A Phase II Study of CO-1686 in Patients with Previously Treated Non-Small Cell Lung Cancer Containing an EGFR T790M Mutation

Protocol
14-084
Full Title
A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral CO-1686 in Patients with Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)
Phase
I/II
Purpose

Most non-small cell lung cancers (NSCLC) treated with the standard therapy erlotinib (a drug used to treat cancers with a mutated form of the epidermal growth factor receptor, or EGFR) eventually come back or continue to grow despite this treatment. In many patients, the resistance to EGFR inhibitors like erlotinib is due to a mutation called EGFR T790M.

In this study, researchers are evaluating the safety and effectiveness of an investigational drug called CO-1686 in patients with NSCLC that contain an EGFR T790M mutation. CO-1686 targets cancer cells containing this mutation. Doctors hope it will be effective in patients whose NSCLC has stopped responding to erlotinib or other EGFR inhibitors.

CO-1686 is a pill that is taken orally (by mouth) twice a day.

Eligibility

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

  • Patients must have NSCLC that contains an EGFR T790M mutation and has continued to grow despite prior treatment with an EGFR inhibitor (such as erlotinib or similar medications).
  • There are different cohorts (groups of patients) in this study. Eligibility for each cohort is based on patients’ prior treatments.
  • 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.
  • A repeat biopsy of each patient’s tumor will be required.
  • 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