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

September 14, 2023 updated by: Prestige Biopharma Limited

A Randomised, Double-blind, Parallel Group, Equivalence, Multicentre Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Patients With Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belarus
      • Minsk, Belarus, 223040
        • Alexandrov Cancer Center
  • Bulgaria
      • Gabrovo, Bulgaria, 5300
        • MHAT "Dr. Tota Venkova", AD
  • Croatia
    • Osijecko-baranjska
      • Osijek, Osijecko-baranjska, Croatia, 31000
        • CHC Osijek
  • Georgia
      • Batumi, Georgia, 6010
        • LTD "High Technology Hospital Medcenter"
      • Tbilisi, Georgia, 0159
        • Institute Of Clinical Oncology
  • Greece
    • Asklipiou 10
      • Thessaloníki, Asklipiou 10, Greece, 57001
        • Interbalkan Hospital
  • Hungary
      • Törökbálint, Hungary, 2045
        • Tudogyogyintezet Torokbalint
  • India
    • Maharashtra
      • Nashik, Maharashtra, India, 422002
        • HCG Manavata Cancer Centre
  • Latvia
      • Riga, Latvia
        • Riga East University Hospital Latvian Oncology centre
  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 15586
        • HRPZ II
  • Philippines
      • Muntinlupa, Philippines, 1781
        • Asian Hospital and Medical Center
  • Poland
      • Warszawa, Poland, 01748
        • Magodend Szpital Elblaska
  • Russian Federation
    • Otradnoye
      • Moscow, Otradnoye, Russian Federation, 143422
        • MEDSI
  • Serbia
      • Sremska Kamenica, Serbia, 21204
        • IPD of Vojvodina
  • Slovakia
      • Partizánske, Slovakia, 95801
        • Nemocnica na okraji mesta, n.o.
  • Thailand
    • Muang
      • Chiang Mai, Muang, Thailand, 50200
        • Maharaj Nakorn Chiang Mai
  • Turkey
      • Adana, Turkey, 01060
        • Acibadem Adana Hospital
  • Ukraine
      • Odessa, Ukraine, 65055
        • Oncology Dispensary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HD204 (Bevacizumab biosimilar)
HD204 + Carboplatin/Paclitaxel
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
Other Names:
  • Taxol
Drug: HD204
15 mg/kg IV every 3 weeks on Day 1
Other Names:
  • Bevacizumab
Active Comparator: Avastin (Bevacizumab)
Avastin® + Carboplatin/Paclitaxel
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
Other Names:
  • Taxol
Drug: Bevacizumab
15 mg/kg IV every 3 weeks on Day 1
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) at Week 18
Time Frame: 18 weeks from randomization
Percent patients within each treatment group who achieved complete response (CR) or partial response (PR) by the time of the Week 18 efficacy analysis in accordance with the RECIST 1.1. as assessed by CIR.
18 weeks from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR at Week 6
Time Frame: 6 weeks from randomization
Response at Week 6 will be evaluated by CIR to show the pattern of response
6 weeks from randomization
ORR at Week 12
Time Frame: 12 weeks from randomization
Response at Week 12 will be evaluated by CIR to show the pattern of response
12 weeks from randomization
ORR at Week 18 adjusted on dose intensity
Time Frame: 18 weeks from randomization
To compare ORR at Week 18 adjusted on dose intensity between treatment groups
18 weeks from randomization
Duration of Response
Time Frame: from documented tumour response until disease progression up to 12 months from randomisation
DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject
from documented tumour response until disease progression up to 12 months from randomisation
Progression Free Survival
Time Frame: From the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation
From the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject
Overall Survival (OS)
Time Frame: From the date of randomisation to the date of death up to 12 months from randomisation
OS defined as the time from Day 1 of therapy until death from any cause
From the date of randomisation to the date of death up to 12 months from randomisation
Change in tumour burden from baseline
Time Frame: Up to 52 weeks from baseline
Measured by the sum of longest diameters (SLD) of the target lesions
Up to 52 weeks from baseline
Incidence of Treatment-related Adverse Events using CTCAE v5.0
Time Frame: From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks
After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.
From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks
Anti-Drug Antibodies (Immunogenicity)
Time Frame: Up to 52 weeks (at Baseline; end of Cycle 4 [pre-dose in cycle 5]; end of Cycle 7 [pre-dose in cycle 8]; and at EOT)
Incidence of anti-drug (bevacizumab) antibodies (ADA)
Up to 52 weeks (at Baseline; end of Cycle 4 [pre-dose in cycle 5]; end of Cycle 7 [pre-dose in cycle 8]; and at EOT)
Neutralizing Antibodies (Immunogenicity)
Time Frame: Up to 52 weeks (at Baseline; end of Cycle 4 [predose in cycle 5]; end of Cycle 7 [predose in cycle 8]; and at EOT)
Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)
Up to 52 weeks (at Baseline; end of Cycle 4 [predose in cycle 5]; end of Cycle 7 [predose in cycle 8]; and at EOT)
Trough Level [Ctrough] (Pharmacokinetics)
Time Frame: Up to 52 weeks (end of Cycle 1 [predose of Cycle 2], end of Cycle 3 [predose of Cycle 4], end of Cycle 5 [predose of Cycle 6] and EOT)
Concentration observed 19 to 23 days after study drug administration
Up to 52 weeks (end of Cycle 1 [predose of Cycle 2], end of Cycle 3 [predose of Cycle 4], end of Cycle 5 [predose of Cycle 6] and EOT)
Maximum Plasma Concentration [Cmax] (Pharmacokinetics)
Time Frame: Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)
Cmax at selected cycles
Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)
Area under the concentration-time curve from 0 hr to time t [AUC0-t] (Pharmacokinetics)
Time Frame: Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)
AUC0-t at selected cycles
Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prestige Biopharma Limited

Investigators

  • Study Chair: Litha Jaison, Prestige Biopharma Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

December 28, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAMSON-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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