Lung CancerNCT06950697
Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
An observational study of Lung Cancer and Venous Thromboembolism, run by Beijing Chao Yang Hospital at 5 sites in China.
Trial summary
The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Venous Thromboembolism, Arterial Thromboembolism
- How many people
- 2,400 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2019to 1 Dec 2027
- How long will I take part?
- 30 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with histopathologically confirmed lung cancer who were treated with immune checkpoint inhibitors between January 1, 2019, and December 31, 2026.
Who may be able to join
- Age ≥18 years
- Histopathologically confirmed lung cancer diagnosis at enrollment
- Received at least one dose of a China-approved lung cancer immune checkpoint inhibitor
- Signed informed consent form
Who cannot join
- Presence of two or more primary cancers
- Missing data for key variables
- Inability to comply with follow-up requirements
- Presence of VTE/ATE at the time of ICI initiation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University
Beijing
- Recruiting
Beijing Luhe Hospital, Capital Medical University
Beijing
Yuan Yuan, 86+18801266701, yuanyuaninternist@163.com
- Recruiting
China-japan Friendship Hospital
Beijing
Meng Yang, 86+18618307980, yangm_zoe@163.com
- Recruiting
The Fourth Hospital of Inner Mongolia Autonomous Region
Hohhot, Inner Mongolia
Jing Zhao, 86+15540718272, 171489419@qq.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yanping Su, 86+13938270842, suyanping2011@163.com
About this study
The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are:
- What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors?
- What are the risk factors and biomarkers for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors?
- What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors?
Researchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE/ATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.
- Conditions
- Lung Cancer, Venous Thromboembolism, Arterial Thromboembolism, Immune Checkpoint Inhibitors (ICIs)
- Medical subject headings
- Lung Neoplasms, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With immune checkpoint inhibitor-associated venous thromboembolism | Patients with immune checkpoint inhibitor-associated venous thromboembolism would be included in this group | |
| Without immune checkpoint inhibitor-associated venous thromboembolism | Patients without immune checkpoint inhibitor-associated venous thromboembolism would be included in this group | |
| With immune checkpoint inhibitor-associated arterial thromboembolism | Patients with immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group | |
| Without immune checkpoint inhibitor-associated arterial thromboembolism | Patients without immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism
From the administration of the first dose of immune checkpoint inhibitors until death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, symptomatic and incidentally detected arterial thromboembolism and venous thromboembolism events that occur during this period are included.
Measured: Begin on the date of the first ICI dose and end upon death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, whichever comes first, assessed up to 96 months.
Secondary outcomes (3)
Progression-free survival
Progression-Free Survival refers to the time from the start of immune checkpoint inhibitor therapy until the disease progresses or the patient dies, whichever occurs first.
Measured: From the date of the administration of the first dose of immune checkpoint inhibitors until the date of disease progression, death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.
Overall survival
Overall survival refers to the time from the start of immune checkpoint inhibitor therapy until the patient dies or the cutoff date, whichever occurs first."
Measured: From the date of the administration of the first dose of immune checkpoint inhibitors until the date of death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.
Objective response rate
Objective Response Rate (ORR) refers to the proportion of patients who experience a confirmed reduction in tumor size or complete disappearance of the tumor, as assessed by standard criteria such as RECIST (Response Evaluation Criteria in Solid Tumors). It includes both complete responses (CR) and partial responses (PR) and is typically reported as a percentage of the total treated population.
Measured: From the date of the first dose of immune checkpoint inhibitors until the best efficacy is achieved, assessed up to 96 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jan 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, The Fourth Hospital of Inner Mongolia Autonomous Region
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950697
- Sponsor's protocol ID
- CYFH202212
- Status last verified
- Mar 2026
- First submitted
- 8 Apr 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
- ClinicalTrials.gov ID
- NCT06950697
- Acronym / sponsor ID
- CYFH202212
- Conditions
- Lung Cancer, Venous Thromboembolism, Arterial Thromboembolism, Immune Checkpoint Inhibitors (ICIs)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Capital Medical University, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, The Fourth Hospital of Inner Mongolia Autonomous Region
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Apr 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 purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are:
- What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors?
- What are the risk factors and biomarkers for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors?
- What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors?
Researchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE/ATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| With immune checkpoint inhibitor-associated venous thromboembolism | – | –Patients with immune checkpoint inhibitor-associated venous thromboembolism would be included in this group |
| Without immune checkpoint inhibitor-associated venous thromboembolism | – | –Patients without immune checkpoint inhibitor-associated venous thromboembolism would be included in this group |
| With immune checkpoint inhibitor-associated arterial thromboembolism | – | –Patients with immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group |
| Without immune checkpoint inhibitor-associated arterial thromboembolism | – | –Patients without immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histopathologically confirmed lung cancer who were treated with immune checkpoint inhibitors between January 1, 2019, and December 31, 2026.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Histopathologically confirmed lung cancer diagnosis at enrollment
- Received at least one dose of a China-approved lung cancer immune checkpoint inhibitor
- Signed informed consent form
Key exclusion criteria (4 listed)
- Presence of two or more primary cancers
- Missing data for key variables
- Inability to comply with follow-up requirements
- Presence of VTE/ATE at the time of ICI initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism
Time frame: Begin on the date of the first ICI dose and end upon death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, whichever comes first, assessed up to 96 months.
From the administration of the first dose of immune checkpoint inhibitors until death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, symptomatic and incidentally detected arterial thromboembolism and venous thromboembolism events that occur during this period are included.
3 secondary outcomes
Progression-free survival
Time frame: From the date of the administration of the first dose of immune checkpoint inhibitors until the date of disease progression, death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.
Overall survival
Time frame: From the date of the administration of the first dose of immune checkpoint inhibitors until the date of death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months.
Objective response rate
Time frame: From the date of the first dose of immune checkpoint inhibitors until the best efficacy is achieved, assessed up to 96 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 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Venous Thromboembolism, run by Beijing Chao Yang Hospital at 5 sites in China.
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 4 inclusion and 4 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Yuhui Zhang (86+13520108369, zhangyhcy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism (time frame: Begin on the date of the first ICI dose and end upon death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, whichever comes first, assessed up to 96 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 30 Apr 2026.