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

NCT07160686 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: RG_25-043NIHR165646
• Study Type: interventional
• Target: 1,456
• Locations: 1 country
• Sites: 1

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 ("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

Thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (12)

• Objectively confirmed VTE including all cause death

  6 months

• Bleeding outcomes

  6 months

• Net clinical benefit

  6 months

• Proximal or distal DVT (symptomatic or incidental)

  6 months

• Other rates of thrombosis

  6 months

Study Arms (2)

Apixaban

EXPERIMENTAL

apixaban 2.5 mg twice a day for 6 months

Drug: Apixaban

Placebo

PLACEBO COMPARATOR

apixaban matched placebo twice a day for 6 months

Other: Placebo

Interventions

Apixaban DRUG

apixaban 2.5mg twice a day for 6 months

Also known as: eliquis

Apixaban

Placebo OTHER

Placebo twice a day for 6 months

Placebo

Eligibility Criteria

• Age: 16 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Birmingham: lead

Study Sites (1)

University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

MeSH Terms

Interventions

apixaban

Study Officials

• Michael Newnham, MBChB, MSc, MRCP, PhD

  University of Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Pope, PhD

CONTACT

+44 4146372; THROMBO-STOP@trials.bham.ac.uk

Sophia Magwaro, BSc

CONTACT

THROMBO-STOP@trials.bham.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor's clinical trial management team other than the trial statisticians
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: September 8, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): March 30, 2030
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting information will be available within 12 months of the primary publication.
• Access Criteria: Data anonymised in compliance with the Information Commissioners Office requirements, using a procedure based on guidelines from the Medical Research Council (MRC) Methodology Hubs and Information Commissioners Office, will be available for sharing with researchers outside of the trials team within 12 months of the primary publication.

Locations

GB (1)