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Chemotherapy and Cemiplimab with or without Alirocumab before Surgery for the Treatment of Lung Cancer in Patients with Stage IB-IIIA Non-small Cell Lung Cancer

Trial Status: active

This phase II trial compares the effect of adding alirocumab to chemotherapy plus cemiplimab versus chemotherapy plus cemiplimab alone prior to surgery for patients with stage IB-IIIA non-small cell lung cancer (NSCLC). Researchers want to know if combining alirocumab with cemiplimab can generate anti-tumor activity and clinical responses in these patients. Lung cancer in its earlier stages can sometimes be cured by surgery. However, there is still a significant chance that it will come back (relapse), and studies are being done to find ways to improve patients’ outcomes. One approach is to give anti-cancer drugs before surgery (called neoadjuvant therapy) to reduce the chances of a relapse. One of these drugs, known as alirocumab, is a PCSK9 inhibitor. PCSK9 inhibitors are a type of cholesterol-lowering drug. It works by lowering levels of low-density lipoprotein cholesterol (LDL-C), also known as “bad cholesterol” which may reduce cardiovascular events in patients with heart disease. Programmed cell death protein 1 (PD-1) inhibitors and programmed cell death 1 ligand (PD-L1) inhibitors, such as cemiplimab, are a group of anticancer drugs that block the activity of PD-1 and PD-L1 immune checkpoint proteins present on the surface of cells. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving alirocumab with chemotherapy and cemiplimab may be safe, tolerable and/or effective in treating patients with stage IB-IIIA NSCLC.