NCT03390686Active, not recruitingPhase 3
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 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
Source: ClinicalTrials.gov · Last updated 31 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 650 (actual)
- First submitted
- 28 Dec 2017
- Start date
- 15 Nov 2019
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Prestige Biopharma Limited
- Diseases
- Lung cancer
- NCT number
- NCT03390686
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 650
- From 15 Nov 2019 to the primary completion date, 1 Jul 2024
- 18 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Sensitizing EGFR mutations or ALK rearrangements
Other
- Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MHAT "Dr. Tota Venkova", AD Coordinator of this site? Confirm its status | Gabrovo | Bulgaria | Unknown status |
| Alexandrov Cancer Center Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| LTD High Technology Hospital Medcenter Coordinator of this site? Confirm its status | Batumi | Georgia | Unknown status |
| Institute of Clinical Oncology Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Interbalkan Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| CHC Osijek Coordinator of this site? Confirm its status | Osijek | Croatia | Unknown status |
| Tudogyogyintezet Torokbalint Coordinator of this site? Confirm its status | Törökbálint | Hungary | Unknown status |
| HCG Manavata Cancer Centre Coordinator of this site? Confirm its status | Nashik | India | Unknown status |
| Riga East University Hospital Latvian Oncology centre Coordinator of this site? Confirm its status | Riga | Latvia | Unknown status |
| HRPZ II Coordinator of this site? Confirm its status | Kota Bharu | Malaysia | Unknown status |
| Asian Hospital and Medical Center Coordinator of this site? Confirm its status | City of Muntinlupa | Philippines | Unknown status |
| Magodend Szpital Elblaska Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| IPD of Vojvodina Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
| MEDSI Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Nemocnica na okraji mesta, n.o. Coordinator of this site? Confirm its status | Partizánske | Slovakia | Unknown status |
| Maharaj Nakorn Chiang Mai Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Oncology Dispensary Coordinator of this site? Confirm its status | Odesa | Ukraine | Unknown status |
| Acibadem Adana Hospital Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.