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

NCT05252091 | Unknown Phase 2

• 1 other identifier: HQBP-NSCLC-II-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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;

  Follow-up to 28 days after the last use of herombopag

• 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;

  Follow-up to 28 days after the last use of herombopag

• Incidence of adverse events

  Follow-up to 28 days after the last use of herombopag

Other Outcomes (1)

• Changes of platelet value in each visit cycle

  Follow-up to 28 days after the last use of herombopag

Study Arms (1)

herombopag olamine tablets

EXPERIMENTAL

Drug: herombopag olamine tablets

Interventions

herombopag olamine tablets DRUG

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

herombopag olamine tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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;

You may not qualify if:

• pregnant or breastfeeding women;
• Inability to understand the research nature of the research or to obtain informed consent;
• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

qiming wang

CONTACT

13783590691; qimingwang1006@126.com

zhen he

CONTACT

13523530961; 13523530961@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 23, 2022
• Study Start: February 20, 2022
• Primary Completion: August 20, 2022
• Study Completion: September 20, 2022
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share