A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy

NCT07101627 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-CTIT-II-013
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the efficacy and safety of Hetrombopag in secondary prevention of thrombocytopenia caused by lung cancer treatment

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade 3 and Higher Thrombocytopenia

  Incidence of platelet count ≤ 50 × 10\^9/L

  One cycle of treatment(21 days)

Secondary Outcomes (8)

• Incidence of Grade 2 and Higher Thrombocytopenia

  One cycle of treatment(21 days)

• Platelet count nadir

  One cycle of treatment(21 days)

• The time it takes for PLT to recover from the lowest value to ≥100×10^9/L

  One cycle of treatment(21 days)

• Duration of Grade 3 or Higher Thrombocytopenia

  One cycle of treatment(21 days)

• Platelet count on the day before the next cycle of chemotherapy

  The day before the next cycle of chemotherapy

Study Arms (2)

Hetrombopag Tablets

EXPERIMENTAL

patients will receive oral administration of hetrombopag, 7.5 mg/day, for 14 days from the first day after the end of chemotherapy in this cycle.

Drug: Hetrombopag Tablets

Hetrombopag Simulated Tablets

PLACEBO COMPARATOR

patients in the control group began to orally take hetrombopag simulated tablets 7.5 mg/day for 14 days on the first day after the end of chemotherapy in this cycle.

Drug: Hetrombopag Tablets

Interventions

Hetrombopag Tablets DRUG

Stage 1: After screening and enrollment, patients will receive oral administration of hetrombopag, 7.5 mg/day, for 14 days from the first day after the end of chemotherapy in this cycle. Stage 2: Patients who met the inclusion criteria were randomized 1:1 to the experimental group and the control group after enrollment. Patients in the experimental group began to orally take hetrombopag 7.5 mg/day for 14 days on the first day after the end of chemotherapy in this cycle; patients in the control group began to orally take hetrombopag simulated tablets 7.5 mg/day for 14 days on the first day after the end of chemotherapy in this cycle. Randomization was stratified by concomitant immunotherapy (yes versus no) and chemotherapy with gemcitabine plus platinum (yes versus no).

Hetrombopag Simulated Tablets; Hetrombopag Tablets

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years, gender is not limited.
• Patients with histopathologically confirmed metastatic lung cancer.
• Receiving platinum- or gemcitabine-based (21-day chemotherapy cycles) antineoplastic therapy with an anticipated treatment of ≥ 2 cycles.
• ECOG PS score 0-2.
• Platelet count \< 75 × 10\^9/L in previous cycle due to same lung cancer treatment regimen.
• PLT between 100-200 × 10\^9/L prior to enrollment.
• Primary organ function normal:
• ① Bone marrow hematopoiesis: ANC ≥ 1.5×10\^9/L; hemoglobin ≥ 8 g/dL;
• ② Liver and kidney function: total bilirubin ≤ 1.5 ULN; ALT, AST ≤ 2.5 ULN; if liver metastasis is present, ALT, AST ≤ 5 ULN; serum creatinine ≤ 1.5 ULN or creatinine clearance \> 60 mL/min (Cockcroft-Gault);
• ③ Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 ULN
• Expected survival ≥ 3 months.
• Female subjects of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose and not breastfeeding and must agree to use effective contraception during the trial and for 7 days after the last dose of study drug; male subjects with partners of childbearing potential should be surgically sterilized or agree to use effective contraception during the trial and for 7 days after the last dose of study drug and are not allowed to donate sperm during the study.
• Voluntarily join this study, sign informed consent form, have good compliance and are willing to cooperate in follow-up.

You may not qualify if:

• Subjects will not enter this study if they have any of the following characteristics or conditions:
• Pregnant or lactating women.
• Inability to understand the investigational nature of the study or lack of informed consent.
• Associated hematopoietic disorders, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative disorders, multiple myeloma, and myelodysplastic syndrome.
• Other diseases causing thrombocytopenia other than thrombocytopenia caused by anti-tumor therapy (CTIT) within 6 months before screening, including but not limited to chronic liver disease, hypersplenism and infection.
• Presence of active uncontrolled infection.
• Tumor bone marrow invasion or bone marrow metastasis.
• Any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism) within 6 months prior to Screening, or clinical symptoms and history suggestive of thrombophilia.
• Cardiac disorders, including Grade 3/4 congestive heart failure, cardiac arrhythmia or myocardial infarction requiring medication, or cardiac arrhythmia known to increase the risk of thrombotic events (eg, atrial fibrillation), or prolongation of the subject 's corrected QT interval (QTc) within 3 months prior to Screening.
• Thrombocytopenia not due to antineoplastic therapy.
• Known hypersensitivity to TPO.
• Patients accompanied by severe bleeding symptoms or with clear clinical manifestations of bleeding tendency, such as gastrointestinal tract or cerebral hemorrhage.
• Concurrent use of other drugs that may affect platelet count (traditional Chinese medicine, proplatelet, antiplatelet, etc.)

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (2)

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

hetrombopag

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shengxiang Ren, Pro.

CONTACT

13816756732; harry_ren@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

CN (2)