Can apixaban prevent blood clots in ambulatory lung cancer patients on chemotherapy?
Official title: 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
Run by University of Birmingham · NCT07160686 · Data updated 2026-11-12
This trial tests whether taking apixaban can reduce blood clots in people with lung cancer who are receiving chemotherapy, compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 1456 (estimated) |
| Sponsor | University of Birmingham Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Dorchester and 7 other locations) |
| Status | Recruiting |
| Started | April 28, 2026 |
| Main results expected | October 30, 2029 |
| Study ends | March 30, 2030 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07160686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ambulatory adults and adolescents aged 16 and older with newly diagnosed locally advanced or metastatic lung cancer (or progression after prior remission) starting a new systemic anticancer treatment.
✕Probably not a fit
Patients at high risk of bleeding or with exclusion criteria (e.g., active significant bleeding, severe hepatic impairment, low platelets, very low body weight) may not benefit and could face safety concerns.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Thrombosis is common in lung cancer patients undergoing systemic anticancer therapy. This multicenter, double-blind, placebo-controlled Phase 3 trial compares apixaban 2.5 mg twice daily for 6 months to placebo in ambulatory patients with newly diagnosed locally advanced/metastatic lung cancer or progression after remission starting a new course of treatment. The study aims to detect a reduction in venous thromboembolism from 8.6% to 4% with 90% power, enrolling 1,456 participants, with additional process evaluation, acceptability, and economic analyses. Participants will provide consent, adhere to the dosing, complete diaries and QoL questionnaires, and meet contraception requirements if applicable. Safety considerations include bleeding risk and standard exclusion criteria related to bleeding, liver/kidney function, and body weight.
Why it matters
Potential benefit: If successful, patients could experience fewer blood clots and potentially improved quality of life and treatment safety during cancer therapy.
How similar studies have gone: DOACs have shown promise in cancer-associated thrombosis, but the role of apixaban for thromboprophylaxis in ambulatory lung cancer patients on chemotherapy is less established and remains an area of active investigation.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
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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
Show 2 more locations
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Royal Shrewsbury Hospital
Shrewsbury, United Kingdom Recruiting -
Kings Mill Hospital
Sutton in Ashfield, United Kingdom Recruiting
Study contacts
- Principal investigator: Michael Newnham, MBChB, MSc, MRCP, PhD — University of Birmingham
- Study coordinator: Ann Pope, PhD
- Email: THROMBO-STOP@trials.bham.ac.uk
- Phone: +44 4146372
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing rivaroxaban and low-molecular weight heparin for preventing blood clots in patients with lower limb trauma
This study is testing if a new blood thinner called rivaroxaban can prevent blood clots better than a standard treatment in patients with leg injuries who are at high risk for clots.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.