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 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: SAMSON-II
• Study Type: interventional
• Target: 650
• Locations: 17 countries
• Sites: 18

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® in terms of efficacy, safety, pharmacokinetics and immunogenicity.

Conditions

Lung Cancer; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• ORR at Week 6

  6 weeks from randomization

• ORR at Week 12

  12 weeks from randomization

• ORR at Week 18 adjusted on dose intensity

  18 weeks from randomization

• Duration of Response

  from documented tumour response until disease progression up to 12 months from randomisation

• Progression Free Survival

  From the date of randomisation to the date of disease progression or death up to 12 months from randomisation of the last subject

Study Arms (2)

HD204 (Bevacizumab biosimilar)

EXPERIMENTAL

HD204 + Carboplatin/Paclitaxel

Drug: HD204; Drug: Carboplatin; Drug: Paclitaxel

Avastin (Bevacizumab)

ACTIVE COMPARATOR

Avastin® + Carboplatin/Paclitaxel

Drug: Bevacizumab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Bevacizumab DRUG

15 mg/kg IV every 3 weeks on Day 1

Also known as: Avastin

Avastin (Bevacizumab)

HD204 DRUG

15 mg/kg IV every 3 weeks on Day 1

Also known as: Bevacizumab

HD204 (Bevacizumab biosimilar)

Carboplatin DRUG

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

Avastin (Bevacizumab); HD204 (Bevacizumab biosimilar)

Paclitaxel DRUG

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

Also known as: Taxol

Avastin (Bevacizumab); HD204 (Bevacizumab biosimilar)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prestige Biopharma Limited: lead

Study Sites (18)

Alexandrov Cancer Center

Minsk, Minsk City, 223040, Belarus

Location

MHAT "Dr. Tota Venkova", AD

Gabrovo, 5300, Bulgaria

Location

CHC Osijek

Osijek, Osijecko-baranjska, 31000, Croatia

Location

LTD "High Technology Hospital Medcenter"

Batumi, 6010, Georgia

Location

Institute of Clinical Oncology

Tbilisi, 0159, Georgia

Location

Interbalkan Hospital

Thessaloniki, Asklipiou 10, 57001, Greece

Location

Tudogyogyintezet Torokbalint

Törökbálint, 2045, Hungary

Location

HCG Manavata Cancer Centre

Nashik, Maharashtra, 422002, India

Location

Riga East University Hospital Latvian Oncology centre

Riga, Latvia

Location

HRPZ II

Kota Bharu, Kelantan, 15586, Malaysia

Location

Asian Hospital and Medical Center

City of Muntinlupa, 1781, Philippines

Location

Magodend Szpital Elblaska

Warsaw, 01748, Poland

Location

MEDSI

Moscow, Otradnoye, 143422, Russia

Location

IPD of Vojvodina

Kamenitz, 21204, Serbia

Location

Nemocnica na okraji mesta, n.o.

Partizánske, 95801, Slovakia

Location

Maharaj Nakorn Chiang Mai

Chiang Mai, Muang, 50200, Thailand

Location

Acibadem Adana Hospital

Adana, 01060, Turkey (Türkiye)

Location

Oncology Dispensary

Odesa, 65055, Ukraine

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: November 15, 2019
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

TH (1); CR (1); SE (1); BE (1); MY (1); RU (1); PL (1); BU (1); IN (1); SL (1); HU (1); GE (2); GR (1); TU (1); UA (1); LA (1); PH (1)