Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Birmingham

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Apixaban
  • Placebo

Treatment groups

1,456 Participants
are divided into 2 treatment groups

Sponsors and collaborators