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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02754882
Recruitment Status : Completed
First Posted : April 28, 2016
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Lung Cancer Non-small Cell Lung Cancer Drug: Bevacizumab Drug: SB8 Drug: Carboplatin Drug: Paclitaxel Phase 3

Detailed Description:
Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between SB8 and bevacizumab.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 763 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomised, Double-blind Study to Compare the Efficacy, Safety, PK and Immunogenicity Between SB8 (Proposed Bevacizumab Biosimilar) and Avastin® in Subjects With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer
Actual Study Start Date : July 5, 2016
Actual Primary Completion Date : January 24, 2018
Actual Study Completion Date : October 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bevacizumab (Avastin)
Avastin® + Carboplatin/Paclitaxel
 Drug: Bevacizumab
Avastin® 15 mg/kg IV every 3 weeks on Day 1
Other Name: Avastin®

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
Other Name: Taxol
Experimental: SB8 (A proposed bevacizumab biosimilar)
SB8 + Carboplatin/Paclitaxel
 Drug: SB8
SB8 15 mg/kg IV every 3 weeks on Day 1
Other Name: SB8 (A proposed bevacizumab biosimilar)

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
Other Name: Taxol


Outcome Measures
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Primary Outcome Measures :
  1. Best Objective Response Rate by 24 weeks [ Time Frame: 24 weeks from randomisation ]
    Any PR or CR prior to the 24th week will be marked as response


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject ]
    PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject

  2. Overall Survival [ Time Frame: from the date of randomisation to the date of death up to 12 months from randomisation of the last subject ]
    OS from the date of randomisation to the date of death up to 12 months from randomisation of the last subject

  3. Duration of Response [ Time Frame: from documented tumour response until disease progression up to 12 months from randomisation of the last subject ]
    DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject

  4. Incidence of Treatment-related Adverse Events using CTCAE v4.03 [ Time Frame: AEs will be reported from the time the informed consent form (ICF) is signed until the EOT visit. The expected EOT visit for a final subject is approximately 30 months from study initiation. ]
    After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.

  5. Pharmacokinetics: Trough Level [Ctrough] [ Time Frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) ]
    Ctrough at selected cycles

  6. Pharmacokinetics: Maximum Plasma Concentration [Cmax] [ Time Frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) ]
    Cmax at selected cycles

  7. Immunogenicity Assessments (Anti-drug Antibodies) [ Time Frame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.) ]
    Incidence of anti-drug (bevacizumab) antibodies (ADA)

  8. Immunogenicity Assessments (Neutralizing Antibodies) [ Time Frame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.) ]
    Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)


Other Outcome Measures:
  1. Best Objective Response Rate by 11 and 17 weeks [ Time Frame: 11 weeks and 17 weeks from randomisation ]
    Best ORR by 11 weeks and 17 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
  2. Sensitizing EGFR mutations or ALK rearrangements
  3. Increased risk of bleeding determined by investigator based on radiographic / clinical findings
  4. History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02754882


Locations
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Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
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Principal Investigator: Martin Reck, M.D. LungenClinic Grosshansdorf, Germany
More Information
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02754882    
Other Study ID Numbers: SB8-G31-NSCLC
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Samsung Bioepis Co., Ltd.:
NSCLC
bevacizumab
avastin
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Bevacizumab
Carboplatin
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors