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

Last updated: November 11, 2024
Sponsor: Prestige Biopharma Limited
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lung Cancer

Non-small Cell Lung Cancer

Cancer

Treatment

Bevacizumab

HD204

Paclitaxel

Clinical Study ID

NCT03390686
SAMSON-II
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥ 18 years

  • ECOG performance status of 0-1

  • Histologically-confirmed metastatic or recurrent non-squamous non-small cell lungcancer

  • At least one measurable lesion according to RECIST v1.1.

  • Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratoryand clinical parameters

Exclusion

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 formetastatic or recurrent disease of NSCLC.

Study Design

Total Participants: 650
Treatment Group(s): 4
Primary Treatment: Bevacizumab
Phase: 3
Study Start date:
November 15, 2019
Estimated Completion Date:
April 30, 2025

Study 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.

Connect with a study center

  • Alexandrov Cancer Center

    Minsk, 223040
    Belarus

    Site Not Available

  • MHAT "Dr. Tota Venkova", AD

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431
    Bulgaria

    Site Not Available

  • CHC Osijek

    Osijek, Osijecko-baranjska 31000
    Croatia

    Site Not Available

  • LTD "High Technology Hospital Medcenter"

    Batumi, 6010
    Georgia

    Site Not Available

  • Institute of Clinical Oncology

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Interbalkan Hospital

    Thessaloníki, Asklipiou 10 57001
    Greece

    Site Not Available

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045
    Hungary

    Site Not Available

  • Nirmal Hospital Department of Oncology

    Sūrat, Gujarat 395002
    India

    Site Not Available

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra 422002
    India

    Site Not Available

  • Riga East University Hospital Latvian Oncology centre

    Riga,
    Latvia

    Site Not Available

  • HRPZ II

    Kota Bharu, Kelantan 15586
    Malaysia

    Site Not Available

  • PPUKM

    Kuala Lumpur, 56000
    Malaysia

    Site Not Available

  • Asian Hospital and Medical Center

    Muntinlupa, 1781
    Philippines

    Site Not Available

  • St. Luke's Medical Center

    Quezon City, 1102
    Philippines

    Site Not Available

  • Magodend Szpital Elblaska

    Warszawa, 01748
    Poland

    Site Not Available

  • MEDSI

    Moscow, Otradnoye 143422
    Russian Federation

    Site Not Available

  • Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • IPD of Vojvodina

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Nemocnica na okraji mesta, n.o.

    Partizánske, 95801
    Slovakia

    Site Not Available

  • Maharaj Nakorn Chiang Mai

    Chiang Mai, Muang 50200
    Thailand

    Site Not Available

  • Acibadem Adana Hospital

    Adana, 01060
    Turkey

    Site Not Available

  • Oncology Dispensary

    Odessa, 65055
    Ukraine

    Site Not Available

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