A Phase I/II Study of the ALK Inhibitor CH5424802 in Patients with ALK-Rearranged Non-Small Cell Lung Cancer

Protocol
12-113
Full Title
A Phase I/II Study of the ALK Inhibitor CH5424802/RO5424802 in Patients with ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated with Crizotinib
Phase
I/II
Purpose

Crizotinib is a drug that is approved for the treatment of non-small cell lung cancers (NSCLC) that contain an alteration in the ALK gene (a fusion of two genes that fuels cancer growth). In many patients, the response to crizotinib does not last, and the cancer begins to grow (on average, after less than a year on treatment).

The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called CH5424802, which targets the same ALK gene mutation that causes NSCLC, in patients with locally advanced or metastatic NSCLC that has continued to grow despite treatment with crizotinib. CH5424802 is a pill that is 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 locally advanced or metastatic NSCLC with a fusion of the EML4 and ALK genes.
  • Patients’ tumors must have continued to grow despite treatment with crizotinib.
  • At least 2 weeks must have passed since completion of prior chemotherapy or radiation therapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • 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, Non-Small Cell: Lung Adenocarcinoma
Locations