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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD204 (Bevacizumab biosimilar) | Experimental | HD204 + Carboplatin/Paclitaxel |
|
| Avastin (Bevacizumab) | Active Comparator | Avastin® + Carboplatin/Paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | 15 mg/kg IV every 3 weeks on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 weeks from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| ORR at Week 6 | Response at Week 6 will be evaluated by CIR to show the pattern of response | 6 weeks from randomization |
| ORR at Week 12 | Response at Week 12 will be evaluated by CIR to show the pattern of response |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandrov Cancer Center | Minsk | Minsk City | 223040 | Belarus | ||
| MHAT "Dr. Tota Venkova", AD |
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| HD204 | Drug | 15 mg/kg IV every 3 weeks on Day 1 |
|
|
| Carboplatin | Drug | Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles |
|
| Paclitaxel | Drug | Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles |
|
|
| 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 | 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 | 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 | 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 | 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 | 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. | 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) | 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) | 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 | 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 | 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 | Up to 21 weeks (Cycle 2 ,4 and 6. Each cycle is 21 days.) |
| Gabrovo |
| 5300 |
| Bulgaria |
| CHC Osijek | Osijek | Osijecko-baranjska | 31000 | Croatia |
| LTD "High Technology Hospital Medcenter" | Batumi | 6010 | Georgia |
| Institute of Clinical Oncology | Tbilisi | 0159 | Georgia |
| Interbalkan Hospital | Thessaloniki | Asklipiou 10 | 57001 | Greece |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| HCG Manavata Cancer Centre | Nashik | Maharashtra | 422002 | India |
| Riga East University Hospital Latvian Oncology centre | Riga | Latvia |
| HRPZ II | Kota Bharu | Kelantan | 15586 | Malaysia |
| Asian Hospital and Medical Center | City of Muntinlupa | 1781 | Philippines |
| Magodend Szpital Elblaska | Warsaw | 01748 | Poland |
| MEDSI | Moscow | Otradnoye | 143422 | Russia |
| IPD of Vojvodina | Kamenitz | 21204 | Serbia |
| Nemocnica na okraji mesta, n.o. | Partizánske | 95801 | Slovakia |
| Maharaj Nakorn Chiang Mai | Chiang Mai | Muang | 50200 | Thailand |
| Acibadem Adana Hospital | Adana | 01060 | Turkey (Türkiye) |
| Oncology Dispensary | Odesa | 65055 | Ukraine |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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