A Phase II Study of Bortezomib in Patients with KRAS-Mutant Non-Small Cell Lung Cancer

Protocol
12-222
Full Title
A Phase 2 Trial of Bortezomib in KRAS-Mutant Non-Small Cell Lung Cancer in Never Smokers or Those with KRAS G12D
Phase
II
Purpose

The purpose of this study is to evaluate the safety and effectiveness of the drug bortezomib in never-smokers with non-small cell lung cancer (NSCLC) that contains a mutation in the KRAS gene. Former or current smokers with NSCLC that contains a specific mutation called KRAS G12D may also participate.

Bortezomib is approved for treating multiple myeloma and mantle cell lymphoma, but its use in this study is considered investigational. Research suggests that certain patients with KRAS-mutant lung cancer may benefit from bortezomib therapy as well. Bortezomib works by inhibiting many proteins (known as proteasomes) that cancer cells need to survive and multiply.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be never-smokers (less then 100 cigarettes smoked in a lifetime) with KRAS-mutant NSCLC, or current/former smokers with NSCLC who have a KRAS G12D mutation.
  • Patients’ cancers must be stage IIIB or stage IV, or be inoperable.
  • At least 3 weeks must have passed since completion of prior chemotherapy or radiation therapy and entry into the study.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Gregory Riely at 646-888-4199.

Disease(s)
Lung Cancer, Non-Small Cell