AuthorisedTherapeutic exploratory (Phase II)Interventional

A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer

This study, called a Phase II trial, is testing a new medicine called Tarlatamab for people with small cell lung cancer that has spread to the brain. Patients in this study have active brain tumours but are not yet experiencing symptoms from them. The main goal is to find out how effective Tarlatamab is at shrinking these brain tumours and how long it can keep the cancer under control. Researchers will use regular brain scans (MRI) to measure changes in the tumours. They will also look at how the treatment affects cancer in other parts of the body, overall survival, and any side effects. This research helps us understand if Tarlatamab could be a helpful new option for this type of cancer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Academisch Ziekenhuis Maastricht

Enrolment target

Start

15 Apr 2026

patients with asymptomatic active brain metastases from small cell lung cancer

What is this study about?

This study is about testing a new medicine called Tarlatamab for people who have small cell lung cancer that has spread to their brain. This spread is often called brain metastases. The study is specifically looking at people whose brain tumours are active but not yet causing noticeable symptoms. The main purpose of the study is to see how well Tarlatamab works to shrink or stop the growth of these brain tumours. This is considered a "Phase II" study, which means it's one of the earlier steps in testing new treatments to see if they are safe and effective enough to move on to larger studies.

To understand if Tarlatamab is working, doctors will use regular brain scans, called MRI scans. They will take a scan after six weeks of treatment and then every six weeks after that. They will be looking to see if the brain tumours shrink in size or stop growing. They will also check if the treatment helps keep the cancer under control in other parts of the body using different scans. The study will also track how long people live, and importantly, look carefully at any side effects people might experience.

This research is important because small cell lung cancer that spreads to the brain can be very difficult to treat. By studying new medicines like Tarlatamab, doctors hope to find better ways to help patients and improve their quality of life. The information gathered from this study will help decide if Tarlatamab could become a standard treatment option in the future.

Key takeaways

This study is for small cell lung cancer that has spread to the brain, but is not causing symptoms.
It's testing a new medicine called Tarlatamab.
The main goal is to see how well Tarlatamab shrinks brain tumours and controls the cancer.
Regular brain scans (MRI) will be used to check tumour changes.
The study will also look at overall survival and side effects.
Both men and women aged 18 and over can be considered.

Who may be eligible?

To be considered for this study, you would need to meet certain requirements. The study is open to both men and women, and you must be at least 18 years old. There isn't an upper age limit mentioned.

A key requirement is that you have small cell lung cancer that has spread to your brain. Importantly, even though the cancer has spread to your brain, you should not be experiencing any symptoms from these brain tumours. The study is particularly looking for patients where the brain tumours are active.

There will be other medical checks and details your doctor will review to make sure this study is safe and appropriate for you. They will guide you through all the specific criteria to see if you qualify.

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.

I am at least 18 years old.
I have been diagnosed with small cell lung cancer.
My cancer has spread to my brain.
I do not currently have symptoms from the cancer in my brain.
My brain tumours are considered 'active' by my doctor.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, Tarlatamab. You would have regular appointments, where doctors would closely monitor your health and the effects of the treatment. These appointments would include physical examinations and checks for any side effects.

To see how the treatment is working, you would have regular MRI scans of your brain. These scans would typically happen after six weeks of treatment and then every six weeks afterwards. You would also have other scans, like CT scans of your chest and upper belly, to check cancer in other parts of your body. The study would continue for as long as the treatment is helping you and you are not having severe side effects. Your participation would involve these regular check-ups and scans to track your progress and safety.

Potential risks and benefits

Taking part in a clinical trial like this can offer potential benefits, such as access to a new treatment (Tarlatamab) that is not yet widely available. This treatment might help shrink your brain tumours or slow their growth. However, there are also potential risks, as Tarlatamab is being studied and its full effects, including all possible side effects, are not yet completely known. You might experience side effects, some of which could be serious. It's important to remember that you would have the right to withdraw from the study 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.

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Unverified
Netherlands

Common questions

What is small cell lung cancer?

Small cell lung cancer is a type of lung cancer that tends to grow and spread quite quickly. It often starts in the breathing tubes (bronchi) in the centre of the chest.

What are brain metastases?

Brain metastases mean that cancer cells from another part of the body, in this case, the lung, have travelled to the brain and started to grow there, forming new tumours.

What does 'asymptomatic' mean in this study?

Asymptomatic means that even though you have cancer in your brain, you are not currently experiencing any noticeable symptoms or problems because of these brain tumours.

What is Tarlatamab?

Tarlatamab is the name of the new medicine being tested in this study. It's a type of treatment that aims to fight cancer cells.

What is a 'Phase II' study?

A Phase II study is a stage of clinical research where doctors give a new treatment to a larger group of people to see if it is effective and to further evaluate its safety. It comes after early safety tests.