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

NCT02879097 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-08-25

No results posted yet for this study

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).

Conditions

  • Non-Small Cell Lung Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Cipla BioTec Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Tamal Raha, PhD · Cipla BioTec

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
2016-12-31
Primary Completion
2017-12-31
Completion
2018-05-31

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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 NCT02879097 on ClinicalTrials.gov