This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
520
BP102, paclitaxel, carboplatin
Avastin®, paclitaxel, carboplatin
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Objective response rate
optimal ORR at 18 weeks, independent radiographic assessment
Time frame: 18 weeks
Progression-free survival
Progression-free survival is the time from randomization to the first documented objective disease progression (PD) using RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: 41 months
Overall survival (OS)
Overall survival is defined as the time from day 1 (part 1) or from randomization (part 2) to date of death.
Time frame: 41 months
Disease Control Rate (DCR)
Based on investigator reviewed radiographic tumour assessment and death.
Time frame: 41 months
Duration of Response (DoR)
Based on investigator reviewed radiographic tumour assessment and death.
Time frame: 41 months
Quality of Life assessment using EORTC QLQ-C30
Evaluate subjects' quality of life
Time frame: 41 months
Incidence of treatment-emergent adverse events, serious adverse events
Safety analyses will be performed using the safety population, defined as all patients receiving any study drug.
Time frame: Enrollment to 28 days after permanent treatment termination
Positive rate of anti-bevacizumab antibody and its titer
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Immunogenicity evaluation
Time frame: 41 months
Positive rate of neutralizing antibody
Immunogenicity evaluation
Time frame: 41 months