ClinicalTrials.Veeva

Menu
The trial is taking place at:
M

Manavata Clinical Research Institute | HCG Manavata Cancer Centr

Veeva-enabled site

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

P

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

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

Trial contacts and locations

18

Loading...

Central trial contact

Litha Jaison

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems