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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

Primary Purpose

Lung Cancer, Non-small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bevacizumab
HD204
Carboplatin
Paclitaxel
Sponsored by
Prestige Biopharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Alexandrov Cancer Center
  • MHAT "Dr. Tota Venkova", AD
  • CHC Osijek
  • LTD "High Technology Hospital Medcenter"
  • Institute of Clinical Oncology
  • Interbalkan Hospital
  • Tudogyogyintezet Torokbalint
  • HCG Manavata Cancer Centre
  • Riga East University Hospital Latvian Oncology centre
  • HRPZ II
  • Asian Hospital and Medical Center
  • Magodend Szpital Elblaska
  • MEDSI
  • IPD of Vojvodina
  • Nemocnica na okraji mesta, n.o.
  • Maharaj Nakorn Chiang Mai
  • Acibadem Adana Hospital
  • Oncology Dispensary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HD204 (Bevacizumab biosimilar)

Avastin (Bevacizumab)

Arm Description

HD204 + Carboplatin/Paclitaxel

Avastin® + Carboplatin/Paclitaxel

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) at Week 18
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 28, 2017
Last Updated
September 14, 2023
Sponsor
Prestige Biopharma Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03390686
Brief Title
A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prestige Biopharma Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HD204 (Bevacizumab biosimilar)
Arm Type
Experimental
Arm Description
HD204 + Carboplatin/Paclitaxel
Arm Title
Avastin (Bevacizumab)
Arm Type
Active Comparator
Arm Description
Avastin® + Carboplatin/Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
15 mg/kg IV every 3 weeks on Day 1
Intervention Type
Drug
Intervention Name(s)
HD204
Other Intervention Name(s)
Bevacizumab
Intervention Description
15 mg/kg IV every 3 weeks on Day 1
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) at Week 18
Description
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.
Time Frame
18 weeks from randomization
Secondary Outcome Measure Information:
Title
ORR at Week 6
Description
Response at Week 6 will be evaluated by CIR to show the pattern of response
Time Frame
6 weeks from randomization
Title
ORR at Week 12
Description
Response at Week 12 will be evaluated by CIR to show the pattern of response
Time Frame
12 weeks from randomization
Title
ORR at Week 18 adjusted on dose intensity
Description
To compare ORR at Week 18 adjusted on dose intensity between treatment groups
Time Frame
18 weeks from randomization
Title
Duration of Response
Description
DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject
Time Frame
from documented tumour response until disease progression up to 12 months from randomisation
Title
Progression Free Survival
Description
PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation
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
Title
Overall Survival (OS)
Description
OS defined as the time from Day 1 of therapy until death from any cause
Time Frame
From the date of randomisation to the date of death up to 12 months from randomisation
Title
Change in tumour burden from baseline
Description
Measured by the sum of longest diameters (SLD) of the target lesions
Time Frame
Up to 52 weeks from baseline
Title
Incidence of Treatment-related Adverse Events using CTCAE v5.0
Description
After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them.
Time Frame
From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks
Title
Anti-Drug Antibodies (Immunogenicity)
Description
Incidence of anti-drug (bevacizumab) antibodies (ADA)
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)
Title
Neutralizing Antibodies (Immunogenicity)
Description
Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)
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)
Title
Trough Level [Ctrough] (Pharmacokinetics)
Description
Concentration observed 19 to 23 days after study drug administration
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)
Title
Maximum Plasma Concentration [Cmax] (Pharmacokinetics)
Description
Cmax at selected cycles
Time Frame
Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)
Title
Area under the concentration-time curve from 0 hr to time t [AUC0-t] (Pharmacokinetics)
Description
AUC0-t at selected cycles
Time Frame
Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Litha Jaison
Organizational Affiliation
Prestige Biopharma Limited
Official's Role
Study Chair
Facility Information:
Facility Name
Alexandrov Cancer Center
City
Minsk
ZIP/Postal Code
223040
Country
Belarus
Facility Name
MHAT "Dr. Tota Venkova", AD
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Facility Name
CHC Osijek
City
Osijek
State/Province
Osijecko-baranjska
ZIP/Postal Code
31000
Country
Croatia
Facility Name
LTD "High Technology Hospital Medcenter"
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Name
Institute of Clinical Oncology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Interbalkan Hospital
City
Thessaloníki
State/Province
Asklipiou 10
ZIP/Postal Code
57001
Country
Greece
Facility Name
Tudogyogyintezet Torokbalint
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
HCG Manavata Cancer Centre
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422002
Country
India
Facility Name
Riga East University Hospital Latvian Oncology centre
City
Riga
Country
Latvia
Facility Name
HRPZ II
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Facility Name
Asian Hospital and Medical Center
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
Facility Name
Magodend Szpital Elblaska
City
Warszawa
ZIP/Postal Code
01748
Country
Poland
Facility Name
MEDSI
City
Moscow
State/Province
Otradnoye
ZIP/Postal Code
143422
Country
Russian Federation
Facility Name
IPD of Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Nemocnica na okraji mesta, n.o.
City
Partizánske
ZIP/Postal Code
95801
Country
Slovakia
Facility Name
Maharaj Nakorn Chiang Mai
City
Chiang Mai
State/Province
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Acibadem Adana Hospital
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Facility Name
Oncology Dispensary
City
Odessa
ZIP/Postal Code
65055
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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

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