TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer
Status:
Completed
Trial end date:
2020-03-24
Target enrollment:
Participant gender:
Summary
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.