Description:
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 immunogenecity.
Title
- Brief Title: A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenecity 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
Clinical Trial IDs
- ORG STUDY ID:
SAMSON-II
- NCT ID:
NCT03390686
Conditions
- Lung Cancer
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Bevacizumab | Avastin | Avastin (Bevacizumab) |
HD204 | Bevacizumab | HD204 (Bevacizumab biosimilar) |
Carboplatin | | Avastin (Bevacizumab) |
Paclitaxel | Taxol | Avastin (Bevacizumab) |
Purpose
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 immunogenecity.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
HD204 (Bevacizumab biosimilar) | Experimental | HD204 + Carboplatin/Paclitaxel | - HD204
- Carboplatin
- Paclitaxel
|
Avastin (Bevacizumab) | Active Comparator | Avastin® + Carboplatin/Paclitaxel | - Bevacizumab
- Carboplatin
- Paclitaxel
|
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Best Objective Response Rate by 24 weeks |
Time Frame: | 24 weeks from randomization |
Safety Issue: | |
Description: | Any PR or CR prior to the 24th week will be marked as response |
Secondary Outcome Measures
Measure: | 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 |
Safety Issue: | |
Description: | PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject |
Measure: | Overall Survival (OS) |
Time Frame: | from the date of randomisation to the date of death up to 12 months from randomisation of the last subject |
Safety Issue: | |
Description: | OS defined as the time from Day 1 of therapy until death from any cause |
Measure: | Duration of Response |
Time Frame: | from documented tumour response until disease progression up to 12 months from randomisation of the last subject |
Safety Issue: | |
Description: | DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject |
Measure: | Incidence of Treatment-related Adverse Events using CTCAE v4.03 |
Time Frame: | AEs will be reported from the time the informed consent form (ICF) is signed until the EOT visit. The expected EOT visit for a final subject is approximately 30 months from study initiation. |
Safety Issue: | |
Description: | After the end of treatment (EOT) visit, SAEs should be reported to the Sponsor if the Investigator becomes aware of them. |
Measure: | Trough Level [Ctrough] (Pharmacokinetics) |
Time Frame: | Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) |
Safety Issue: | |
Description: | Ctrough at selected cycles |
Measure: | Maximum Plasma Concentration [Cmax] (Pharmacokinetics) |
Time Frame: | Up to 21 weeks (Cycle 1,3,5 and 7. Each cycle is 21 days.) |
Safety Issue: | |
Description: | Cmax at selected cycles |
Measure: | Anti-Drug Antibodies (Immunogenecity) |
Time Frame: | Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.) |
Safety Issue: | |
Description: | Incidence of anti-drug (bevacizumab) antibodies (ADA) |
Measure: | Neutralizing Antibodies (Immunogenecity) |
Time Frame: | Up to 21 weeks (Cycle 1,3,5, 7 and EOT visit. Each cycle is 21 days. The expected EOT visit for a final subject is approximately 30 months from study initiation.) |
Safety Issue: | |
Description: | Incidence of anti-drug (bevacizumab) antibodies (ADA) - neutralizing antibodies (NAb) |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Prestige Biopharma Pte Ltd |
Last Updated
April 20, 2021