Phase 2 Trial of Neoadjuvant KRAS G12C directed therapy with Adagrasib (MRTX849) with or without Nivolumab in Resectable Non-Small Cell Lung Cancer (Neo-KAN)

The purpose of this study is to assess the benefits and risks of the study drug, adagrasib, when given either by itself or with another drug, nivolumab, to participants with non-small cell lung cancer and a specific cancer mutation, called KRAS G12C, and whether the study drug or the combination may treat or shrink tumors when given before cancer surgery. The goal of studying this approach is to improve treatment of this cancer and decrease the chance that cancer relapses after surgery. The use of adagrasib in this research study is investigational. The word “investigational” means that adagrasib is not approved for marketing, or to treat lung cancer, by the Food and Drug Administration (FDA). Nivolumab is approved by the Food and Drug Administration (FDA) for the treatment of lung cancer. However, combining nivolumab with adagrasib is not FDA approved and is investigational in this study. There are two study groups: Group A and Group B. Group A will receive adagrasib alone. Group B will receive adagrasib and nivolumab.

Are you Eligible? (Inclusion Criteria)

• Must be 18 years old or older - Must have non-small cell lung cancer confirmed by tissue study - Must not have had major surgery within 4 weeks prior to first dose of study treatment - Women must not be pregnant or nursing