NCT04466917

A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).

Detailed description

Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. After randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.

Conditions

• Metastatic Non-small Cell Lung Cancer (NSCLC)
• Non-squamous NSCLC

Interventions

Type	Name	Description
DRUG	ABP 215	ABP 215 will be administered at a dose of 15 mg/kg IV
DRUG	Bevacizumab	Bevacizumab will be administered at a dose of 15 mg/kg IV
DRUG	Paclitaxel	Paclitaxel will be administered 175 mg/m2 IV
DRUG	Carboplatin	Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV

Timeline

• Start date: 2021-05-15
• Primary completion: 2022-11-13
• Completion: 2022-11-13
• First posted: 2020-07-10
• Last updated: 2023-07-03

Regulatory

• FDA-regulated drug study