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

NCT05427305 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2022-06-22

No results posted yet for this study

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.

Conditions

  • Efficacy

Interventions

DRUG

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

DRUG

Bevacizumab

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

Sponsors & Collaborators

  • BioDlink Biopharm Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • min liu, doctor · No120changyang street ,Suzhou Industrial Park, Jiangsu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2020-03-24
Completion
2020-03-24

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05427305 on ClinicalTrials.gov