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Trial record 1 of 1 for:    samson | Recruiting, Not yet recruiting Studies | Lung Cancer | Ukraine
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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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390686
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Prestige Biopharma Pte Ltd

Tracking Information
First Submitted Date  ICMJE December 28, 2017
First Posted Date  ICMJE January 4, 2018
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE November 15, 2019
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
Best Objective Response Rate by 24 weeks [ Time Frame: 24 weeks from randomization ]
Any PR or CR prior to the 24th week will be marked as response
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2018)
  • 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
  • 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 ]
    OS defined as the time from Day 1 of therapy until death from any cause
  • 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
  • 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.
  • Trough Level [Ctrough] (Pharmacokinetics) [ Time Frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) ]
    Ctrough at selected cycles
  • Maximum Plasma Concentration [Cmax] (Pharmacokinetics) [ Time Frame: Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) ]
    Cmax at selected cycles
  • 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.) ]
    Incidence of anti-drug (bevacizumab) antibodies (ADA)
  • 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.) ]
    Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Cancer
  • Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Bevacizumab
    15 mg/kg IV every 3 weeks on Day 1
    Other Name: Avastin
  • Drug: HD204
    15 mg/kg IV every 3 weeks on Day 1
    Other Name: Bevacizumab
  • 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
Study Arms  ICMJE
  • Experimental: HD204 (Bevacizumab biosimilar)
    HD204 + Carboplatin/Paclitaxel
    Interventions:
    • Drug: HD204
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Active Comparator: Avastin (Bevacizumab)
    Avastin® + Carboplatin/Paclitaxel
    Interventions:
    • Drug: Bevacizumab
    • Drug: Carboplatin
    • Drug: Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 3, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa S Park +6569246535 lisa@pbpsg.com
Listed Location Countries  ICMJE Ukraine,   Belarus,   Bulgaria,   Croatia,   Georgia,   Greece,   Hungary,   India,   Latvia,   Malaysia,   Philippines,   Poland,   Russian Federation,   Serbia,   Slovakia,   Thailand,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03390686
Other Study ID Numbers  ICMJE Samson-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Prestige Biopharma Pte Ltd
Study Sponsor  ICMJE Prestige Biopharma Pte Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Lisa S Park Prestige Biopharma Pte Ltd
PRS Account Prestige Biopharma Pte Ltd
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP