A Phase I/II Study of Ruxolitinib plus Erlotinib in Patients with Erlotinib-Resistant Lung Adenocarcinoma

Protocol
14-043
Full Title
A Phase 1/2 Trial of Ruxolitinib and Erlotinib in Patients with EGFR-mutant Lung Adenocarcinoma with Acquired Resistance to Erlotinib
Phase
I/II
Purpose

Most non-small cell lung cancers (NSCLC) with EGFR mutations treated with the standard therapy erlotinib (a drug used that blocks EGFR) eventually come back or continue to grow despite this treatment. Researchers want to find out if adding the drug ruxolitinib to erlotinib therapy might make treatment more effective.

Ruxolitinib is a pill that is approved for the treatment of myelofibrosis (scarring of the bone marrow); its use in this study is considered investigational. It works by inhibiting a protein called JAK that may be increased when tumors become resistant to erlotinib. Laboratory studies suggest that giving ruxolitinib with erlotinib helps erlotinib work better.

Ruxolitinib and erlotinib are both taken orally (by mouth).

Eligibility

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

  • Patients must have EGFR-mutant NSCLC that has come back or spread (metastasized) after initially shrinking with erlotinib therapy.
  • At least 3 weeks must pass between completion of prior chemotherapy (except erlotinib, which is allowed) and 2 weeks since completion of any radiation therapy and entry into the study.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-888-4274.

Disease(s)
Lung Cancer, Non-Small Cell: Lung Adenocarcinoma