NCT07303881

Golidocitinib for Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer

A Clinical Study Evaluating the Safety and Efficacy of Golidocitinib in Patients With Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm clinical trial designed to evaluate the safety and efficacy of golidocitinib in patients with refractory, immune-related hematologic toxicity in advanced lung cancer.

Detailed description

This is a single-center, single-arm clinical trial designed to evaluate the safety and efficacy of golixitinib in patients with advanced lung cancer exhibiting refractory immune-related hematologic toxicity. In this study, refractory immune-related hematologic toxicity was defined as grade ≥3 hematologic toxicity in patients with advanced lung cancer receiving immune checkpoint inhibitor therapy, unresponsive to treatment with hormones/hematopoietic factors/blood transfusions, and with a positive antinuclear antibody (ANA) profile (anti-SSA antibody). Patients with refractory immune-related hematologic toxicity will primarily receive golixitinib. This study comprises two parts: Part A (dose escalation): This part will include patients with refractory immune-related hematologic toxicity to determine the safety and initial hematologic toxicity mitigation of golixitinib in this population, and to determine the recommended dose for Part B (dose extension). Part B (dose extension): This part will include patients with refractory immune-related hematologic toxicity to further explore the hematologic toxicity mitigation and safety of the selected dose of golixitinib in this population. Based on the BOIN dose escalation and Simon two-stage efficacy assessment design, if the dose of golixitinib used in Part B is 75 mg, the total number of subjects to be included in Parts A and B is 10; if the dose of golixitinib used in Part B is 150 mg, the total number of subjects to be included in Parts A and B is 13-16.

Conditions

• IrAE
• Hematologic Disorder
• Lung Cancer (Locally Advanced or Metastatic)

Interventions

Type	Name	Description
DRUG	golidocitinib	Golidocitinib treatment can be discontinued once clinical remission is achieved, with a maximum maintenance period of 12 weeks.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-06-01
• Completion: 2028-12-01
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: China