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

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT02754882
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Avastin® 15 mg/kg IV every 3 weeks on Day 1
  • SB8 — DRUG
    SB8 15 mg/kg IV every 3 weeks on Day 1
  • Carboplatin — DRUG
    Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
  • Paclitaxel — DRUG
    Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Study Details

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).

Key Dates

First listed
Apr 28, 2016
Start date
Jul 5, 2016
Status verified
Dec 2024
Primary completion
Jan 24, 2018
Completion
Oct 9, 2018

Study Design

Enrollment
763 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bevacizumab (Avastin)
    Avastin® + Carboplatin/Paclitaxel
  • Experimental: SB8 (A proposed bevacizumab biosimilar)
    SB8 + Carboplatin/Paclitaxel

Primary Outcome Measure

Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks [ Time Frame: 24 weeks from randomisation ]

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