Fountain Hill

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are evaluating pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy for treating participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). This Phase III, multisite, randomized, double-blinded trial aims to assess safety and efficacy in this population. The study includes two stages with different treatment and control arms and stratifies participants based on brain or liver metastases, smoking status, and geography. Participants will receive treatments administered by intravenous infusion, including pumitamig or atezolizumab combined with chemotherapy drugs etoposide and carboplatin, with the option to switch to cisplatin if carboplatin is not tolerated. Each stage consists of a screening period up to 21 days, followed by an induction and maintenance period lasting until confirmed disease progression, intolerable toxicity, withdrawal, study termination, or up to two years. After treatment, all participants enter a follow-up period including safety and survival visits. Throughout the study, participants undergo evaluations including assessments of overall survival for up to approximately 46 months. Researchers will monitor disease status, treatment toxicity, and participant health through scheduled visits. The study carefully tracks participant adherence and safety during treatment and follow-up to better understand the effects of the investigational therapies in ES-SCLC management.