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Multicenter, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of MYL-1402O Compared With Avastin®, in the First-line Treatment of Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

Trial Profile

Multicenter, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of MYL-1402O Compared With Avastin®, in the First-line Treatment of Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2023

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At a glance

  • Drugs Bevacizumab (Primary) ; Carboplatin; Paclitaxel
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Mylan

Most Recent Events

  • 04 Oct 2023 Results of pooled analysis (from studies NCT02469987 and NCT04633564) to establish a population pharmacokinetic model assessing to assess pharmacokinetic linearity of MYL-1402O and Avastin across dose ranges in patients with non-squamous non-small cell lung cancer published in the European Journal of Drug Metabolism and Pharmacokinetics
  • 28 Sep 2022 According to Celltrion media release, the USFDA has approved Vegzelma, for the treatment of six types of cancer: metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer ; recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer based on totality of evidence, including this pivotal trial
  • 10 Mar 2022 This trial has been discontinued in Italy.

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