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

NCT03390686 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2025-05-31

No results posted yet for this study

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 immunogenicity.

Conditions

Interventions

DRUG

Bevacizumab

15 mg/kg IV every 3 weeks on Day 1

DRUG

HD204

15 mg/kg IV every 3 weeks on Day 1

DRUG

Carboplatin

Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles

DRUG

Paclitaxel

Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Sponsors & Collaborators

  • Prestige Biopharma Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2024-07-01
Completion
2025-12-31

Countries

  • Belarus
  • Bulgaria
  • Croatia
  • Georgia
  • Greece
  • Hungary
  • India
  • Latvia
  • Malaysia
  • Philippines
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Thailand
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03390686 on ClinicalTrials.gov