Status:
ACTIVE_NOT_RECRUITING
A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients
Lead Sponsor:
Prestige Biopharma Limited
Conditions:
Lung Cancer
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
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 efficac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT03390686
Start Date
November 15 2019
End Date
December 1 2025
Last Update
May 31 2025
Active Locations (18)
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1
Alexandrov Cancer Center
Minsk, Minsk City, Belarus, 223040
2
MHAT "Dr. Tota Venkova", AD
Gabrovo, Bulgaria, 5300
3
CHC Osijek
Osijek, Osijecko-baranjska, Croatia, 31000
4
LTD "High Technology Hospital Medcenter"
Batumi, Georgia, 6010