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
    Nov 30, 2021
  • participants needed
    500
  • sponsor
    Prestige Biopharma Pte Ltd
Updated on 30 April 2021
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 Non-Small Cell Lung Cancer, Pulmonary Disease, Lung Neoplasm, Bronchial Neoplasm, Lung Cancer, Lung Disease, nsclc, carcinoma lung, lung carcinoma
Treatment carboplatin, Paclitaxel, bevacizumab, HD204
Clinical Study IdentifierNCT03390686
SponsorPrestige Biopharma Pte Ltd
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Lung Neoplasm or Bronchial Neoplasm or Pulmonary Disease or Lung Cancer or Non-Small Cell Lung Cancer or Lung Disease?
Do you have any of these conditions: carcinoma lung or nsclc or Non-Small Cell Lung Cancer or Lung Disease or Bronchial Neoplasm or Lung Cancer or lung carcinoma or Pulmonary Disease or L...?
Do you have any of these conditions: Non-Small Cell Lung Cancer or Lung Cancer or nsclc or Lung Neoplasm or Lung Disease or lung carcinoma or carcinoma lung or Pulmonary Disease or Bronch...?
Do you have any of these conditions: Non-Small Cell Lung Cancer or Pulmonary Disease or carcinoma lung or lung carcinoma or Bronchial Neoplasm or Lung Disease or nsclc or Lung Cancer or L...?
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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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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