A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
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 Details
Contition
Lung Cancer,Non-small Cell Lung Cancer
Age (in years)
18+
Phase
PHASE3
Participants Needed
650
Est. Completion Date
Jul 31, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Prestige Biopharma Limited
ClinicalTrials.gov NCT Identifier
NCT03390686
Study Number
SAMSON-II
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