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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 : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Prestige Biopharma Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Cancer Non-small Cell Lung Cancer Drug: Bevacizumab Drug: HD204 Drug: Carboplatin Drug: Paclitaxel Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: HD204 (Bevacizumab biosimilar)
HD204 + Carboplatin/Paclitaxel
 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
Active Comparator: Avastin (Bevacizumab)
Avastin® + Carboplatin/Paclitaxel
 Drug: Bevacizumab
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


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 (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

  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. 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

  6. 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

  7. 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)

  8. 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)


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:

  • 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.
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): NCT03390686


Contacts
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Contact: Litha Jaison +6569246535 litha@pbpsg.com

Locations
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Sponsors and Collaborators
Prestige Biopharma Limited
Investigators
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Study Chair: Litha Jaison Prestige Biopharma Limited
More Information
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Responsible Party: Prestige Biopharma Limited
ClinicalTrials.gov Identifier: NCT03390686    
Other Study ID Numbers: SAMSON-II
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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