TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer
Condition: Efficacy
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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).
    

Intervention name(s): TAB008; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): 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
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment