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NCT02879097

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

Status unknown Phase 3 Last updated 22 August 2016
What this trial tests

Phase 3 trial testing CBT124 in Non-Small Cell Lung Carcinoma in 200 participants. Status unknown.

Timeline
1 December 2016
Primary endpoint
1 December 2017
1 May 2018

Quick facts

Lead sponsorCipla BioTec Pvt. Ltd.
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment200
Start date1 December 2016
Primary completion1 December 2017
Estimated completion1 May 2018

Drugs / interventions tested

Conditions studied

Sponsor

Cipla BioTec Pvt. Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Non-Small Cell Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own 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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Bevacizumab in Colorectal Cancer: Current Role in Treatment and the Potential of Biosimilars.
    Rosen LS, Jacobs IA, Burkes RL. · · 2017 · cited 114× · PMID 28801849 · DOI 10.1007/s11523-017-0518-1
  2. Monoclonal antibody biosimilars for cancer treatment.
    Broer LN, Knapen DG, de Groot DA, Mol PGM, et al · · 2024 · cited 4× · PMID 38974466 · DOI 10.1016/j.isci.2024.110115
  3. Biosimilar monoclonal antibodies for cancer treatment in adults.
    Galvao TF, Livinalli A, Lopes LC, Zimmermann IR, et al · · 2024 · cited 2× · PMID 39607013 · DOI 10.1002/14651858.cd013539.pub2

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Data sources for this page

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