Adverse ReactionsNCT04473703
Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in NSCLC Patients
An observational study of Adverse Reactions and Immune Checkpoint Inhibitor, run by Shanghai Chest Hospital.
Trial summary
This is a prospective, open label, single arm study. A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included . All patients will follow up for at least 1 year. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adverse Reactions, Immune Checkpoint Inhibitor, Non-Small Cell Lung Cancer Patients
- What is being tested?
- renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included. And then the basic information and the examination results will be collected.
Who may be able to join
- Be willing and able to provide written informed consent/assent for the trial;
- Lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage III~IV;
- Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least two courses;
Who cannot join
- Patients who do not have pathological diagnosis;
- Patients who can't finish the follow-up;
- The anti-PD-1, anti-PD-L1 therapy was less than two courses;
- Patients whose cancer diagnosed with small cell lung cancer.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Study of Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in Non-Small Cell Lung Cancer Patients
This is a prospective, open label, single arm study. A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included . All patients will follow up for at least 1 year. Patients with cardiac adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or during the subsequently follow-up period will randomly assigned a random number to each patient by computer random sequence. Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）.
- Conditions
- Adverse Reactions, Immune Checkpoint Inhibitor, Non-Small Cell Lung Cancer Patients, Cardiac Event
- Being tested
- renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitorDrug
Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）
| Study group | Role | What they receive |
|---|---|---|
| observation group | A total of 300 patients are expected to include in this group. And the cardiac adverse reactions related to immune checkpoint inhibitor will be observed. Receives: Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
- Primary Outcome is Major Adverse Cardiovascular Events（MACE）related to ICIs，includes: cardiovascular death, myocardial infarction(nonfatal), stroke(nonfatal), heart failure that caused readmission
Measured: 1 year
Secondary outcomes (3)
Common Terminology Criteria for Adverse Events (CTCAE)
Common Terminology Criteria for Adverse Events (CTCAE) related to ICIs, includes: arrhythmia, cardiogenic chest pain, valvular heart disease, cardiomyopathy, myocardial pericardial disease
Measured: 1 year
All cause of death
every reason that cause patient's death after ICIs treatment
Measured: 1 year
examination indexes
The examination indexes that related to myocardial damage
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse ReactionsStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xumin Hou, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473703
- Sponsor's protocol ID
- SHXKYY202005
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Cardiac Adverse Reactions Related to Immune Checkpoint Inhibitor in Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT04473703
- Acronym / sponsor ID
- SHXKYY202005
- Conditions
- Adverse Reactions, Immune Checkpoint Inhibitor, Non-Small Cell Lung Cancer Patients, Cardiac Event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 16 Jul 2020 (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.
This is a prospective, open label, single arm study. A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included . All patients will follow up for at least 1 year. Patients with cardiac adverse reactions after PD-1/PD-L1 immune checkpoint inhibitor treatment at admission or during the subsequently follow-up period will randomly assigned a random number to each patient by computer random sequence. Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Drug: renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitorA total of 300 patients are expected to include in this group. And the cardiac adverse reactions related to immune checkpoint inhibitor will be observed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 patients with primary non-small cell lung cancer treated with PD-1/PD-L1 immune checkpoint inhibitors(ICIs) are expected to included. And then the basic information and the examination results will be collected.
Key inclusion criteria (3 listed)
- Be willing and able to provide written informed consent/assent for the trial;
- Lung cancer patients whose pathological results confirmed is primary non-small cell lung cancer, stage III~IV;
- Patients received with ICIs treatment, including anti-PD-1 or anti-PD-L1 for at least two courses;
Key exclusion criteria (4 listed)
- Patients who do not have pathological diagnosis;
- Patients who can't finish the follow-up;
- The anti-PD-1, anti-PD-L1 therapy was less than two courses;
- Patients whose cancer diagnosed with small cell lung cancer.
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 |
|---|---|---|
| renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitorPatients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor） | Drug | observation group |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 1 year
a) Primary Outcome is Major Adverse Cardiovascular Events（MACE）related to ICIs，includes: cardiovascular death, myocardial infarction(nonfatal), stroke(nonfatal), heart failure that caused readmission
3 secondary outcomes
Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: 1 year
All cause of death
Time frame: 1 year
examination indexes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Reactions and Immune Checkpoint Inhibitor, run by Shanghai Chest Hospital.
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 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: status not confirmed, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunhua Xu (86-021-22200000, yhxu@shchest.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 1 year). 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 16 Jul 2020.