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 India 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)

BevacizumabHD204CarboplatinPaclitaxel

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

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)

Facility	City	Region
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 →

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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 India