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

S

Samsung

Status and phase

Completed
Phase 3

Conditions

Non-small Cell Lung Cancer
Lung Cancer

Treatments

Drug: SB8
Drug: Paclitaxel
Drug: Carboplatin
Drug: Bevacizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02754882
SB8-G31-NSCLC

Details and patient eligibility

About

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).

Full description

Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.

Enrollment

763 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged ≥ 18 years
  • ECOG performance status of 0-1
  • Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
  • At least one measurable lesion according to RECIST v1.1.
  • Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters

Exclusion criteria

  • Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
  • Sensitizing EGFR mutations or ALK rearrangements
  • Increased risk of bleeding determined by investigator based on radiographic / clinical findings
  • History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

763 participants in 2 patient groups

Bevacizumab (Avastin)
Active Comparator group
Description:
Avastin® + Carboplatin/Paclitaxel
Treatment:
Drug: Bevacizumab
Drug: Paclitaxel
Drug: Carboplatin
SB8 (A proposed bevacizumab biosimilar)
Experimental group
Description:
SB8 + Carboplatin/Paclitaxel
Treatment:
Drug: Paclitaxel
Drug: Carboplatin
Drug: SB8

Trial contacts and locations

105

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Data sourced from clinicaltrials.gov

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