AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

K-SAB trial

The K-SAB trial is a medical study focused on advanced non-small cell lung cancer that has a particular change in a gene called KRASG12C. This type of lung cancer can be challenging to treat. Doctors are looking for better treatment options for people who have already tried at least one other treatment without success, or for those who cannot safely receive standard treatments like immunotherapy or chemotherapy. This trial is in its early stages (Phase 1), which means researchers are primarily checking the safety of the new treatment and how the body handles it. They will also look to see if it shows any promise in treating the cancer. It's an important step in finding new medicines for a complex condition.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Karolinska University Hospital

Enrolment target

Start

25 Oct 2024

Advanced KRASG12C-mutated non-small cell lung cancer subjects who previosly progressed on at least one prior line of therapy or who have contraindications for immuno/chemotherapy.

What is this study about?

The K-SAB trial is a medical research study for people with a specific type of lung cancer. This cancer is called Non-Small Cell Lung Cancer, and it has a particular change (mutation) in a gene known as KRASG12C. When cancer has this specific gene change, it can sometimes be harder to treat with standard medicines. The study is for advanced cancer, meaning it has grown or spread beyond where it started.

This trial is in its early stages, known as Phase 1. In Phase 1 studies, the main goal is to find out if a new treatment is safe for people and what the right dose might be. Scientists also start to look for early signs of whether the treatment is working. It's an essential first step before a new medicine can be tested in more people.

The overall aim of the K-SAB trial is to discover new and more effective ways to help people living with this specific type of lung cancer, especially when other treatments haven't worked or can't be used.

Key takeaways

The K-SAB trial is for a specific type of advanced lung cancer (KRASG12C-mutated non-small cell lung cancer).
It's for people whose previous treatments haven't worked or who can't have certain other therapies.
This is an early-stage (Phase 1) study, focusing on safety and how the new treatment works in the body.
Participation involves regular clinic visits, blood tests, and medical assessments.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for the K-SAB trial, you need to be an adult, 18 years or older, with a diagnosis of advanced non-small cell lung cancer.

Your cancer must have a specific genetic change called KRASG12C. This is usually found through special tests on your cancer cells. Also, you must have already tried at least one other cancer treatment that didn't work for you, or your doctor has determined that you cannot safely receive common treatments like immunotherapy or chemotherapy due to other health reasons.

There might be other specific health requirements or conditions that would prevent someone from joining the study, but these would be discussed in detail by the study team.

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.

Are you 18 years or older?
Do you have advanced non-small cell lung cancer?
Has your cancer been tested and found to have a KRASG12C mutation?
Have you already tried at least one other treatment for your lung cancer, or have you been told you can't have immunotherapy or chemotherapy?
Are you able to attend regular clinic appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the K-SAB trial, you would be receiving a new intervention, which is an experimental treatment researchers are testing. Because it's an early-stage (Phase 1) trial, you would have regular visits to the clinic for medical check-ups, blood tests, and scans. These assessments help the doctors monitor your health, see how your body is reacting to the treatment, and determine if the treatment is having any effect on your cancer. The exact number of visits, tests, and total duration depends on how you respond to the treatment and the study's specific plan, which the study staff would explain thoroughly.

Potential risks and benefits

Taking part in a trial involving a new treatment means there's a chance the treatment might help your condition, potentially slowing down or improving your lung cancer. However, as with any new treatment, there are also potential risks, including side effects that are not yet fully known. The research team will carefully monitor you for any side effects and will explain all known risks before you decide to join. Remember, you have the right to withdraw from the trial at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
Sweden

Common questions

What does 'advanced' lung cancer mean?

Advanced lung cancer means the cancer has grown or spread beyond the original site in the lung.

What is a 'KRASG12C mutation'?

It's a specific change in one of the genes within your cancer cells. Doctors test for this to choose the best treatment.

What is a 'Phase 1' trial?

Phase 1 is the first step where a new treatment is tested in people. The main goals are to check for safety and find the right dose.

Will this trial cure my cancer?

This is a research study to find new treatments. While the aim is to help, there's no guarantee of a cure, especially in early-stage trials.

What if I've already had other treatments?

This trial is specifically for people who have already tried at least one other treatment for their lung cancer or cannot have other common treatments.