Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05427305
Status:
COMPLETED
Last Update Posted:
2022-06-22
First Post:
2022-06-09
Brief Title:
TAB008 Compared to Avastin in Patients With EGFR Wild-type Non-squamous Non-small Cell Lung Cancer
Sponsor:
TOT Biopharm Co Ltd
Organization:
TOT Biopharm Co Ltd
Study Overview
Official Title:
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
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 11 into TAB008 or Bevacizumab-EU groups Patients received TAB008 or bevacizumab-EU 15 mgkg intravenously plus paclitaxelcarboplatin for 4-6 cycles followed by TAB008 or bevacizumab-EU 75 mgkg 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 TumorRECIST version 11 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 11 to receive TAB008 or bevacizumab-EU 15 mgkg every three weeks for 6 cycles then 75mgkg until disease progression intolerable toxicity withdrawal of consent lost to follow up or death All patients received carboplatin area under the curve AUC50 mgmlmin and paclitaxel 175 mgm2 every three weeks for between 4 to 6 cyclesEligible subjects were randomized 11 by the Interactive Web Response System IWRS into the TAB008 group or bevacizumab-EU groupThe primary endpoint would be overall response rate ORR within the first 6 cycles of treatment determined by the independent radiology review committee IRRC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None