New investigational drug GSK5764227 for the treatment of recurrent or refractory small-cell lung cancer

Lung cancer develops when cells in the lungs multiply uncontrollably and form tumors. Small-cell lung cancer (SCLC) is considered aggressive and can spread throughout the body early in the course of the disease. Treatment depends on the extent of the disease. The disease is classified into three stages. In the very limited stage (VLD), the tumor is still small and confined to a limited area of the lung, so surgery or targeted radiation therapy aimed at completely removing the tumor may be possible. In the limited stage (LD), the cancer is confined to one lobe of the lung and nearby lymph nodes. A combination of chemotherapy and radiation therapy is an option in this case. In the extensive stage (ED), the cancer has already spread to other organs or distant lymph nodes (metastases), so local therapy is no longer an option, and systemic therapy—that is, chemotherapy and immunotherapy—is necessary instead. At this stage of the disease, the goal of treatment is disease control (palliative therapy), as it must be assumed that the tumor can no longer be cured. The standard treatment for ED-SCLC consists of a combination of chemotherapy and immunotherapy. If a recurrence of the disease is detected during treatment, it is referred to as a relapse; if the disease cannot be controlled with therapy, it is defined as refractory. If the disease progresses, a different chemotherapy drug is typically used (second-line therapy), most commonly topotecan. The study drug GSK5764227 could represent a new treatment option in this context. It is an antibody conjugated to a targeted chemotherapeutic agent (antibody-drug conjugate) that targets a surface receptor on cancer cells. The drug is not yet approved in Germany for the treatment of SCLC.

The goal of this Phase 3 study is to investigate the efficacy and safety of the study drug GSK5764227 compared to standard treatment with topotecan. Patients will be randomly assigned to two groups as part of the study. The study arm will receive the investigational drug GSK5764227, and the control arm will receive standard chemotherapy with topotecan. The study is open-label, meaning that both medical staff and patients know which drug is being administered. The primary endpoints of the study are the response rate to therapy and the overall survival rate after 55 weeks.

Women and men aged 18 and older with advanced small-cell lung cancer are eligible to participate in this study. The disease must have been previously treated (with at least one platinum-based systemic therapy combined with a PD-(L)1 inhibitor) and must have shown a recurrence or be uncontrollable (refractory).