A Randomized Open-label Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy
Brief description of study
This is Phase 2/3 study testing a new medicine called iza-bren (also known as izalontamab brengitecan or BL-B01D1) for treating advanced lung cancer that has a specific mutation called EGFRmt. Iza-bren works in a special way: it targets two proteins, EGFR and HER3, which are often involved in cancer growth. It delivers a medicine that can kill cancer cells directly to the tumor. The goal of this study is to find the best dose of iza-bren and see how well it works compared to standard chemotherapy (a combination of platinum and pemetrexed).
This study has two parts: phase 2 and phase 3. In Phase 2, the patients are randomly put into one of three groups. Once enough patients have been treated in Phase 2, the study will choose the best dose of iza-bren and move to Phase 3. In Phase 3, patients will randomly get either the chosen dose of iza-bren or standard chemotherapy. This phase will compare how well iza-bren works, how safe it is, and how well people can tolerate it, compared to the usual chemotherapy treatment (platinum-pemetrexed) for EGFRmt lung cancer. This part of the study is for patients whose cancer keeps growing even after using another medicine called EGFR-TKI. All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer is responding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.
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