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.
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)
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
Parallel
Apixaban
Drugapixaban 2.5mg twice a day for 6 months
Placebo
Other interventionPlacebo twice a day for 6 months
18.3.1.1 Objectively confirmed VTE
Difference between a composite of objectively confirmed VTE and VTE-related death in participants with lung cancer, commencing SACT or CRT, when treated with 6 months of apixaban vs. placebo.
Objectively confirmed VTE including all cause death
Composite of: i. New proximal or distal DVT (symptomatic or incidental) of upper or lower limbs, iliac veins, inferior/superior vena cava or central venous catheter related thrombosis ii. Non-fatal PE (symptomatic or incidental) iii. Death from any cause
Bleeding outcomes
* Major bleeding * Clinically relevant bleeding: Defined as the rate of participants experiencing at least one major bleeding and/or a clinically relevant non-major bleeding (CRNMB)
Net clinical benefit
Net clinical benefit (NCB) combines the primary efficacy outcome and major bleeding or clinically relevant bleeding. NCB is defined as: \[the rate of VTE prevented by apixaban\] minus \[the rate of major or clinically relevant bleeding induced by apixaban\]. NCB= (VTE\_control-VTE\_apixaban ) - (Weighting × (Bleed\_apixaban-Bleed\_control )) VTE; the rate of objectively confirmed VTE or VTE related deaths (as defined for our primary outcome) Bleed; the rate of major bleeding or clinically relevant bleeding (as defined above). A default weighting factor of 1.0 will be used to represent an equal clinical weighting between the prevention of VTE by apixaban and the induction of major bleeding by apixaban, however supplementary analyses may be performed with a different weighting.
Proximal or distal DVT (symptomatic or incidental)
The rate of proximal or distal DVT will be collected and the Odds Ratio of apixaban vs placebo will be reported.
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