NCT04258033

A Study of PLB1001 in Non-small Cell Lung Cancer With c-Met Dysregulation(KUNPENG)

A Phase II, Open-label, Multicenter and Multi-cohorts Study to Evaluate the Efficacy and Safety of PLB1001 in Advanced Non-small Cell Lung Cancer With c-Met Dysregulation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Beijing Pearl Biotechnology Limited Liability Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label, multicenter and multi-cohorts study of PLB1001 administered orally twice daily to locally advanced/metastatic NSCLC patients with c-Met dysregulation.

Detailed description

PLB1001 will be administrated 200mg twice daily. The treatment will be discontinued for the patients who experience disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. A cycle of study treatment will be defined as 28 days of continuous dosing. The study includes 4 cohorts.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	PLB1001	PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.

Timeline

• Start date: 2020-01-17
• Primary completion: 2024-05-14
• Completion: 2025-12-31
• First posted: 2020-02-06
• Last updated: 2025-02-06

Locations

1 site across 1 country: China