focuses on adults 18 years and older with squamous or non-squamous NSCLC who are not candidates for surgery or curative chemoradiotherapy and have not received prior treatment for advanced disease. The study excludes participants with known actionable genomic alterations and aims to compare overall survival and progression-free survival over approximately 39 and 32 months, respectively. Participants are assigned to two parts based on their tumor type: squamous NSCLC patients in Part 1 and non-squamous NSCLC patients in Part 2. Within each part, participants are randomly assigned to receive either the experimental treatment PF-08634404 or the control treatment pembrolizumab, each combined with a chemotherapy regimen tailored to tumor type. Treatments are given via intravenous infusions in cycles, followed by maintenance therapy with either monotherapy or combination therapy depending on the study part. Treatment continues as long as it is beneficial and side effects remain manageable. During the study, participants will have regular visits for treatment administration and health evaluations. Cancer response will be monitored with tests every 6 weeks for the first 48 weeks and then every 12 weeks afterward. Researchers will assess overall survival and progression-free survival, ensuring thorough monitoring of participants' health and treatment effects throughout the study period.