SPACEWALK Study

SPACEWALK – A Study for Patients with ALK Drug Resistance

geoffrey oxnard

Geoffrey R. Oxnard, MD
Dana-Farber Cancer Institute

ALK-positive lung cancer is a subtype of lung cancer which carries a genetic change in a gene called ALK (anaplastic lymphoma kinase). About 5% of lung cancers are ALK-positive. These ALK-positive lung cancers carry a genetic change which results in an abnormal ALK protein that tells the cancer to grow.

There are now many drugs that target and block the abnormal ALK protein and inhibit the growth of the cancer. These targeted therapies have provided great benefit to people with ALK-positive lung cancer. However, after some time, just as bacteria evolve resistance to antibiotics, ALK-positive lung cancers evolve ways to evade the therapies so the drugs lose their effectiveness. Recently, it has been found that ALK-positive lung cancer cells can evade the drugs by developing new mutations in the ALK gene. These new mutations can potentially be treated with a different drug targeting these specific ALK mutations.

We are now able to detect the presence of genetic mutations in lung cancer by analyzing a patient’s blood for bits of material shed by tumor. This approach is often called a liquid biopsy. Recently, researchers have shown that looking at tumor molecules in blood can provide doctors with some of the same information that tissue biopsies provide. For example, liquid biopsies can be used to detect gene mutations that cause drug resistance.

This research study is for lung cancer patients with ALK-positive lung cancer who had been on a newer ALK targeted treatment (such as ceritinib, alectinib, brigatinib, or lorlatinib) to determine whether they have developed ALK resistance mutations.

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Study Purpose
In this research study, we will collect a blood specimen and submit it for liquid biopsy analysis at a commercial diagnostic company called Resolution Bioscience. This company specializes in analyzing tumor material found in blood. More specifically, they examine the blood plasma, the liquid component of blood that remains after cells, platelets, and other components are removed. DNA is removed from the blood plasma and sequenced to look for genetic changes in genes that may be important to a lung cancer. Specifically, we will look for genetic changes in the ALK gene that could help understand why a cancer has developed drug resistance.
What Should You Expect in This Study
The research study has certain requirements that must be met. If you do not meet the requirements, you will not be able to participate in this research study.

The process begins when you speak with a member of our study team to learn about the study activities. After you speak with our team, you will be provided with an informed consent form to review. The consent form explains this research study in detail. You will also provide us with a copy of your molecular analysis report and medical record indicating that your cancer has developed a resistance to ALK targeted therapy (such as ceritinib, alectinib, brigatinib or lorlatinib) to determine your eligibility for this study.

If you are eligible for the study, you will work with our study team to complete the following tasks:

Intake Form – The form requests your contact information, emergency contact information, and the treating physician’s contact information. This will allow the study team to keep your treating physician aware of the results of the liquid biopsy testing. We will send your treating physician an introductory letter and will then send them the results of the liquid biopsy testing when available.
Medical Release Form – This document gives the study team permission to obtain and review your medical records pertaining to any personal history you have of cancer. This will allow us to further confirm your eligibility for this study.
Blood Specimen – You will provide a small amount of blood, (approximately 3 tablespoons or 40 mL). We will ship a blood collection kit to your home. You can bring this kit a medical provider of your choice for collection of the blood specimen.

  • You will ship the blood specimen (in a pre-paid shipping package) to Resolution Bioscience where two tubes will be tested to look for genetic mutations in ALK and other genes that may be important to lung cancer. You and your doctor will receive a copy of the test results.
  • The other two tubes of the blood will be saved for future studies to understand ALK treatment resistance. Because those analyses are exploratory you will not receive their results back.

Follow Up for 2 Years – We would like to track your medical condition for up to two years. We would like to do this by contacting you every week for the first 4 weeks and once every 3 months thereafter to see how you are doing or by reviewing your medical records. Keeping in touch with you and checking your condition helps us look at the long-term effects of the research study.

How To Participate
Individuals with ALK-positive lung cancer living anywhere in the US (including Alaska, Hawaii and Puerto Rico) can participate in this study, if eligible.

  1. The first step is to complete the Contact Form. A member of our study team will contact you to schedule a time to review the eligibility requirements and study activities. Or you can call the SPACEWALK study team at 844-44-SPACE (844-447-7223).
  2. The study team will review the pre-screening questionnaire and, if you meet the pre-screening requirements, you will be provided access to the consent form.
Contact Form
SPACEWALK Study (ALCMI-011)
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