Not Yet RecruitingPhase 2

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

China149 participantsStarted 2025-08-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. Expected survival ≥ 3 months.

✕. 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.

Incidence of Grade 3 and Higher Thrombocytopenia

Timeframe: One cycle of treatment(21 days)

NCT IDNCT07101627

SponsorShanghai Pulmonary Hospital, Shanghai, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-30

Shengxiang Ren, Pro.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. Expected survival ≥ 3 months.

✕. 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.