Trial intelligence / Profile preview

BP102 vs Avastin in First-line Advanced Non-Squamous NSCLC

NCT05169801Phase 3

Key facts

Status: Completed
Start: Jan 2018
Primary completion: Oct 2019
Countries: 1
Sponsor: Hengrui
Modality: Monoclonal Antibodies

Drugs: bevacizumab
Conditions: Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC)

Overview

Phase 3, randomised, double-blind trial of bevacizumab in Nonsquamous Non-Small Cell Lung Cancer (nsNSCLC) (2 arms), sponsored by Hengrui. Primary endpoint: Objective Response Rate at 18 weeks. Started Jan 2018; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

BP102 Arm
BP102 + Paclitaxel + Carboplatin
Avastin Arm
Avastin + Paclitaxel + Carboplatin

Who it enrols

Adult patients aged 18-75 with locally advanced, metastatic, or recurrent non-squamous NSCLC, ECOG 0-1, and no prior systemic antitumor therapy. Patients must be ALK negative. Excludes patients with CNS metastases, uncontrolled effusions, tumor cavitation, or significant cardiovascular disease.

Endpoints

Primary

Objective Response Rate18 weeks

Secondary

Progression-Free Survival41 months
Overall Survival41 months
Disease Control Rate41 months
Duration of Response41 months
Quality of Life41 months
Adverse EventsEnrollment to 28 days after permanent treatment termination
Anti-Drug Antibodies41 months
Neutralizing Antibodies41 months

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