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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: herombopag olamine tablets

• Registration Number: NCT05252091
• Lead Sponsor: Henan Cancer Hospital

Brief 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

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 Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-14
• Study First Submitted QC: 2022-02-14
• Last Update Submitted: 2022-02-14
• Study Start: 2022-02-20
• Study First Posted: 2022-02-23
• Last Update Posted: 2022-02-23
• Primary Completion: 2022-08-20
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. The patients signed the informed consent and voluntarily joined the study;
2. Age 18-75 years old, male or female;
3. 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;
4. The investigator determined that the patient could receive hetrombopag administration;
5. Thrombocytopenia of grade 2 or above occurred in the last chemotherapy cycle, defined as platelet count (PLT) ≤ 75×109/L;
6. 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

1. pregnant or breastfeeding women;
2. Inability to understand the research nature of the research or to obtain informed consent;
3. The investigator judges other circumstances that are not suitable for inclusion in the study;
4. 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.);
5. Have unstable angina pectoris, congestive heart failure, uncontrolled hypertension, uncontrolled arrhythmia or recent (within 1 year of screening) history of myocardial infarction;
6. Those with a history of blood disease or tumor bone marrow infiltration;
7. Those who received concurrent radiotherapy and those who received pelvic radiotherapy in the past;
8. Arterial or venous thrombotic events within the past 6 months;
9. There are currently uncontrollable infections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
herombopag olamine tablets	herombopag olamine tablets	-

Primary Outcome Measures

Name	Time	Method
Evaluate the response rate of hetrombopag	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.

Secondary Outcome Measures

Name	Time	Method
The duration of platelets ≤50×109/L;	Follow-up to 28 days after the last use of herombopag	The duration of platelets ≤50×109/L;
The lowest platelet value after chemotherapy	Follow-up to 28 days after the last use of herombopag	The lowest platelet value after chemotherapy
Platelet recovery to the highest value after chemotherapy;	Follow-up to 28 days after the last use of herombopag	Platelet recovery to the highest value after chemotherapy;
The time for platelets to recover to more than 100×109/L;	Follow-up to 28 days after the last use of herombopag	The time for platelets to recover to more than 100×109/L;
Incidence of adverse events	Follow-up to 28 days after the last use of herombopag	Incidence of adverse events