An Exploratory Study of Herombopag for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in NSCLC

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Exploratory Clinical Study of Herombopag Olamine Tablets for Thrombocytopenia Induced by Chemotherapy Combined With Immunotherapy in Non-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: herombopag olamine tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: herombopag olamine tablets<br> | Drug: herombopag olamine tablets<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Follow-up to 28 days after the last use of herombopag | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lowest platelet value after chemotherapy | The lowest platelet value after chemotherapy | 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; | 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; | 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; | Follow-up to 28 days after the last use of herombopag | 
| Incidence of adverse events | Incidence of adverse events | Follow-up to 28 days after the last use of herombopag |