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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: herombopag olamine tablets

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiming Wang; Phone Number: 13783590691; Email: qimingwang1006@126.com
• Study Contact Backup: Name: zhen he; Phone Number: 13523530961; Email: 13523530961@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: herombopag olamine tablets	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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2022
• Primary Completion (Anticipated): August 20, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: February 14, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 14, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Hematologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Blood Platelet Disorders; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Thrombocytopenia
• Other Study ID Numbers: HQBP-NSCLC-II-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No