NCT03838848

KN046 in Patients With Advanced Non-small Cell Lung Cancer

A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of KN046 in Patients With Advanced Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open label, multicenter study in subjects with advanced non-small cell lung cancer.

Detailed description

A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of KN046 in Subjects with Advanced Non-small Cell Lung Cancer

Conditions

• Stage IV Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	KN046	3mg/kg, Q2W, intravenous injection (IV)
DRUG	KN046	5mg/kg, Q2W, intravenous injection (IV)
DRUG	KN046	5mg/kg, Q3W, intravenous injection (IV)
DRUG	Carboplatin	AUC 5 IV Q3W; total dose calculated according to the Calvert formula, with the highest dose not exceeding 750 mg; 4 cycles.
DRUG	Pemetrexed	500 mg/m2, Q3W, intravenous injection (IV)
DRUG	Ningetinib	Oral, QD

Timeline

• Start date: 2019-05-05
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2019-02-12
• Last updated: 2023-03-02

Locations

1 site across 1 country: China