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About Clinical Research

Clinical research studies are done to test investigational medications for diseases and conditions. Studies help determine if investigational medications are safe to use and work to improve the health of people. Before any medication can be approved and made available to the general public, it has to go through several phases of clinical research.

Why do people participate in studies?

People participate in clinical research studies for a variety of reasons. Some volunteers may participate in studies because they want to learn more about their disease. Others volunteer to participate because they want to help researchers learn more about a disease so that it may help them and others in the future.

Are clinical studies safe?

Clinical research studies follow a specific set of standards and are closely regulated to ensure the safety of all participants. Safety precautions are put in place to protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is designed to make sure all study procedures are conducted correctly and safely.

What if I have questions during the study?

You can ask questions of the study staff at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participants. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study staff at any time.

Can I leave the study once it has started?

Study participation is completely voluntary, and you can end your participation at any time, for any reason. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit, but there will be no negative impact on the care you receive.

Can I see other doctors during the study?

You can visit any doctor to meet your needs during the study. Please let the study doctor know that you will be seeing another doctor and if any medication is prescribed during the visit.

About the Study

The Xalt2 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 able to join the Xalt2 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 Xalt2 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 Xalt2 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 Xalt2 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

About ALK Positive NCSLC

Non-small cell lung cancer (NSCLC) is one of two types of lung cancer (the other is small cell lung cancer). Most lung cancers are NSCLC. Of the people who have NSCLC, only 3 percent to 5 percent of them have tumors that test positive for a gene alteration called anaplastic lymphoma kinase (ALK), which affects the development and growth of tumors. A gene alteration is a change in the gene.

Some people are more likely to have the ALK gene alteration than other people. Younger people, people who have never smoked, women, and people who are of East Asian decent are more likely to be diagnosed with NSCLC that is ALK positive.

The Xalt2 study is for people with NSCLC whose tumor tests positive for ALK. ALK is a genetic alteration that has rearranged genes in the body to make it easier for tumors to develop and grow. The ALK alteration is not an inherited gene like some other genes associated with cancer.

Medications called tyrosine kinase inhibitors (TKIs) have been shown to delay tumor growth or even reverse the size of tumors, including tumors that are ALK positive. There are several TKIs available as treatment for NSCLC that is ALK positive. However, although many people respond well to treatment with currently available TKIs, most people eventually become resistant to the treatment, meaning that it no longer works well for them.

The medication being evaluated in the Xalt2 study is a TKI called X-396. X-396 has the potential to block the effects of the ALK gene. The Xalt2 study is evaluating whether X-396 is safe and whether tumors of people with ALK positive NSCLC respond to the medication.