NCT05427305

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

Bevacizumab Biosimilar Candidate TAB008 Compared to Avastin® in Patients With Locally Advanced, Metastatic EGFR Wild-type Non-squamous Non-small Cell Lung Cancer: a Randomized, Double-blind, Multicenter Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: BioDlink Biopharm Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Efficacy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-10-20
• Primary completion: 2020-03-24
• Completion: 2020-03-24
• First posted: 2022-06-22
• Last updated: 2022-06-22

Locations

1 site across 1 country: China