Clinical trial · Interventional
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
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thromboprophylaxis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apixaban | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apixaban
- description
- apixaban 2.5 mg twice a day for 6 months
- interventionNames
- Drug: Apixaban
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- apixaban matched placebo twice a day for 6 months
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- 18.3.1.1 Objectively confirmed VTE
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available