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A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenecity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

NCT03390686

Description:

In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenecity.

Related Conditions:
  • Non-Squamous Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03390686

Trial Eligibility

Document

Title

  • Brief Title: A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenecity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
  • Official Title: A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Patients With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: SAMSON-II
  • NCT ID: NCT03390686

Conditions

  • Lung Cancer
  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
BevacizumabAvastinAvastin (Bevacizumab)
HD204BevacizumabHD204 (Bevacizumab biosimilar)
CarboplatinAvastin (Bevacizumab)
PaclitaxelTaxolAvastin (Bevacizumab)

Purpose

In the SAMSON-2 study, the proposed biosimilar HD204 will be compared to its reference product EU-licensed Avastin®. The aim of the study is to demonstrate equivalence of HD204 and EU-licensed Avastin® in terms of efficacy, safety, pharmacokinetics and immunogenecity.

Detailed Description

      This is a randomised, double-blind, parallel group, equivalence, multicentre Phase III study
      in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).

      Standard efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be
      compared between HD204 and bevacizumab.

Trial Arms

NameTypeDescriptionInterventions
HD204 (Bevacizumab biosimilar)ExperimentalHD204 + Carboplatin/Paclitaxel
  • HD204
  • Carboplatin
  • Paclitaxel
Avastin (Bevacizumab)Active ComparatorAvastin® + Carboplatin/Paclitaxel
  • Bevacizumab
  • Carboplatin
  • Paclitaxel

Eligibility Criteria

        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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Best Objective Response Rate by 24 weeks
Time Frame:24 weeks from randomization
Safety Issue:
Description:Any PR or CR prior to the 24th week will be marked as response

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Measure:Overall Survival (OS)
Time Frame:from the date of randomisation to the date of death up to 12 months from randomisation of the last subject
Safety Issue:
Description:OS defined as the time from Day 1 of therapy until death from any cause
Measure:Duration of Response
Time Frame:from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Safety Issue:
Description:DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Measure: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.
Safety Issue:
Description:After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.
Measure:Trough Level [Ctrough] (Pharmacokinetics)
Time Frame:Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
Safety Issue:
Description:Ctrough at selected cycles
Measure:Maximum Plasma Concentration [Cmax] (Pharmacokinetics)
Time Frame:Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.)
Safety Issue:
Description:Cmax at selected cycles
Measure:Anti-Drug Antibodies (Immunogenecity)
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.)
Safety Issue:
Description:Incidence of anti-drug (bevacizumab) antibodies (ADA)
Measure:Neutralizing Antibodies (Immunogenecity)
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.)
Safety Issue:
Description:Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Prestige Biopharma Pte Ltd

Last Updated

April 20, 2021