Lung CancerPhase 3NCT03390686
A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
A Phase 3 study testing Bevacizumab, HD204 and Carboplatin in people with Lung Cancer and Non-small Cell Lung Cancer, run by Prestige Biopharma Limited at 18 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell Lung Cancer
- What is being tested?
- Bevacizumab, HD204 and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 18 sitesin 17 countries
- Study dates
- 15 Nov 2019to Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
18 sites in 17 countries.
18 sites in 17 countries
Georgia2 sites
LTD "High Technology Hospital Medcenter"
Batumi, 6010
Institute of Clinical Oncology
Tbilisi, 0159
Philippines1 site
Asian Hospital and Medical Center
City of Muntinlupa, 1781
About this study
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
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.
Read the 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.
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Being tested
- Bevacizumab, HD204, Carboplatin, Paclitaxel
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
15 mg/kg IV every 3 weeks on Day 1
HD204Drug
Also called Bevacizumab
15 mg/kg IV every 3 weeks on Day 1
CarboplatinDrug
Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
PaclitaxelDrug
Also called Taxol
Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
| Study group | Role | What they receive |
|---|---|---|
| HD204 (Bevacizumab biosimilar) | Experimental | HD204 + Carboplatin/Paclitaxel Receives: Drug: HD204; Drug: Carboplatin; Drug: Paclitaxel |
| Avastin (Bevacizumab) | Active comparator | Avastin® + Carboplatin/Paclitaxel Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 weeks from randomization
Secondary outcomes (13)
ORR at Week 6
Response at Week 6 will be evaluated by CIR to show the pattern of response
Measured: 6 weeks from randomization
ORR at Week 12
Response at Week 12 will be evaluated by CIR to show the pattern of response
Measured: 12 weeks from randomization
ORR at Week 18 adjusted on dose intensity
To compare ORR at Week 18 adjusted on dose intensity between treatment groups
Measured: 18 weeks from randomization
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
Measured: from documented tumour response until disease progression up to 12 months from randomisation
Progression Free Survival
PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation
Measured: 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)
OS defined as the time from Day 1 of therapy until death from any cause
Measured: From the date of randomisation to the date of death up to 12 months from randomisation
Change in tumour burden from baseline
Measured by the sum of longest diameters (SLD) of the target lesions
Measured: Up to 52 weeks from baseline
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.
Measured: From signing the ICF until 1 month after the last administration of treatment, i.e., up to 52 weeks
Anti-Drug Antibodies (Immunogenicity)
Incidence of anti-drug (bevacizumab) antibodies (ADA)
Measured: 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)
Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb)
Measured: 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)
Concentration observed 19 to 23 days after study drug administration
Measured: 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)
Cmax at selected cycles
Measured: 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)
AUC0-t at selected cycles
Measured: Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start15 Nov 2019
- Primary completion1 Jul 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prestige Biopharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390686
- Sponsor's protocol ID
- SAMSON-II
- Status last verified
- May 2025
- First submitted
- 28 Dec 2017
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03390686
- Acronym / sponsor ID
- SAMSON-II
- Conditions
- Lung Cancer, Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Prestige Biopharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD204 (Bevacizumab biosimilar) | Experimental | Drug: HD204, Drug: Carboplatin, Drug: PaclitaxelHD204 + Carboplatin/Paclitaxel |
| Avastin (Bevacizumab) | Active comparator | Drug: Bevacizumab, Drug: Carboplatin, Drug: PaclitaxelAvastin® + Carboplatin/Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAlso: Avastin15 mg/kg IV every 3 weeks on Day 1 | Drug | Avastin (Bevacizumab) |
| HD204Also: Bevacizumab15 mg/kg IV every 3 weeks on Day 1 | Drug | HD204 (Bevacizumab biosimilar) |
| CarboplatinCarboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles | Drug | Avastin (Bevacizumab), HD204 (Bevacizumab biosimilar) |
| PaclitaxelAlso: TaxolPaclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles | Drug | Avastin (Bevacizumab), HD204 (Bevacizumab biosimilar) |
Primary outcome
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.
13 secondary outcomes
ORR at Week 6
Time frame: 6 weeks from randomization
ORR at Week 12
Time frame: 12 weeks from randomization
ORR at Week 18 adjusted on dose intensity
Time frame: 18 weeks from randomization
Duration of Response
Time frame: 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
Overall Survival (OS)
Time frame: 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
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
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)
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)
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)
Maximum Plasma Concentration [Cmax] (Pharmacokinetics)
Time frame: 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.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bevacizumab, HD204 and Carboplatin in people with Lung Cancer and Non-small Cell Lung Cancer, run by Prestige Biopharma Limited at 18 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Georgia, Belarus, Bulgaria, Croatia, Greece and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) at Week 18 (time frame: 18 weeks from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.