Lung CancerPhase 2NCT07101627
A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy
A Phase 2 study testing Hetrombopag Tablets in people with Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of Hetrombopag in secondary prevention of thrombocytopenia caused by lung cancer treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Hetrombopag Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be enrolled in the study：
- 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.
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- 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.
Who cannot join
- 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.
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- 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.)
- Other conditions not suitable for inclusion in the study judged by the investigator.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009
Bo Shen, Pro., 13913910555, shenbo987@126.com
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai, Shanghai Municipality, 200433
Shengxiang Ren, Pro., 13816756732, harry_ren@126.com
About this study
To evaluate the efficacy and safety of Hetrombopag in secondary prevention of thrombocytopenia caused by lung cancer treatment
Read the detailed description
The study was divided into 2 study periods, Stage 1 was a prospective, single-arm study design and Stage 2 was a prospective, randomized, double-blind, placebo-controlled study design. According to the results of Phase 1 study, Phase 2 study design and sample size were confirmed.
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).
- Conditions
- Lung Cancer
- Being tested
- Hetrombopag Tablets
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag TabletsDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hetrombopag Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3 and Higher Thrombocytopenia
Incidence of platelet count ≤ 50 × 10^9/L
Measured: One cycle of treatment(21 days)
Secondary outcomes (8)
Incidence of Grade 2 and Higher Thrombocytopenia
Incidence of platelet count ≤ 75 × 10^9/L
Measured: One cycle of treatment(21 days)
Platelet count nadir
Platelet count nadir
Measured: One cycle of treatment(21 days)
The time it takes for PLT to recover from the lowest value to ≥100×10^9/L
The time it takes for PLT to recover from the lowest value to ≥100×10^9/L
Measured: One cycle of treatment(21 days)
Duration of Grade 3 or Higher Thrombocytopenia
Duration of platelet count ≤ 50 × 10^9/L
Measured: One cycle of treatment(21 days)
Platelet count on the day before the next cycle of chemotherapy
Platelet count on the day before the next cycle of chemotherapy
Measured: The day before the next cycle of chemotherapy
Proportion of patients with a delay, dose reduction, suspension, or regimen modification of their next cycle of antineoplastic therapy due to thrombocytopenia
Proportion of patients with a delay, dose reduction, suspension, or regimen modification of their next cycle of antineoplastic therapy due to thrombocytopenia
Measured: One cycle of treatment(21 days)
Proportion of Salvage Patients
Proportion of Salvage(Platelet transfusion, interleukin-11, recombinant human thrombopoietin) Patients
Measured: One cycle of treatment(21 days)
Safety(The occurrence of any AEs )
Adverse events (evaluated using NCI CTCAE Version 5.0), laboratory tests, vital signs, electrocardiograms, and physical examinations, as well as the incidence and severity of bleeding events
Measured: One cycle of treatment(21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Ren Shengxiang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101627
- Sponsor's protocol ID
- MA-CTIT-II-013
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Study of Hetrombopag in the Prevention of Thrombocytopenia Caused by Lung Cancer Therapy
- ClinicalTrials.gov ID
- NCT07101627
- Acronym / sponsor ID
- MA-CTIT-II-013
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of Hetrombopag in secondary prevention of thrombocytopenia caused by lung cancer treatment
Detailed description
The study was divided into 2 study periods, Stage 1 was a prospective, single-arm study design and Stage 2 was a prospective, randomized, double-blind, placebo-controlled study design. According to the results of Phase 1 study, Phase 2 study design and sample size were confirmed.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag Tablets | Experimental | Drug: Hetrombopag Tabletspatients 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. |
| Hetrombopag Simulated Tablets | Placebo comparator | Drug: Hetrombopag Tabletspatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must meet all of the following inclusion criteria to be enrolled in the study：
- 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
Key exclusion criteria (14 listed)
- Subjects will not enter this study if they have any of the following characteristics or conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hetrombopag TabletsStage 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). | Drug | Hetrombopag Simulated Tablets, Hetrombopag Tablets |
Primary outcome
Incidence of Grade 3 and Higher Thrombocytopenia
Time frame: One cycle of treatment(21 days)
Incidence of platelet count ≤ 50 × 10^9/L
8 secondary outcomes
Incidence of Grade 2 and Higher Thrombocytopenia
Time frame: One cycle of treatment(21 days)
Platelet count nadir
Time frame: One cycle of treatment(21 days)
The time it takes for PLT to recover from the lowest value to ≥100×10^9/L
Time frame: One cycle of treatment(21 days)
Duration of Grade 3 or Higher Thrombocytopenia
Time frame: One cycle of treatment(21 days)
Platelet count on the day before the next cycle of chemotherapy
Time frame: The day before the next cycle of chemotherapy
Proportion of patients with a delay, dose reduction, suspension, or regimen modification of their next cycle of antineoplastic therapy due to thrombocytopenia
Time frame: One cycle of treatment(21 days)
Proportion of Salvage Patients
Time frame: One cycle of treatment(21 days)
Safety(The occurrence of any AEs )
Time frame: One cycle of treatment(21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hetrombopag Tablets in people with Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengxiang Ren, Pro. (13816756732, harry_ren@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3 and Higher Thrombocytopenia (time frame: One cycle of treatment(21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.