NCT07101627

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Hetrombopag Tablets	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).

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-04-30
• Completion: 2027-06-30
• First posted: 2025-08-03
• Last updated: 2025-08-03

Locations

2 sites across 1 country: China