Phase I Study of Carfilzomib and Sotorasib for Treating KRAS G12C Mutated Advanced or Metastatic Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety, side effects, and best dose of combining carfilzomib with sotorasib in patients who have advanced or metastatic non-small cell lung cancer NSCLC with a KRAS G12C mutation. This phase I study focuses on patients whose cancer has progressed after prior KRAS inhibitor therapy. The goal is to find a safe dose and understand how well this combination may work in treating this specific lung cancer. Participants receive carfilzomib through an intravenous IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle, while sotorasib is taken orally once daily on days 1 through 28. Treatment cycles continue unless the disease worsens or side effects become unacceptable. Patients undergo echocardiography ECHO at screening and have CT or MRI scans plus blood samples collected during the study. Optional biopsies may also be performed. Throughout the study, patients are monitored for side effects and tumor responses using scans and blood tests. Researchers measure dose limiting toxicities and treatment-related severe side effects during the first cycle and up to 30 days after treatment ends. They also track how the cancer responds, progression-free survival, and overall survival. After treatment, patients have a follow-up visit 30 days later. The study is conducted under careful medical supervision by the City of Hope Medical Center.

Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer