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

May 27, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prestige Biopharma Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 4, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Lung Cancer

Clinical Trials on Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings