Comparison of the new investigational drug Pumitamig with Durvalumab following combined chemotherapy and radiation therapy for inoperable, advanced non-small-cell lung cancer

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer. In stage 3, the cancer has spread within the lung and to nearby lymph nodes, but usually cannot be removed by surgery. In this situation, chemoradiation therapy is typically used, combining platinum-based chemotherapy with radiation therapy. Following this, maintenance (consolidation) therapy with the antibody durvalumab has become the standard of care. It blocks the PD-L1 protein and is thus intended to help the body’s own immune system recognize any remaining cancer cells. The study drug Pumitamig is a so-called bispecific antibody that blocks not only PD-L1 but also a vascular growth factor (VEGF-A). By simultaneously blocking PD-L1 and VEGF-A, the body’s immune system should be better able to recognize and fight cancer cells. At the same time, the formation of new blood vessels that supply the tumor with oxygen and nutrients is expected to be inhibited. Pumitamig has not yet been approved for the treatment of this disease.

The goal of this Phase 3 study is to investigate the efficacy and safety of the new active ingredient pumitamig following completion of chemoradiotherapy, compared to treatment with durvalumab. Patients will be randomly assigned to two groups. In the study arm, patients will receive Pumitamig, and in the control arm, treatment will consist of Durvalumab. Both drugs will be administered as an intravenous infusion. The study is open-label (not blinded), meaning that both the medical staff and the patients know which drug is being administered. Among the main objectives (primary endpoints) of the study is overall survival over a period of up to nine years.

Women and men aged 18 and older with non-non-small-cell lung cancer at inoperable stage 3 who have previously received at least two cycles of platinum-based chemotherapy combined with radiation therapy totaling at least 54 Gy and whose disease has not progressed since then are eligible to participate in this study. Patients with active autoimmune diseases, severe cardiovascular problems, or existing or recent inflammatory lung diseases are not eligible to participate.