Status:
NOT_YET_RECRUITING
Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment
Lead Sponsor:
University of Birmingham
Conditions:
Thromboprophylaxis
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
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 (...
Detailed Description
Venous thromboembolism (VTE) is common in lung cancer and results in worse quality of life, increased healthcare costs, increased morbidity, and mortality. VTE is also increased in lung cancer patient...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 2 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2030
Estimated Enrollment :
1456 Patients enrolled
Trial Details
Trial ID
NCT07160686
Start Date
March 2 2026
End Date
March 30 2030
Last Update
September 8 2025
Active Locations (1)
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1
University of Birmingham
Birmingham, United Kingdom, B15 2TT