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A Study Comparing SB8 and Avastin® in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

NCT02754882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 763

Last updated 2024-12-16

Study results available
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Summary

This study is designed to establish biosimilarity of SB8, a proposed biosimilar product of bevacizumab, to EU-sourced bevacizumab, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

Conditions

Interventions

DRUG

Bevacizumab

Avastin® 15 mg/kg IV every 3 weeks on Day 1

DRUG

SB8

SB8 15 mg/kg IV every 3 weeks on Day 1

DRUG

Carboplatin

Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles

DRUG

Paclitaxel

Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Martin Reck, M.D. · LungenClinic Grosshansdorf, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-05
Primary Completion
2018-01-24
Completion
2018-10-09

Countries

  • Belarus
  • Georgia
  • Germany
  • Hungary
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02754882 on ClinicalTrials.gov