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NCT Number: NCT03390686

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

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 immunogenicity.

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This study is active but is not currently recruiting participants.

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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

Alexandrov Cancer Center, Minsk, Minsk City, Belarus

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About this study

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.

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

15 mg/kg IV every 3 weeks on Day 1

Other names: Avastin

HD204

Drug

15 mg/kg IV every 3 weeks on Day 1

Other names: Bevacizumab

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. Overall Response Rate (ORR) at Week 18

    Time frame: 18 weeks from randomization

    Percent patients within each treatment group who achieved complete response (CR) or partial response (PR) by the time of the Week 18 efficacy analysis in accordance with the RECIST 1.1. as assessed by CIR.

Secondary outcomes

  1. ORR at Week 6

    Time frame: 6 weeks from randomization

    Response at Week 6 will be evaluated by CIR to show the pattern of response

  2. ORR at Week 12

    Time frame: 12 weeks from randomization

    Response at Week 12 will be evaluated by CIR to show the pattern of response

  3. ORR at Week 18 adjusted on dose intensity

    Time frame: 18 weeks from randomization

    To compare ORR at Week 18 adjusted on dose intensity between treatment groups

  4. Duration of Response

    Time frame: from documented tumour response until disease progression up to 12 months from randomisation

    DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject

  5. 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

  6. Overall Survival (OS)

    Time frame: From the date of randomisation to the date of death up to 12 months from randomisation

    OS defined as the time from Day 1 of therapy until death from any cause

  7. Change in tumour burden from baseline

    Time frame: Up to 52 weeks from baseline

    Measured by the sum of longest diameters (SLD) of the target lesions

  8. Incidence of Treatment-related Adverse Events using CTCAE v5.0

    Time frame: From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks

    After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.

  9. Anti-Drug Antibodies (Immunogenicity)

    Time frame: Up to 52 weeks (at Baseline; end of Cycle 4 [pre-dose in cycle 5]; end of Cycle 7 [pre-dose in cycle 8]; and at EOT)

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

  10. Neutralizing Antibodies (Immunogenicity)

    Time frame: Up to 52 weeks (at Baseline; end of Cycle 4 [predose in cycle 5]; end of Cycle 7 [predose in cycle 8]; and at EOT)

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

  11. Trough Level [Ctrough] (Pharmacokinetics)

    Time frame: Up to 52 weeks (end of Cycle 1 [predose of Cycle 2], end of Cycle 3 [predose of Cycle 4], end of Cycle 5 [predose of Cycle 6] and EOT)

    Concentration observed 19 to 23 days after study drug administration

  12. Maximum Plasma Concentration [Cmax] (Pharmacokinetics)

    Time frame: Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)

    Cmax at selected cycles

  13. Area under the concentration-time curve from 0 hr to time t [AUC0-t] (Pharmacokinetics)

    Time frame: Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)

    AUC0-t at selected cycles

Sponsors and collaborators

Lead sponsor

Prestige Biopharma Limited

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jan 4, 2018
Registry last updated
May 31, 2025

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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