SPARK Study

SPARK – A Study for Patients with KRAS Drug Resistance

NCT05272423

Dr. Mark Awad
Dana-Farber Institute

This research study is evaluating new mutations that develop after treatment with targeted therapies in patients with lung cancer that is positive for a marker called “KRAS”.

KRAS-positive lung cancer is a subtype of lung cancer which carries a change in a gene called KRAS. There are now drugs for patients with KRAS-positive lung cancer that slow cancer growth. However, after some time, KRAS-positive lung cancers evolve ways to avoid the therapies by developing new mutations so the drugs lose their effectiveness. A deeper understanding of the biology behind resistance to KRAS inhibitors has the potential to inform future lines of therapy and novel combinations for individuals with KRAS driven lung cancer.

We are now able to detect the presence of mutations or changes in the genetic structure in lung cancer by analyzing a patient’s blood for bits of material shed by tumor. This approach is often called a liquid biopsy. Obtaining liquid biopsies on patients with KRAS-positive lung cancers at resistance to therapy may help us better understand the different mutations that develop and guide therapy decisions.

In this research study, we will collect a blood specimen and submit it for liquid biopsy analysis at a commercial diagnostic company. Specifically, we will look for genetic changes in the KRAS gene that could help understand why a cancer has developed drug resistance. You will not have to have a tissue biopsy to participate in this study. You do not have to visit our facility to participate. All study procedures will be performed remotely.

You are invited to take part in this research study, because you have KRAS-positive lung cancer and have been on a KRAS targeted treatment such as sotorasib or adagrasib.

Click on topic below for more information.

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 Foundation Medicine. This company specializes in analyzing tumor material found in blood by examining the blood plasma, the liquid component of blood that remains after cells, platelets, and other components are removed. DNA is extracted from the blood plasma and sequenced to look for genetic changes in genes that may be important to lung cancer. Specifically, we will look for genetic changes in the KRAS 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 the study team to learn about the study activities. After you speak with the study 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 KRAS targeted therapy (such as sotorasib or adagrasib) to determine your eligibility for this study.

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

Study Intake Form – The form reflects the inclusion/exclusion criteria and 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 to a medical provider or local laboratory of your choice for collection of the blood specimen or request the study team to send a phlebotomist directly to your home for this blood collection.

All blood collected (approximately 4 tubes of 8-10ml each) will be returned to the study team at Dana-Farber Cancer Institute using prepaid and pre-labeled shipping materials that are provided.
Two tubes of the blood specimen tubes will then be sent to Foundation Medicine where they will be tested to look for genetic mutations in KRAS and other genes that may be important to a lung cancer. You and your doctor will receive a copy of these research-only test results.
The other two tubes of the blood will be saved for future studies to understand cancer treatment resistance. Because those analyses are exploratory you will not receive their results back.

Medical Records – We will collect copies of pathology reports from any prior tumor biopsies, imaging reports (CT scans, MRIs, X-rays, and bone scans), genomic testing reports, and medical records.

Archival Tissue Collection – On a case-by-case basis, the study team may seek archival (stored) tissue specimens to better understand novel or conflicting liquid biopsy results. You do not need a biopsy to participate in this study.

Archival Liquid Biopsy Result Collection – On a case-by-case basis, the study team may seek results of any liquid biopsy performed prior to the enrollment in this study.

Follow Up for 3 Years – We would like to track your medical condition for a minimum of 8 months and up to three years. We would like to do this by contacting you approximately every week for 4 weeks and then once every 3 months for up to 3 years. In addition, you can stop participating in the research study at any time. 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 KRAS-positive lung cancer living anywhere in the US (including Alaska, Hawaii and Puerto Rico) can participate in this study, if eligible.

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.
The study team will review the Contact Form and, if you appear to meet the study requirements, you will be provided access to the Intake and Consent forms.

Contact Form

SPARK Study (ALCMI-016)

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The following questions are optional, but can help us to assess your eligibility.

Do you have a diagnosis of KRAS positive cancer?

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What treatment are you currently on?

Within the past 30 days, has your doctor informed you that your cancer is progressing on therapy?

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