Not yet recruitingPHASE3INTERVENTIONAL

Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment

This research wants to see if a medicine called apixaban can help prevent blood clots in people with lung cancer who are receiving chemotherapy or similar treatments. Blood clots can be a serious health issue for people with lung cancer, and treatments can sometimes increase this risk. Apixaban is a type of 'blood thinner' that works by making your blood less likely to form clots. Currently, there isn't a standard treatment to prevent clots for these patients. This study will compare apixaban to a dummy pill (placebo) to find out if it's an effective and safe way to reduce this risk. Participants will take the study medicine or dummy pill for six months alongside their regular cancer treatment.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

University of Birmingham

Enrolment target

1,456

Start

02 Mar 2026

Estimated completion

30 Mar 2030

Thromboprophylaxis

What is this study about?

This study, called THROMBO-STOP, is looking into a common but serious problem for people with lung cancer: blood clots. Having lung cancer, especially while receiving treatments like chemotherapy, can increase the risk of these clots forming in the veins. These clots can make people feel unwell, sometimes very seriously, and can affect their quality of life.

Currently, there isn't a standard treatment given to all lung cancer patients to prevent these clots, especially for those who are coming to the hospital for treatment but not staying overnight. While some injectable medicines can help, they can be inconvenient. This study is testing if a tablet called apixaban could be a good, easier-to-take option.

Apixaban is already used to prevent blood clots in other situations and has a good safety record. This study aims to gather clear evidence on whether it can safely and effectively reduce the risk of blood clots for people with lung cancer who are having their usual cancer treatments. The goal is to see if taking apixaban could improve the health and well-being of these patients.

Key takeaways

Tests if apixaban (a 'blood thinner') can stop blood clots in lung cancer patients.
Participants take apixaban or a dummy pill for 6 months alongside regular cancer treatment.
Aims to improve outcomes for people with lung cancer receiving chemotherapy.
Risks include potential bleeding; benefits include reduced clot risk.
Your decision to join is voluntary and won't affect your usual care.

Who may be eligible?

To join this study, you generally need to be at least 16 years old and have a new diagnosis of lung cancer that has spread locally or further, or your cancer has returned after treatment. You must be receiving chemotherapy or similar treatments for your lung cancer as an outpatient (meaning you go home after your treatment).

There are also some reasons why you might not be able to join. For example, if you have certain existing bleeding problems, or a condition that significantly increases your risk of major bleeding. You also couldn't join if you have very low blood cell counts (platelets) or severe kidney or liver problems. If you are already taking other 'blood thinning' medicines for a different condition, or if you are pregnant or breastfeeding, you wouldn't be able to take part.

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 16 years old or older?
Do you have a new diagnosis of lung cancer or are you restarting treatment for it?
Are you receiving chemotherapy or similar treatments as an outpatient?
Do you currently have any severe bleeding problems or conditions that significantly increase bleeding risk?
Are you pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first need to read and sign a consent form, which explains everything in detail. You would then be given either the apixaban tablet or a dummy pill (placebo) to take by mouth twice a day for six months. You would take this alongside your normal lung cancer treatment.

During your time in the study, you would need to keep a simple diary to note down when you took your study medicine. You would also be asked to complete some questionnaires about your quality of life and how you use health services. If you are a woman who could become pregnant, you would need to use effective contraception during the study and for a short time afterwards. The total length of your involvement in the study will be for six months of taking the treatment, plus some follow-up.

Potential risks and benefits

Taking part in this study may offer some benefits, such as potentially reducing your risk of developing serious blood clots. Even if you receive the dummy pill, your health will be carefully monitored. However, there are also potential risks; for example, apixaban, as a 'blood thinner', could increase the risk of bleeding. The study team will monitor you closely for any side effects. You are free 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.

University of Birmingham
Verified postcode
Birmingham, United Kingdom

Common questions

What is Apixaban?

Apixaban is a medicine known as a 'blood thinner'. It helps to make your blood less sticky, which can prevent harmful blood clots from forming.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers see if the real medicine is truly making a difference.

Why is this study important?

Blood clots can be a serious problem for people with lung cancer, especially during treatment. This study hopes to find a safe and easy way to prevent these clots, which could improve patient health.

Will I know if I'm taking Apixaban or the placebo?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you're taking apixaban or the placebo. This helps ensure the study results are fair and unbiased.

How long will I be in the study?

You would take the study medicine or placebo for six months. There will also be some follow-up appointments after this time.

How to find out more

Ann Pope, PhD

thrombo-stop@trials.bham.ac.uk +44 4146372 Official trial record

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