A Phase IB/II Study of IPI-504 plus Everolimus in Patients with KRAS-Mutant Non-Small Cell Lung Cancer

Protocol
11-114
Full Title
A Phase 1b/2 Study of IPI-504 in Combination with Everolimus in Patients with KRAS Mutant NSCLC
Phase
I/II
Purpose

IPI-504 is an investigational drug that targets the protein Hsp90, which is important for cancer growth. Everolimus is a drug approved for kidney cancer, but its use for treating lung cancer is considered investigational. Everolimus inhibits another protein which fuels cancer growth, called mTOR.

In this study, researchers want to find the highest safe dose of IPI-504 and everolimus that can be given together in patients with non-small cell lung cancer (NSCLC) whose tumors have a mutation in the KRAS (phase IB portion of the study), and to see if this drug combination is effective for fighting this cancer (phase II portion). Laboratory studies have found that IPI-504 plus everolimus causes cancer cells to die and tumors to shrink.

Investigators also want to know what distinguishes patients who respond to treatment from those who do not. To determine this, they will look at patients’ genes in tumor and blood samples and compare them between responders and non-responders.

Eligibility

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

  • Patients must have stage IIIB or IV NSCLC with a KRAS mutation.
  • Patients’ disease must have persisted despite at least one prior regimen of chemotherapy with a platinum-containing drug.
  • Patients may not have had more than three prior chemotherapy regimens.
  • Patients should recover from the side effects of prior therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or 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
Lung Cancer, Non-Small Cell
Lung Cancer, Non-Small Cell: Lung Adenocarcinoma
Locations
Related Diseases