This is a Phase III, randomized, double blind, multicenter, active comparator, parallel two arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1706 to EU Avastin® in patients with previously untreated advanced non-squamous non-small cell lung cancer (nsNSCLC) to demonstrate clinical equivalence of BAT1706 and EU Avastin®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
651
The First Affiliated Hospital of Xiamen University
Xiamen, China
Clinical Medical Research S.C.
Orizaba, Mexico
National Hospital Oncology
Bloemfontein, South Africa
Baskent University Ankara Hospital
Ankara, Turkey (Türkiye)
Overall Response Rate
The primary efficacy endpoint is ORR at Week 18 (ORR18) based on tumor response evaluated according to RECIST 1.1 as assessed by CIR. Each patient will be assigned to one of the following RECIST 1.1 categories based on independent CIR, irrespective of protocol deviations or missing data: CR: complete response. PR: partial response. SD: stable disease. PD: progressive disease. NE: not evaluable (insufficient data)
Time frame: Week 18
Progression Free Survival Rate
Progression free survival rate at 12 months, defined as the proportion of patients being alive without documented progression 12 months after randomization, using Kaplan-Meier method.
Time frame: 8 months,1 year and 2 years
Progression Free Survival Time
Progression free survival time defined as the time from the date of randomization to the date of documented clinical or radiological progression or death due to any cause using Kaplan-Meier method.
Time frame: 8 months,1 year and 2 years
Overall Survival Rate
Overall survival rate at 12 months, defined as the proportion of patients being alive 12 months after randomization using Kaplan-Meier method.
Time frame: 8 months,1 year and 2 years
Overall Survival Time
Overall survival time defined as the time from randomization to death of any cause using Kaplan-Meier method.
Time frame: 8 months,1 year and 2 years
Overall Response Rate
ORR at Week 6 (ORR6) and ORR at Week 12 (ORR12), based on tumor response as assessed by CIR, and best ORR of confirmed responses at end of study assessed by local radiologist/Investigator if after Week 18 according to RECIST 1.1.
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target area under the curve \[AUC\] 6 mg/mL•minute
CI Kryvyi Rih Oncological Dispensary of DRC
Kryvyi Rih, Ukraine
Time frame: Week 6 and Week 12
Duration of Response
Duration of response defined as the time from first documentation of a response (CR or PR) and the first documentation of progression (assessed by local radiologist/Investigator if after Week 18) according to RECIST 1.1.
Time frame: 8 months