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

Prestige Biopharma

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-small Cell Lung Cancer; Lung Cancer

Treatments: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: HD204

Study type: Interventional

Funder types: Industry

Identifiers

NCT03390686

SAMSON-II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 650 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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650 participants in 2 patient groups

HD204 (Bevacizumab biosimilar)

Experimental group

Description:

HD204 + Carboplatin/Paclitaxel

Treatment:

Drug: HD204

Drug: Paclitaxel

Drug: Carboplatin

Avastin (Bevacizumab)

Active Comparator group

Description:

Avastin® + Carboplatin/Paclitaxel

Treatment:

Drug: Paclitaxel

Drug: Bevacizumab

Drug: Carboplatin