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NCT02364999

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.

Completed Phase 3 Results posted Last updated 18 January 2019
What this trial tests

Phase 3 trial testing Bevacizumab-Pfizer in Non-Small Cell Lung Cancer in 719 participants. Completed in 1 December 2017.

Timeline
1 April 2015
Primary endpoint
1 May 2017
1 December 2017

Quick facts

Lead sponsorPfizer
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment719
Start date1 April 2015
Primary completion1 May 2017
Estimated completion1 December 2017
Sites263 locations across United States, Australia, Brazil, Bulgaria, Chile, Croatia, Czechia, France

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Non-Small Cell Lung Cancer. 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

This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.

Publications & conference data

8 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. State of the art in anti-cancer mAbs.
    Chiavenna SM, Jaworski JP, Vendrell A. · · 2017 · cited 52× · PMID 28219375 · DOI 10.1186/s12929-016-0311-y
  3. PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin<sup>®</sup>), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study.
    Reinmuth N, Bryl M, Bondarenko I, Syrigos K, et al · · 2019 · cited 40× · PMID 31338773 · DOI 10.1007/s40259-019-00363-4
  4. A phase I pharmacokinetics study comparing PF-06439535 (a potential biosimilar) with bevacizumab in healthy male volunteers.
    Knight B, Rassam D, Liao S, Ewesuedo R. · · 2016 · cited 33× · PMID 26984210 · DOI 10.1007/s00280-016-3001-2
  5. Does Biosimilar Bevacizumab Offer Affordable Treatment Options for Cancer Patients in the USA? A Budget Impact Analysis from US Commercial and Medicare Payer Perspectives.
    Yang J, Liu R, Ektare V, Stephens J, et al · · 2021 · cited 17× · PMID 33506318 · DOI 10.1007/s40258-021-00637-5
  6. Identification of cardiotoxicity related to non-small cell lung cancer (NSCLC) treatments: A systematic review.
    Chan SHY, Khatib Y, Webley S, Layton D, et al · · 2023 · cited 10× · PMID 37383708 · DOI 10.3389/fphar.2023.1137983
  7. Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin&lt;sup&gt;®&lt;/sup&gt;) in patients with advanced non-squamous non-small cell lung cancer.
    Li CSW, Sweeney K, Cronenberger C. · · 2020 · cited 10× · PMID 31768697 · DOI 10.1007/s00280-019-03946-8
  8. Efficacy and Safety of Bevacizumab Biosimilars Compared With Reference Biologics in Advanced Non-small Cell Lung Cancer or Metastatic Colorectal Cancer Patients: A Network Meta-Analysis.
    Xu X, Zhang S, Xu T, Zhan M, et al · · 2022 · cited 8× · PMID 35865968 · DOI 10.3389/fphar.2022.880090

Verify or expand the search:

Other recruiting trials for Non-Small Cell Lung Cancer

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02364999.

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