NCT04474119

KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Platinum-containing Chemotherapy Versus Placebo Combined With Platinum-containing Chemotherapy in First Line Advanced Squamous Non-small Cell Lung Cancer Subjects (ENREACH-L-01)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: Jiangsu Alphamab Biopharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously received systemic treatment.

Conditions

• Squamous Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	KN046	In combine therapy stage, KN046 is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.
DRUG	KN046 placebo	In combine therapy stage, KN046 placebo is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 placebo is 5 milligram per kilogram, every 2 weeks.

Timeline

• Start date: 2020-09-14
• Primary completion: 2022-08-30
• Completion: 2023-08-30
• First posted: 2020-07-16
• Last updated: 2021-11-24

Locations

1 site across 1 country: China