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

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

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.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.