For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Aged ≥ 18 years
  2. ECOG performance status of 0-1
  3. Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer
  4. At least one measurable lesion according to RECIST v1.1.
  5. Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
  2. Sensitizing EGFR mutations or ALK rearrangements
  3. Increased risk of bleeding determined by investigator based on radiographic / clinical findings
  4. History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Lung Cancer,Non-small Cell Lung Cancer

Age (in years)

18+

Phase

Phase 3

Participants needed

650

Est. Completion Date

Jul 31, 2024

Treatment type

Interventional


Sponsor

Prestige Biopharma Limited

ClinicalTrials.gov identifier

NCT03390686

Study number

SAMSON-II

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