TAB008 Compared to Avastin® in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer

Sponsor
BioDlink Biopharm Co., Ltd.
Study ID
NCT05427305
Phase
PHASE3
Status
Completed

Conditions

  • Efficacy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TAB008 — DRUG
    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
  • Bevacizumab — DRUG
    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

Study Details

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.

Key Dates

First listed
Jun 22, 2022
Start date
Oct 20, 2017
Status verified
Jun 2022
Primary completion
Mar 24, 2020
Completion
Mar 24, 2020

Study Design

Enrollment
549 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TAB008
    Eligible patients received TAB008 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.
  • Active Comparator: Bevacizumab
    Eligible patients received 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.

Primary Outcome Measure

ORR [ Time Frame: at the end of cycle 6 (each cycle is 21 days). ]

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