Clinical trial · Interventional
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
NCT05252091CI-TRIAL-00056687unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| herombopag olamine tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- herombopag olamine tablets
- interventionNames
- Drug: herombopag olamine tablets
Primary outcomes (1)
- measure
- Evaluate the response rate of hetrombopag
- timeFrame
- Follow-up to 28 days after the last use of herombopag
- description
- 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 outcomes (5)
- measure
- The lowest platelet value after chemotherapy
- timeFrame
- Follow-up to 28 days after the last use of herombopag
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.