What Will I Be Asked To Do?

While you are in the study, you will be asked to attend study visits which will allow the study team to collect the information they need for the study, and more importantly, see how you are doing and monitor your health status. During these visits, the study team will:

  • Discuss your past and current health and any medications you are taking and have taken in the recent past
  • Ask how you are feeling and about any changes to your health since your last visit
  • Conduct medical exams including measuring height, weight, and vital signs
  • Perform other examinations, which may include electrocardiogram (often called ECG), computed tomography (CT) and magnetic resonance imaging (MRI) scans, ECOG performance status evaluation (ability to perform self-care activities) and biopsies
  • Test your blood and urine
  • Give you your study medication
  • Ask if you are taking any new medications and complete study questionnaires

Your participation is voluntary, and you are free to withdraw at any time, without giving any reason and without your medical care or legal rights being affected.

Study Visit Schedule

If you qualify for the study, your study team will tell you which treatment group (either the experimental IDE196+Crizotinib or Standard of Care) you will participate in during the treatment period.

For both the groups, there will be 3 periods in the study: the screening period, the treatment period, and the follow-up period.

The figure below shows what will happen during each period.

Screening

The study doctor will complete tests to determine if you are eligible for the study.

Up to 28 days

Treatment

IDE196 plus crizotinib Treatment Group

Standard-of-Care Treatment Group

You will take your study medication 2 times per day by mouth, at home.

Each cycle of study medication is approximately 21 days.

The standard-of-care treatment will be given to you as intravenous infusions at the clinic/hospital every 3 weeks.

Each cycle of study medication is 21 days.

12-24 months

Follow-up

  • Once you complete all of your study drug treatment, there will be an End of Study Treatment visit, which then will be followed by a Safety Follow-up visit 28 days after the last dose.
  • In addition, you will be contacted by your study team by phone, text or e-mail every 3 months after your last study visit to check how you are doing and to collect information on any new cancer treatments you have started.

Up to approximately 24 months

Why Should I Join the IDE196-002 Study

If you qualify and agree to participate in IDE196-002, you will help doctors and researchers gather important information on the study drugs, understand your tumor type, and to further the study of cancer. Your participation may help patients get better care in the future. If you choose to participate in the study, you will receive the study medication and study-related medical care at no cost.