NCT07160686RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1456 (estimated)
- First submitted
- 29 Jul 2025
- Start date
- 28 Apr 2026
- Primary completion date
- 30 Oct 2029
- Lead sponsor
- University of Birmingham
- Diseases
- Lung cancer, Childhood cancers
- NCT number
- NCT07160686
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1456
- From 28 Apr 2026 to the primary completion date, 30 Oct 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The usage of medications contraindicated with apixaban
- Receiving SACT for potentially resectable / resectable lung cancer as part of neo-adjuvant or adjuvant treatment
Other illness
- 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
- Continuous anticoagulation (e.g., unfractionated heparin, low molecular weight heparins, heparin derivatives and oral anticoagulants) for other medical conditions
Lab values
- 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)
Other
- Weight \< 40kg
- Estimated life expectancy \< 6 months
- 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
- SACT with significant potential DDI with apixaban (section 7.2.3)
Who the study is looking for
- 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)
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dorset County Hospital Coordinator of this site? Confirm its status | Dorchester | United Kingdom | Recruiting |
| Royal Devon and Exeter Hospital Coordinator of this site? Confirm its status | Exeter | United Kingdom | Recruiting |
| James Paget Hospital Coordinator of this site? Confirm its status | Gorleston-on-Sea | United Kingdom | Recruiting |
| Withybush General Hospital Coordinator of this site? Confirm its status | Haverfordwest | United Kingdom | Recruiting |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Queens Hospital Romford Coordinator of this site? Confirm its status | Romford | United Kingdom | Recruiting |
| Royal Shrewsbury Hospital Coordinator of this site? Confirm its status | Shrewsbury | United Kingdom | Recruiting |
| Kings Mill Hospital Coordinator of this site? Confirm its status | Sutton in Ashfield | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.