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A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer

NCT03329911 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 651

Last updated 2021-09-14

Study results available
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Summary

This is a Phase III, randomized, double blind, multicenter, active comparator, parallel two arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1706 to EU Avastin® in patients with previously untreated advanced non-squamous non-small cell lung cancer (nsNSCLC) to demonstrate clinical equivalence of BAT1706 and EU Avastin®.

Conditions

  • Non-squamous Non-small Cell Lung Cancer

Interventions

DRUG

EU Avastin®

100 mg/4 mL

DRUG

BAT1706

100 mg/4 mL

DRUG

Paclitaxel

200 mg/m²

DRUG

carboplatin

target area under the curve \[AUC\] 6 mg/mL•minute

Sponsors & Collaborators

Principal Investigators

  • Shengfeng Li · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2019-11-05
Completion
2021-05-27
FDA Drug
Yes

Countries

  • China
  • Mexico
  • South Africa
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329911 on ClinicalTrials.gov