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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05252091
• Other study ID #: HQBP-NSCLC-II-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 20, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: February 2022
• Source: Henan Cancer Hospital
• Contact: qiming wang
• Phone: 13783590691
• Email: qimingwang1006[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer
• Thrombocytopenia

Intervention

Drug:
• herombopag olamine tablets
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Henan Cancer Hospital	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of platelet value in each visit cycle	Changes of platelet value in each visit cycle	Follow-up to 28 days after the last use of herombopag
Primary	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	The lowest platelet value after chemotherapy	The lowest platelet value after chemotherapy	Follow-up to 28 days after the last use of herombopag
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of adverse events	Incidence of adverse events	Follow-up to 28 days after the last use of herombopag