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

Sponsor
Prestige Biopharma Limited
Study ID
NCT03390686
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    15 mg/kg IV every 3 weeks on Day 1
  • HD204 — DRUG
    15 mg/kg IV every 3 weeks on Day 1
  • Carboplatin — DRUG
    Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
  • Paclitaxel — DRUG
    Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles

Study Details

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.

Key Dates

First listed
Jan 4, 2018
Start date
Nov 15, 2019
Status verified
May 2025
Primary completion
Jul 1, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
650 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HD204 (Bevacizumab biosimilar)
    HD204 + Carboplatin/Paclitaxel
  • Active Comparator: Avastin (Bevacizumab)
    Avastin® + Carboplatin/Paclitaxel

Primary Outcome Measure

Overall Response Rate (ORR) at Week 18 [ Time Frame: 18 weeks from randomization ]

Related Studies