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

  • STATUS
    Recruiting
  • End date
    Dec 18, 2023
  • participants needed
    500
  • sponsor
    Prestige Biopharma Limited
Updated on 18 June 2022
paclitaxel
cancer
measurable disease
lung cancer
carboplatin
bevacizumab
carboplatin/paclitaxel
lung carcinoma
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer

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.

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.

Details
Condition Lung Cancer, Non-small Cell Lung Cancer
Treatment carboplatin, Paclitaxel, bevacizumab, HD204
Clinical Study IdentifierNCT03390686
SponsorPrestige Biopharma Limited
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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