This randomized, double-blind, multi-center phase 3 study is aimed to compare the efficacy and safety of mil60 with bevacizumab as first-line treatment when combined with standard chemotherapy (paclitaxel/carboplatin) in treatment-naive patients with advanced or recurrent non-squamous NSCLC.
This is a multicenter, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of mil60 plus paclitaxel and carboplatin versus bevacizumab plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.The primary objective of the study was to compare the Objective Response Rate according to RECIST 1.1 of mil60 in combination with paclitaxel plus carboplatin and bevacizumab plus paclitaxel plus carboplatin in the treatment of advanced or recurrent non-squamous NSCLC subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
517
15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg
15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to mil60 at 7.5mg/kg
Cancer Institute/Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking University Shenzhen Hospital
Shenzhen, China
Objective response rate
Percentage of patients with complete remission or partial response
Time frame: 24 months
Objective response rate
Percentage of patients with complete remission or partial response
Time frame: 26 months
Duration of response
Interval from the onset of a complete remission or partial response until evidence of disease progression or death
Time frame: 24 months
Progression-free survival
Interval between randomization and disease progression or death
Time frame: 24 months
Disease control rate
Percentage of patients with complete remission, partial response and stable disease
Time frame: 24 months
Overall survival
the time from randomisation to death from any cause
Time frame: 30 months
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