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Completed

NCT Number: NCT02754882

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

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).

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brest Regional Oncology Dispensary, Brest, Belarus

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab

Drug

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

Other names: Avastin®

SB8

Drug

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

Other names: SB8 (A proposed bevacizumab biosimilar)

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

Other names: Taxol

Primary outcomes

  1. Percentage of Participants With Best Overall Response (Best Overall Response Rate[ORR]) by 24 Weeks

    Time frame: 24 weeks from randomisation

    The best ORR was defined as the proportion of subjects whose best overall response was either Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 during the induction treatment period by 24 weeks.

    CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Secondary outcomes

  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 is defined as the time from the date of Randomisation to the date of disease progression (progressive disease [PD]) or death regardless of the cause of death.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

  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 was defined as the time from the date of randomisation to the date of death regardless of the cause of death.

    Subjects who were alive at the time of analysis were censored at the date of last known alive.

  3. Duration of Response (DoR)

    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. Number of Participants With Treatment-related Adverse Events Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03

    Time frame: AEs were reported from the time the informed consent form (ICF) was signed until the EOT visit, approximately 24 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.

    Severity Grade of NCI-CTCAE v4.03 Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL) (Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.) Grade 3: Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self-care ADL (Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.) Grade 4: Life-threatening consequences; urgent intervention indicated Grade 5: Death related to AE

  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 (i.e., Cycle 1, 3, 5 and 7)

  6. Pharmacokinetics: Maximum Plasma Concentration [Cmax]

    Time frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)

    Maximum Plasma Concentration (Cmax) at selected cycles (i.e., Cycle 1, 3, 5 and 7)

  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.), approximately 24 months from study initiation.

    Incidence of anti-drug (bevacizumab) antibodies (ADA)

    The incidence of overall ADA results (i.e. Positive, Negative, Inconclusive) was presented by treatment group at Cycle 7 and the end of treatment (EOT). Overall ADA result was defined as below:

    • 'Positive' for a subject with treatment-induced or treatment-boosted ADA, where treatment-induced ADA indicated at least one positive result after pre-dose of Cycle 1 for subjects with negative ADA at pre-dose of Cycle 1, and treatment-boosted ADA indicated at least one positive result with higher titre level compared to pre-dose of Cycle 1 after pre-dose of Cycle 1 for subjects with positive ADA at pre-dose of Cycle 1.
    • 'Negative' for a subject without positive ADA until Cycle 7 and EOT.
    • 'Inconclusive' for a subject with positive ADA at Cycle 1 and without positive result with higher titre level observed after pre-dose of Cycle 1 up to Cycle 7 and EOT.

  8. Immunogenicity Assessments (Neutralizing Antibodies)

    Time frame: Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days.), approximately 24 months from study initiation.

    Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) The analysis was performed using the Safety Set (SAF). Overall Number of Participants Analyzed represents the number of subjects in SAF.

    The total number is not the sum of the number of subjects of each visits, since NAb results only for subjects with ADA positive against SB8 or Avastin were used for the summary.

    Number Analyzed of each visit is equal to the number of subjects with ADA positive of each visit, which is displayed in 8. Secondary Outcome: Immunogenicity Assessments (Anti-drug Antibodies).

Other outcomes

  1. Best Objective Response Rate by 11 and 17 Weeks

    Time frame: 11 weeks and 17 weeks from randomisation

    Best Objective Response Rate (ORR) by 11 weeks and 17 weeks

Sponsors and collaborators

Lead sponsor

Samsung Bioepis Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2016
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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