ThromboprophylaxisPhase 3THROMBO-STOPNCT07160686
Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment
A Phase 3 study testing Apixaban in people with Thromboprophylaxis, run by University of Birmingham at 8 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Thromboprophylaxis
- What is being tested?
- Apixaban
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,456 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 28 Apr 2026to 30 Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sophia Magwaro, BSc contact
8 sites in 1 country
United Kingdom8 sites, 8 recruiting
- Recruiting
Dorset County Hospital
Dorchester, DT1 2JY
Amelie Harle, Dr
- Recruiting
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
Elizabeth Toy, Dr
- Recruiting
James Paget Hospital
Gorleston-on-Sea, NR31 6LA
May Han, Dr
- Recruiting
Withybush General Hospital
Haverfordwest, SA61 2PZ
Alison Brewster, Dr
- Recruiting
Queen Elizabeth Hospital
London, SE18 4QH
Daniel Hughes, Dr
- Recruiting
Queens Hospital Romford
Romford, RM7 0AG
Kathryn Tarver, Dr
- Recruiting
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
Anirban Chatterjee, Dr
- Recruiting
Kings Mill Hospital
Sutton in Ashfield, NG17 4JL
Ananth Sivanandan, Dr
About this study
Official title: 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
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.
Read more
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.
Read the 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 patients undergoing systemic anticancer therapy (SACT). VTE can be reduced using anticoagulation as thromboprophylaxis, but this is not the current standard of care for outpatients having SACT. The subcutaneous anticoagulant low molecular weight heparin can reduce VTE in lung cancer but can be inconvenient to take. Apixaban is a type of direct oral anticoagulant (DOAC) taken in tablet form and not requiring regular blood monitoring, which have a good safety profile and are licensed for other medical conditions. Whilst anticoagulants have been used for thromboprophylaxis in patients with cancer, the role of DOACs in ambulatory lung cancer patients is unanswered by the existing literature.
THROMBO-STOP is a multicentre, double blind, placebo-controlled, parallel group, two arm, phase 3 randomised clinical trial testing the efficacy of Apixaban to reduce VTE in ambulatory lung cancer patients undergoing SACT. There will be a process evaluation, acceptability study and economic evaluation. For this superiority trial, 1456 patients (728 per group) are required to have a 90% power of detecting, as significant with an alpha of 0.05 (two-sided), a decrease in the rate of VTE from 8.6% in the control group (placebo) to 4% in the intervention group (apixaban), assuming a 20% drop-out rate. The planned recruitment of 1456 patients would involve 34 sites.
THROMBO-STOP patients will be recruited over a 36-month period which includes a 12-month internal pilot among a projected 40% of sites.
Data from these elements inform our stop/go criteria. The pilot aims to i) assess recruitment rate and exclusions ii) to assess VTE event rate iii) to assess progression criteria.
The overall study time will be 60 months accounting for trial set up and analysis.
Participants will be recruited to the trial from NHS UK sites.
Randomisation will be via a secure online system (staffed telephone back-up during office hours) based at CRCTU, allocating participants in a 1:1 ratio to either apixaban 2.5mg BD or placebo. A minimisation algorithm will be used within the system to ensure balance in the intervention allocations over the following variables: age (<70 or ≥70 ), sex (male or female) and cancer stage (III or IV). To avoid the possibility of the intervention allocation becoming predictable, a random element will be included in the algorithm.
- Conditions
- Thromboprophylaxis
- Being tested
- Apixaban, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called eliquis
apixaban 2.5mg twice a day for 6 months
PlaceboOther
Placebo twice a day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | apixaban 2.5 mg twice a day for 6 months Receives: Drug: Apixaban |
| Placebo | Placebo comparator | apixaban matched placebo twice a day for 6 months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (12)
Objectively confirmed VTE including all cause death
Composite of:
- 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
Measured: 6 months
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)
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Other rates of thrombosis
The following thrombosis events will be investigated:
- Arterial thromboembolism
- Visceral thromboembolism
Measured: 6 months
Survival outcomes
- VTE-related death
- All cause death
- Vascular death
Measured: 6 months
EQ-5D-5L questionnaire
Questionnaires will be collected and the five subscale scores will be transformed to the summary index value using the value set(s) appropriate for the countries the trial opens in. Index values range from -0.285 and 1.00, with a higher score indicates a better quality of life. Median index values (along with subscale scores) will then be reported for apixaban and placebo groups, along with minimal important differences.
Measured: 6 months
Time to VTE
VTE events (objectively confirmed VTE or VTE-related deaths) will be presented as a time to event outcome (time to VTE).
Measured: 6 months
Non-fatal PE
The rate of non-fatal PEs will be collected and the Odds Ratio of apixaban vs placebo will be reported.
