The purpose of this study is to compare the efficacy of the investigational drug and placebo (an inactive substance) in combination with chemotherapy and concurrent radiotherapy in your disease and collect safety information on the investigational drug in combination with chemotherapy and concurrent radiotherapy. An investigational drug is one that has not been approved by the Food and Drug Administration (FDA). The investigational drug used in the study is HLX10 (hereinafter referred to as the investigational drug or study drug), which is a humanized monoclonal antibody that acts on programmed cell death protein-1 (PD-1). Antibodies are common proteins that can be synthesized in the laboratory and used in treatment. PD-1 is a protein on the surfaces of immune cells and can inhibit the killing of cancer cells by immune cells. The investigational drug acts on PD-1 to prevent it from inhibiting immune cells, thereby allowing immune cells to attack cancer cells.
Molecular, cellular, and animal non-clinical studies showed that the investigational drug can suppress tumor growth. Currently, early phase clinical trials are ongoing. You should discuss this with your study doctor for clarity.
The placebo is an injection that does not contain the active ingredient and cannot be distinguished by visual inspection. The chemotherapeutic drugs are carboplatin/cisplatin and etoposide, which have been used in clinical practices. While carboplatin/cisplatin and etoposide are approved by the FDA for treatment of small cell lung cancer, they are not approved for use in combination with the study drug; therefore, their use in this study is investigational.