In this randomized, double-blind, multicenter, phase III similarity study, treatment naive, EGFR wild-type, locally advanced, metastatic, or recurrent non-squamous, non-small cell, lung cancer (ns-NSCLC) patients were enrolled and randomized (1:1) into TAB008 or Bevacizumab-EU groups. Patients received TAB008 or bevacizumab-EU 15 mg/kg intravenously plus paclitaxel/carboplatin for 4-6 cycles followed by TAB008 or bevacizumab-EU 7.5 mg/kg until disease progression, unacceptable toxicity or death. The primary endpoint compared the objective response rate (ORR) within 6 cycles as read by an independent radiological review committee (IRRC). Secondary endpoints compared disease control rate (DCR) Within 6 cycles, duration of response (DoR), progression free survival (PFS), a year overall survival rate (OSR), overall survival (OS), safety, immunogenicity, and steady state pharmacokinetics.
This randomized, double-blind, equivalence study was conducted in China. Treatment naïve, EGFR wild-type (by PCR or NGS) nsNSCLC patients were enrolled. Patients had to be between 18-75 years of age; stage IIIB to IV pathology confirmed nsNSCLC; ECOG PS 0-1; have adequate organ function; no uncontrollable infectious or serious illnesses; and most importantly, measurable lesion according to Response Evaluation Criteria in Solid Tumor(RECIST) version 1.1. Major exclusion criteria included tumors invading major blood vessels, previous major cardiovascular accidents (stroke, heart attack, uncontrollable hypertension), bleeding diathesis, proteinuria; prior history of malignancy other than NSCLC. Patients underwent tumor assessment using contrast-enhanced CT scans every two cycles for the first six cycles, then every four cycles thereafter until disease progression. Eligible patients were randomized 1:1 to receive TAB008 or bevacizumab-EU 15 mg/kg every three weeks for 6 cycles, then 7.5mg/kg until disease progression, intolerable toxicity, withdrawal of consent, lost to follow up or death. All patients received carboplatin (area under the curve (AUC)=5.0 mg/ml/min) and paclitaxel (175 mg/m2) every three weeks for between 4 to 6 cycles.Eligible subjects were randomized 1:1 by the Interactive Web Response System (IWRS) into the TAB008 group or bevacizumab-EU group.The primary endpoint would be overall response rate (ORR) within the first 6 cycles of treatment determined by the independent radiology review committee (IRRC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
549
15 mg/kg every three weeks for 6 cycles,then 7.5mg/kg until disease progression, intolerable toxicity, withdrawal of consent, lost to follow up or death
15 mg/kg every three weeks for 6 cycles,then 7.5mg/kg until disease progression, intolerable toxicity, withdrawal of consent, lost to follow up or death
TOT
Suzhou, Jiangsu, China
ORR
The primary endpoint is overall response rate (ORR) within the first 6 cycles of treatment.ORR includes Complete Response Rate and Partial Response Rate.ORR will be independently evaluated by the independent radiology review committee (IRRC).
Time frame: at the end of cycle 6 (each cycle is 21 days).
Disease control rate(DCR)
Disease Control Rate is defined as the proportion of patients with complete response(CR), partial response(PR), or stable disease(SD) as defined by RECIST 1.1.
Time frame: at the end of cycle 6 (each cycle is 21 days).
Duration of Response (DoR)
DoR was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of disease progression .
Time frame: the time from the date of first documented response (CR or PR) until the first date of documented progression or death, and any participant not known to have died at the time of analysis were censored based on the last objective tumor evaluation.
PFS
PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression).
Time frame: From the date of randomization until the date of objective disease progression or death
overall survival rate(OSR) at 12 months
12-month OSR was defined as the proportion of patients who have not died at 12 months after randomization over the total number of evaluable patients.
Time frame: 12 months after date of randomization
Overall survival(OS)
The OS was defined as the time from the date of randomization until death due to any cause. Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive.
Time frame: From the time from the date of randomization until death due to any cause, assessed up to the data cut-off date.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.