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Clinical Trials in Poland / NCT03390686
Active, not recruiting Phase 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

NCT03390686 · tracked via the Priya Life Science Poland tracker
Sponsor
Prestige Biopharma Limited
Phase
Phase 3
Started
2019-11-15
Last updated
2025-05-31

Condition(s) studied

Lung CancerNon-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Bevacizumab →HD204 →Carboplatin →Paclitaxel →

Bevacizumab: 15 mg/kg IV every 3 weeks on Day 1

HD204: 15 mg/kg IV every 3 weeks on Day 1

Carboplatin: Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles

Paclitaxel: Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Overall Response Rate (ORR) at Week 18 — 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.

Trial sites (18)

FacilityCityRegionStatus
Alexandrov Cancer Center Minsk Minsk City
MHAT "Dr. Tota Venkova", AD Gabrovo Bulgaria
CHC Osijek Osijek Osijecko-baranjska
LTD "High Technology Hospital Medcenter" Batumi Georgia
Institute of Clinical Oncology Tbilisi Georgia
Interbalkan Hospital Thessaloniki Asklipiou 10
Tudogyogyintezet Torokbalint Törökbálint Hungary
HCG Manavata Cancer Centre Nashik Maharashtra
Riga East University Hospital Latvian Oncology centre Riga Latvia
HRPZ II Kota Bharu Kelantan
Asian Hospital and Medical Center City of Muntinlupa Philippines
Magodend Szpital Elblaska Warsaw Poland
MEDSI Moscow Otradnoye
IPD of Vojvodina Kamenitz Serbia
Nemocnica na okraji mesta, n.o. Partizánske Slovakia
Maharaj Nakorn Chiang Mai Chiang Mai Muang
Acibadem Adana Hospital Adana Turkey (Türkiye)
Oncology Dispensary Odesa Ukraine

On this site

📄 Avastin (bevacizumab) drug profile →

Other trials for the same condition

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC Active, not recruiting
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) Recruiting
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004) Recruiting
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28) Active, not recruiting
A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03390686 on ClinicalTrials.gov ↗ ← All trials in Poland