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
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prestige Biopharma Limited; Prestige Biopharma Ltd
• Treatments: Bevacizumab; Carboplatin; Paclitaxel

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:

• 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.