Non-small Cell Lung CancerPhase 2NCT05252091
An Exploratory Study of Herombopag for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in NSCLC
A Phase 2 study testing herombopag olamine tablets in people with Non-small Cell Lung Cancer, run by Henan Cancer Hospital.
Trial summary
The purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- herombopag olamine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2022to 20 Sep 2022
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients signed the informed consent and voluntarily joined the study;
- Age 18-75 years old, male or female;
- Patients with stage IIIb-IV non-small cell lung cancer diagnosed by histopathology or cytology, who have received and will continue to receive carboplatin-based chemotherapy combined with pemetrexed or nab-paclitaxel, combined with immune checkpoint inhibitors ( ICIs) treatment;
- The investigator determined that the patient could receive hetrombopag administration;
- Thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (PLT) ≤ 75×109/L;
- The values of laboratory tests performed for screening shall meet the following criteria:
- 1) Blood routine examination: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×109/L; c) Platelet count (PLT) ≥ 80×109/L; 2) Biochemical tests: a) AST and ALT ≤ 3 times ULN (if there is tumor liver metastasis, ≤ 5 times ULN); b) TBiL ≤ 2 times ULN; c) Cr ≤ 2 times ULN, or creatinine clearance (CrCL) ≥60 mL/min (Cockcroft-Gault formula); 7. Life expectancy at screening ≥12 weeks; 8. ECOG: 0-1; 9. The main organ functions are normal, and there are no serious complications;
Who cannot join
- pregnant or breastfeeding women;
- Inability to understand the research nature of the research or to obtain informed consent;
- The investigator judges other circumstances that are not suitable for inclusion in the study;
- Thrombocytopenia caused by other causes other than those caused by chemotherapy or immunotherapy (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
- Have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction;
- Those with a history of blood disease or tumor bone marrow infiltration;
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- Those who received concurrent radiotherapy and those who received pelvic radiotherapy in the past;
- Arterial or venous thrombotic events within the past 6 months;
- There are currently uncontrollable infections.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Exploratory Clinical Study of Herombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in Non-small Cell Lung Cancer
The purpose of this study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer
Read the detailed description
To observe and evaluate the safety and efficacy of the TPO receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-small cell lung cancer.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- herombopag olamine tablets
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herombopag olamine tabletsDrug
The first day of chemotherapy was d1, and the drug was started from d-5, 5 days before chemotherapy, with oral herombopag 5 mg/day for a maximum of 14 days. After chemotherapy, when the thrombocytopenia rises to ≥200×109/L, drug discontinuation can be considered
| Study group | Role | What they receive |
|---|---|---|
| herombopag olamine tablets | Experimental | Not described Receives: Drug: herombopag olamine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the response rate of hetrombopag
response if all of the following criteria are met: 1. No need for platelet transfusion 2. No need to reduce chemotherapy drug dose due to thrombocytopenia 3. No need to delay chemotherapy due to thrombocytopenia) Note: chemotherapy drug dose reduction It was defined as reducing the dose of the original chemotherapy drug by ≥20%, and chemotherapy delay was defined as delaying chemotherapy by >7 days.
Measured: Follow-up to 28 days after the last use of herombopag
Secondary outcomes (5)
The lowest platelet value after chemotherapy
The lowest platelet value after chemotherapy
Measured: Follow-up to 28 days after the last use of herombopag
Platelet recovery to the highest value after chemotherapy;
Platelet recovery to the highest value after chemotherapy;
Measured: Follow-up to 28 days after the last use of herombopag
The duration of platelets ≤50×109/L;
The duration of platelets ≤50×109/L;
Measured: Follow-up to 28 days after the last use of herombopag
The time for platelets to recover to more than 100×109/L;
The time for platelets to recover to more than 100×109/L;
Measured: Follow-up to 28 days after the last use of herombopag
Incidence of adverse events
Incidence of adverse events
Measured: Follow-up to 28 days after the last use of herombopag
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion20 Aug 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252091
- Sponsor's protocol ID
- HQBP-NSCLC-II-001
- Status last verified
- Feb 2022
- First submitted
- 14 Feb 2022
- Last updated
- 23 Feb 2022
- 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 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Herombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05252091
- Acronym / sponsor ID
- HQBP-NSCLC-II-001
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 20 Aug 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 23 Feb 2022 (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 study is to explore the safety and efficacy of herombopag olamine tablets for thrombocytopenia induced by chemotherapy combined with immunotherapy in non-small cell lung cancer
Detailed description
To observe and evaluate the safety and efficacy of the TPO receptor agonist herombopag for the secondary prevention of thrombocytopenia caused by chemotherapy combined with immunotherapy in non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| herombopag olamine tablets | Experimental | Drug: herombopag olamine tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patients signed the informed consent and voluntarily joined the study;
- Age 18-75 years old, male or female;
- Patients with stage IIIb-IV non-small cell lung cancer diagnosed by histopathology or cytology, who have received and will continue to receive carboplatin-based chemotherapy combined with pemetrexed or nab-paclitaxel, combined with immune checkpoint inhibitors ( ICIs) treatment;
- The investigator determined that the patient could receive hetrombopag administration;
- Thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (PLT) ≤ 75×109/L;
Key exclusion criteria (9 listed)
- pregnant or breastfeeding women;
- Inability to understand the research nature of the research or to obtain informed consent;
- The investigator judges other circumstances that are not suitable for inclusion in the study;
- Thrombocytopenia caused by other causes other than those caused by chemotherapy or immunotherapy (such as chronic liver disease, sepsis, disseminated intravascular coagulation, immune thrombocytopenia, etc.);
- Have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction;
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 |
|---|---|---|
| herombopag olamine tabletsThe first day of chemotherapy was d1, and the drug was started from d-5, 5 days before chemotherapy, with oral herombopag 5 mg/day for a maximum of 14 days. After chemotherapy, when the thrombocytopenia rises to ≥200×109/L, drug discontinuation can be considered | Drug | herombopag olamine tablets |
Primary outcome
Evaluate the response rate of hetrombopag
Time frame: Follow-up to 28 days after the last use of herombopag
response if all of the following criteria are met: 1. No need for platelet transfusion 2. No need to reduce chemotherapy drug dose due to thrombocytopenia 3. No need to delay chemotherapy due to thrombocytopenia) Note: chemotherapy drug dose reduction It was defined as reducing the dose of the original chemotherapy drug by ≥20%, and chemotherapy delay was defined as delaying chemotherapy by >7 days.
5 secondary outcomes
The lowest platelet value after chemotherapy
Time frame: Follow-up to 28 days after the last use of herombopag
Platelet recovery to the highest value after chemotherapy;
Time frame: Follow-up to 28 days after the last use of herombopag
The duration of platelets ≤50×109/L;
Time frame: Follow-up to 28 days after the last use of herombopag
The time for platelets to recover to more than 100×109/L;
Time frame: Follow-up to 28 days after the last use of herombopag
Incidence of adverse events
Time frame: Follow-up to 28 days after the last use of herombopag
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing herombopag olamine tablets in people with Non-small Cell Lung Cancer, run by Henan Cancer 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 7 inclusion and 9 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 23 Feb 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 qiming wang (13783590691, qimingwang1006@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the response rate of hetrombopag (time frame: Follow-up to 28 days after the last use of herombopag). 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 23 Feb 2022.