NCT04830813

Phase 3 Clinical Study of Chiauranib Capsule in Patients With Small-cell Lung Cancer

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Clinical Study of Chiauranib Capsule in Patients With Progressed or Relapsed Small-cell Lung Cancer After 2 Lines Chemotherapy (CHIS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Chiauranib , which simultaneously targets against VEGFR/Aurora B/CSF-1R, several key kinases involved in tumor angiogenesis, tumor cell mitosis, and chronic inflammatory microenvironment.

Detailed description

Chiauranib is a novel orally active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRa and c-Kit), mitosis-related kinase Aurora B and chronic inflammationrelated kinase CSF-1R in a high potency manner with the IC50 at a single-digit nanomolar range. In particular, Chiauranib showed very high selectivity in the kinase inhibition profile with little activity on off-target non-receptor kinases, proteins, GPCR and ion channels, indicative of a better drug safety profile in terms of clinical relevance. In July 2017, the sponsor initiated a phase Ib/II trial (CAR105). As of October 9, 2020, a total of 42 subjects entered the safety analysis and 41 subjects entered the efficacy analysis. The results of the phased trial analysis show the preliminary efficacy of this product in the treatment of SCLC at ≥3 lines. This clinical trial is studying the efficacy and safety of chiauranib works in treating patients with relapsed or refractory small cell lung cancer, in the meantime, exploreing the latent biomarkers accompany with chiauranib, as well as the relevancy of which and clinical benefit.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Chiauranib	Patients take Chiauranib capsules 50mg, orally once daily, 21 days as a cycle until objective disease progression.
DRUG	Placebo	Participants received Chiauranib placebo capsule matching Chiauranib orally once daily until objective disease progression.

Timeline

• Start date: 2021-03-05
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2021-04-05
• Last updated: 2024-12-09

Locations

1 site across 1 country: China