Measured: 6 months
VTE-related death
Time to VTE-related death will be collected and the Hazard Ratio of apixaban vs. placebo will be reported.
Measured: 6 months
Global EORTC QLQ-C30 questionnaire
Questionnaires will be collected and the mean global health status /QoL scale will be reported. This scale ranges from 0-100 with a higher score indicating a higher quality of life. Median health status/QoL (along with subscale scores) values will then be reported for apixaban and placebo groups, along with minimal important differences.
Measured: 6 months
Lung cancer QLQ-LC29 questionnaire
Questionnaires will be collected and subscales will be calculated and reported. All subscales range from 0-100, with a higher score indicating a higher quality of life. Median values will then be reported for apixaban and placebo groups, along with minimal important differences
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start28 Apr 2026
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboprophylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Newnham, MBChB, MSc, MRCP, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160686
- Sponsor's protocol ID
- RG_25-043
- Other IDs
- NIHR165646
- Acronym
- THROMBO-STOP
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available after the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07160686
- Acronym / sponsor ID
- THROMBO-STOP / RG_25-043
- Conditions
- Thromboprophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,456 participants (estimated)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patients undergoing systemic anticancer therapy (SACT). VTE can be reduced using anticoagulation as thromboprophylaxis, but this is not the current standard of care for outpatients having SACT. The subcutaneous anticoagulant low molecular weight heparin can reduce VTE in lung cancer but can be inconvenient to take. Apixaban is a type of direct oral anticoagulant (DOAC) taken in tablet form and not requiring regular blood monitoring, which have a good safety profile and are licensed for other medical conditions. Whilst anticoagulants have been used for thromboprophylaxis in patients with cancer, the role of DOACs in ambulatory lung cancer patients is unanswered by the existing literature.
THROMBO-STOP is a multicentre, double blind, placebo-controlled, parallel group, two arm, phase 3 randomised clinical trial testing the efficacy of Apixaban to reduce VTE in ambulatory lung cancer patients undergoing SACT. There will be a process evaluation, acceptability study and economic evaluation. For this superiority trial, 1456 patients (728 per group) are required to have a 90% power of detecting, as significant with an alpha of 0.05 (two-sided), a decrease in the rate of VTE from 8.6% in the control group (placebo) to 4% in the intervention group (apixaban), assuming a 20% drop-out rate. The planned recruitment of 1456 patients would involve 34 sites.
THROMBO-STOP patients will be recruited over a 36-month period which includes a 12-month internal pilot among a projected 40% of sites.
Data from these elements inform our stop/go criteria. The pilot aims to i) assess recruitment rate and exclusions ii) to assess VTE event rate iii) to assess progression criteria.
The overall study time will be 60 months accounting for trial set up and analysis.
Participants will be recruited to the trial from NHS UK sites.
Randomisation will be via a secure online system (staffed telephone back-up during office hours) based at CRCTU, allocating participants in a 1:1 ratio to either apixaban 2.5mg BD or placebo. A minimisation algorithm will be used within the system to ensure balance in the intervention allocations over the following variables: age (<70 or ≥70 ), sex (male or female) and cancer stage (III or IV). To avoid the possibility of the intervention allocation becoming predictable, a random element will be included in the algorithm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: Apixabanapixaban 2.5 mg twice a day for 6 months |
| Placebo | Placebo comparator | Other: Placeboapixaban matched placebo twice a day for 6 months |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: eliquisapixaban 2.5mg twice a day for 6 months | Drug | Apixaban |
| PlaceboPlacebo twice a day for 6 months | Other | Placebo |
Primary outcome
18.3.1.1 Objectively confirmed VTE
Time frame: 6 months
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.
12 secondary outcomes
Objectively confirmed VTE including all cause death
Time frame: 6 months
Bleeding outcomes
Time frame: 6 months
Net clinical benefit
Time frame: 6 months
Proximal or distal DVT (symptomatic or incidental)
Time frame: 6 months
Other rates of thrombosis
Time frame: 6 months
Survival outcomes
Time frame: 6 months
EQ-5D-5L questionnaire
Time frame: 6 months
Time to VTE
Time frame: 6 months
Non-fatal PE
Time frame: 6 months
VTE-related death
Time frame: 6 months
Global EORTC QLQ-C30 questionnaire
Time frame: 6 months
Lung cancer QLQ-LC29 questionnaire
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available after the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophia Magwaro, BSc contact
Michael Newnham, MBChB, MSc, MRCP, PhD principal investigator
University of Birmingham
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban in people with Thromboprophylaxis, run by University of Birmingham at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Pope, PhD (+44 4146372, THROMBO-STOP@trials.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18.3.1.1 Objectively confirmed VTE (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.