RecruitingNAINTERVENTIONAL

DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

This research is looking at a new test called the therascreen® KRAS RGQ PCR Kit. This test helps doctors find a particular change in a gene called KRAS G12C, which is sometimes found in people with bowel cancer that has spread (metastatic colorectal cancer). The main goal of this study is to see if this new test can accurately identify patients who might benefit from a new medicine called sotorasib. The study is running at the same time as a larger trial (CodeBreaK 301) for people with this type of bowel cancer. If the test works well, it could become a standard way for doctors to decide if sotorasib is a good treatment option for patients with this specific gene change. This helps ensure patients get the most suitable treatment for their cancer.

At a glance

Status

Recruiting

Phase

Sponsor

QIAGEN Gaithersburg, Inc

Enrolment target

600

Start

22 Dec 2023

Estimated completion

31 Oct 2030

Metastatic Colorectal Cancer (mCRC)

What is this study about?

This study is looking at a specific gene change, called KRAS G12C, which can be found in some people with bowel cancer that has spread to other parts of the body (this is called metastatic colorectal cancer, or mCRC). We know that some treatments work better for certain types of cancer depending on these gene changes. So, finding out if a patient has this specific change is really important for choosing the right treatment.

This research is particularly focused on a new test called the "therascreen® KRAS RGQ PCR Kit." The main aim is to see how well this test can find the KRAS G12C gene change in a patient's tumour. If the test is accurate, it could help doctors identify which patients might benefit from a new drug called sotorasib. Sotorasib is a medicine being studied for treating this specific type of bowel cancer.

This study is happening alongside a larger clinical trial called CodeBreaK 301. In that larger trial, approximately 450 patients from many different countries will be enrolled if they have the KRAS G12C mutation. By running these studies together, researchers can gather important information about both the new test and the new medicine at the same time, helping to speed up the process of getting effective treatments to patients who need them.

Key takeaways

This study is testing a new way to identify a specific gene change (KRAS G12C) in advanced bowel cancer.
Finding this gene change helps doctors understand if a new medicine, sotorasib, might be a suitable treatment option.
The study helps validate the new test kit to ensure it accurately identifies patients who might benefit.
It's running alongside a larger drug trial for a new cancer treatment.
Your tumour tissue would be tested to see if you have the KRAS G12C change.

Who may be eligible?

To be considered for this study, you would need to have bowel cancer that has spread (metastatic colorectal cancer). Your doctors would then need to check a sample of your tumour tissue to see if it has a specific change in a gene called KRAS G12C.

Only people who agree to have their tumour tested for this specific KRAS G12C gene change would be considered for the main treatment study if the test results show you have it.

There are no other specific rules about who can or cannot be part of the test study itself. However, if you are found to have the KRAS G12C gene change, you would then need to meet the other requirements for the larger CodeBreaK 301 treatment trial, which your doctor can explain to you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have bowel cancer (colorectal cancer) that has spread (metastatic)?
Am I willing to have my tumour tissue tested for a specific gene change (KRAS G12C)?
Am I 18 years old or older?
Am I willing to consider participating in further treatment if my tumour shows the specific gene change?

Answer every question to see your result.

What does participation involve?

If you are considering taking part, your journey would typically start with your medical team collecting a small sample of your tumour tissue. This sample would then be tested using the new "therascreen® KRAS RGQ PCR Kit" to see if you have the specific KRAS G12C gene change. This test is crucial as it helps determine if you might be suitable for the main treatment trial.

Taking part in the initial screening for the gene change doesn't automatically mean you'll be in the larger treatment study. If your tumour tests positive for the KRAS G12C gene and you meet all the other conditions for the main study, your doctor will discuss the next steps with you. The bigger study (CodeBreaK 301) involves receiving treatment, likely including the new medicine sotorasib, and would involve regular hospital visits for assessments, medication administration, and monitoring your health. The total duration of participation in the treatment trial, including follow-up, would be fully explained by your care team.

Potential risks and benefits

The main benefit of this study could be that if the new test works well, it will help doctors in the future to more accurately identify patients with metastatic colorectal cancer who are most likely to benefit from treatments like sotorasib. For those who participate and are eligible for the main drug trial, they might have access to a new treatment option. As with all medical procedures, obtaining a tumour sample has minor risks, such as discomfort or bleeding, which your doctor will discuss with you. While the test itself is low risk, any treatment within the larger trial would have its own potential benefits and side effects. Remember, you have the right to ask questions and to withdraw from *any* part of the study at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

QIAGEN Gaithersburg, Inc
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is metastatic colorectal cancer?

It's bowel cancer that has spread from where it started to other parts of your body.

What is the KRAS G12C gene change?

It's a specific change in one of your genes (KRAS) that can sometimes be found in cancer cells and can affect how the cancer grows.

What is sotorasib?

Sotorasib is a new medicine being studied to treat certain cancers, including advanced bowel cancer with the KRAS G12C gene change.

Will I get this new treatment if I join the study?

This study is mainly about testing a new way to find the gene change. If you have the gene change and meet other rules, you might be invited to join the main drug trial where you could receive the treatment.

How long will this study last for me?

The time it takes to test your tumour sample for the gene change is relatively short. If you then join the main drug trial, your participation would last longer, and your doctor will tell you all the details.

How to find out more

Sarah Johnson, Dr.

sarah.johnson@qiagen.com 0044 07825866041 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.