Clinical Trials | 10660: A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib Plus Trastuzumab Deruxtecan in Patients with Advanced Non-Small Cell Lung Cancer with a KRASG12C Mutation

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Advanced Non-Small Cell Lung Cancer with a KRASG12C Mutation for a research study. The purpose of this study is to test the safety of a drug called trastuzumab deruxtecan (DS-8201a) at different doses in combination with different doses of sotorasib. This study will test different doses of the drugs together to find the highest doses that can be taken safely for people. The study is designed to find dose levels where serious side effects occur in up to about 30% of participants. In this study, you will get the study drug trastuzumab deruxtecan (DS-8201a) in combination with sotorasib. The amount of the drugs you will be given will depend on when you are enrolled in the study. The first three participants will receive the study drugs at the lowest amounts. Each subsequent group of three will receive higher doses until the right dose is found. During your study treatment, you will be seen by your healthcare team in a clinic visit once every 3 weeks (21 days). You will continue treatment unless your disease gets worse, or the side effects become too severe. After you complete your study treatment, your doctor and study team will watch you for side effects and ask about other cancer treatments you are receiving through phone calls. They will check you every 3 months for up to 5 years after treatment. This means you will continue to be contacted by the research team for up to 5 years after you complete your treatment on this study. Additional information found here: https://clinicaltrials.gov/study/NCT07012031 For questions, contact: [email protected]