Hudson

Researchers are evaluating a new medicine called PF-08634404 in adults with advanced Renal Cell Carcinoma (RCC), a type of kidney cancer that has spread locally or to other parts of the body. This phase 1b/2 study aims to assess the safety and how well PF-08634404 works alone or combined with other anticancer medicines in treating this advanced kidney cancer. Participants must be adults who have not yet received treatment for their advanced RCC. Participants will receive PF-08634404 either by itself or together with other anticancer drugs through intravenous (IV) infusions administered at clinical study sites by trained medical staff. The study includes treatment periods where the medicine is given as a concentrate solution for infusion, with combinations involving two other anticancer drugs also evaluated. All treatments occur under close medical supervision at the study centers. During the study, participants will have regular assessments including measuring tumor response using RECIST v1.1 criteria for up to approximately three years. Researchers will monitor safety by tracking treatment-emergent and serious adverse events, as well as dose-limiting toxicities during the evaluation period. Participants' health will be closely followed through clinical and laboratory tests throughout the study to understand the medicine's effects and safety profile.

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.