A Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in Advanced Non-squamous Non-small Cell Lung Cancer Patients

Phase 3Active Not RecruitingNCT03390686

Prestige Biopharma Limited650 enrolled

Overview

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.

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 efficacy parameters, safety profiles, pharmacokinetics and immunogenicity will be compared between HD204 and bevacizumab.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

650

Conditions

Lung Cancer Non-small Cell Lung Cancer

Interventions

BevacizumabDRUG

15 mg/kg IV every 3 weeks on Day 1

HD204DRUG

15 mg/kg IV every 3 weeks on Day 1

CarboplatinDRUG

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

Paclitaxel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (18)

Alexandrov Cancer Center

Minsk, Minsk City, Belarus

MHAT "Dr. Tota Venkova", AD

Gabrovo, Bulgaria

Outcomes

Primary Outcomes

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.

Time frame: 18 weeks from randomization

Secondary Outcomes

ORR at Week 6

Response at Week 6 will be evaluated by CIR to show the pattern of response

Time frame: 6 weeks from randomization

ORR at Week 12

Response at Week 12 will be evaluated by CIR to show the pattern of response

Time frame: 12 weeks from randomization

ORR at Week 18 adjusted on dose intensity

To compare ORR at Week 18 adjusted on dose intensity between treatment groups

Time frame: 18 weeks from randomization

Duration of Response

DoR in subjects with response from documented tumour response until disease progression up to 12 months from randomisation of the last subject

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

Progression Free Survival

PFS from the date of randomisation to the date of disease progression or death up to 12 months from randomisation

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

Overall Survival (OS)

OS defined as the time from Day 1 of therapy until death from any cause

Data from ClinicalTrials.gov

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