exalt2 Phase 2 Study

About the Study

The eXalt2 clinical research study is for adults with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC). The purpose of the study is to evaluate the safety of and see how tumors respond to an investigational medication called X-396 in patients with NSCLC whose tumors test positive for the ALK gene.

Who can participate

You may be eligible to join the eXalt2 clinical research study if you:

  • Are 18 years of age or older
  • Have been diagnosed with ALK positive NSCLC
  • Are not allergic to crizotinib or ceritinib (available as XALKORI®or ZYKADIA™)

About the investigational medication

Some genes can change and affect the way that tumors develop and grow. The investigational medication in the eXalt2 study targets tumors that test positive for anaplastic lymphoma kinase (ALK).

Previous research suggests that X-396 has the potential to block the effects of the ALK gene, which has been known to affect the development and growth of tumors. Previous research has also shown that X-396 can more strongly block the ALK gene than currently available cancer treatments.

Participants in the eXalt2 study will take X-396 by mouth once per day at the same time each day with a full glass of water. The study staff will tell you whether you should take the medication with or without food.

What will happen during the study

If you are eligible and agree to participate in the eXalt2 clinical research study, you will be required to:

  • Visit the study site as directed by the study staff
  • Undergo study-related tests and procedures at study visits including physical exams, blood and urine tests, and ECGs
  • Take the investigational medication as directed by the study doctor and staff

Clinical Sites Now Recruiting*

* Additional sites to be added in the near future

For more information on this study, “Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-Positive Non-Small Cell Lung Cancer,” please visit eXalt2 study or www.clinicaltrials.gov.