NCT02879097

Efficacy-Safety-Immunogenicity Study of CBT124&EU-sourced Avastin® in Stage 4 NSCLC

Efficacy, Safety & Immunogenicity Study of CBT124 & EU-sourced Avastin® in Combination With Carboplatin and Paclitaxel in First-line Treatment in (NSCLC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cipla BioTec Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that of Avastin® (pharmacokinetics is nested in this study for Indian patients).

Detailed description

The purpose of this study is to determine whether CBT124 and Avastin® are comparable in terms of efficacy, safety, immunogenicity; and whether the pharmacokinetics of CBT124 matches that of Avastin® (pharmacokinetics is nested in this study for Indian patients). To test the clinical equivalence in terms of efficacy and safety, a two-sided test approach based on a pre-specified range to test the null hypothesis that the proposed biosimilar is either (1) inferior to the reference product or (2) superior to the reference product based on the pre-specified equivalence margin will be used. The equivalence margins are chosen to enable detection of clinically meaningful differences in effectiveness between CBT124, candidate biosimilar bevacizumab and reference product (EU-sourced Avastin®) at the 95% confidence interval (CI). In this trial, asymmetric equivalence margins will be used, i.e., the upper (superiority) and the lower (inferiority) bounds of the equivalence margin are not symmetric. The goal is to reject the null hypothesis of non-equivalence and accept the alternative hypothesis that the two treatments (in this case, CBT124 and EU-sourced Avastin®) are equivalent (i.e., the differences between the two are not clinically and statistically meaningful). The hypothesis testing will be performed by determining if the difference in the primary end point (Objective Response Rate \[ORR\]) between the reference product (EUsourced Avastin®) and proposed biosimilar (CBT124) is within the equivalence margin at the 95% CI.

Conditions

• Non-Small Cell Lung Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	CBT124	Induction Phase: CBT124 15 mg/kg IV infusion-Day 1 of each 3-week Cycle for 6 cycles; Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles; Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles. Maintenance Phase: All the subjects who complete the induction phase and are alive at Week 19 without progression of the disease can be included in the maintenance phase and receive CBT124 (bevacizumab, 15 mg/kg, intravenous infusion on Day 1 of each 3-week Cycle) up to disease progression or unacceptable toxicity (that precludes further treatment with bevacizumab) or death.
BIOLOGICAL	EU-sourced Avastin®	Induction Phase: EU-sourced Avastin® 15 mg/kg IV infusion-Day 1 of each 3-week Cycle for 6 cycles; Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles; Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles. Maintenance Phase: All the subjects who complete the induction phase and are alive at Week 19 without progression of the disease can be included in the maintenance phase and receive CBT124 (bevacizumab, 15 mg/kg, intravenous infusion on Day 1 of each 3-week Cycle) up to disease progression or unacceptable toxicity (that precludes further treatment with bevacizumab) or death.
DRUG	Carboplatin	Induction Phase: Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles.
DRUG	Paclitaxel	Induction Phase: Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-12-01
• Completion: 2018-05-01
• First posted: 2016-08-25
• Last updated: 2016-08-25