Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment
A Phase III, Multicentre, Double Blind, Placebo-Controlled, Randomised Clinical Trial of Apixaban THROMBOprophylaxiS TO Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment
- Thromboprophylaxis
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- University of Birmingham
- Enrolment target
- 1,456
- Started
- 28 April 2026
- Main results due
- 30 October 2029
- Study sites
- 8
- Registry updated
- 28 September 2026
Can you take part?
- Aged 16 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion criteria * Age ≥ 16 years * Newly diagnosed locally advanced or metastatic primary lung cancer (histologically/ cytologically confirmed) or disease progression after complete or partial remission commencing a new course of SACT alone or as CRT * Ambulatory (receiving outpatient SACT) Exclusion criteria * Hypersensitivity to apixaban or to any of the listed SmPC excipients * Active clinically significant bleeding * Lesion or condition considered a significant risk factor for major bleeding * Hepatic disease associated with impaired synthetic function * Platelet count \< 50 x 109 /L * Elevated liver enzymes ALT/AST \> 2 x ULN or total bilirubin ≥ 1.5 x ULN * Renal failure (creatinine clearance \< 15ml/min) * Weight \< 40kg * Estimated life expectancy \< 6 months * Continuous anticoagulation (e.g., unfractionated heparin, low molecular weight heparins, heparin derivatives and oral anticoagulants) for other medical conditions * The usage of medications contraindicated with apixaban * Pregnancy * Breast feeding * Judgement by the Investigator that the participant is unsuitable to participate in the trial and the participant is unlikely to comply with trial procedures, restrictions and requirements * Inability to consent * Receiving SACT for potentially resectable / resectable lung cancer as part of neo-adjuvant or adjuvant treatment * SACT with significant potential DDI with apixaban (section 7.2.3)
What this study is about
In the sponsor’s own words, from the registry.
The aim of this trial is to find out if a tablet called apixaban can reduce blood clots in people with lung cancer having chemotherapy or similar treatments. Apixaban is a type of oral anticoagulant ("blood thinner") that makes the blood less sticky to prevent blood clots forming.
The trial is trying to find out if apixaban it can reduce blood clots in people with lung cancer.
Participants will receive the following treatment:
• Apixaban or placebo, 2.5mg taken by mouth twice a day for 6 months. This treatment will be taken in addition to any treatment that they are receiving to treat their lung cancer.
Participants will need to:
* Sign a consent form to enter the trial. * Take the trial treatment as directed by the research team * Complete a participant diary to record when they took the trial treatment * Complete the Quality of Life and Health resource use questionnaires. * Female participants of childbearing potential must use adequate contraception during the trial and for at least 2 days after trial treatment has finished.
Study sites(8)
Dorset County Hospital
Dorchester, United Kingdom
Recruiting
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Recruiting
James Paget Hospital
Gorleston-on-Sea, United Kingdom
Recruiting
Withybush General Hospital
Haverfordwest, United Kingdom
Recruiting
Queen Elizabeth Hospital
London, United Kingdom
Recruiting
Queens Hospital Romford
Romford, United Kingdom
Recruiting
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom
Recruiting
Kings Mill Hospital
Sutton in Ashfield, United Kingdom
Recruiting
Showing 8 of 8 sites. 8 of the 8 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07160686. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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