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An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA) as First Line Treatment in Caucasian Patients, Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

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Trial Profile

An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA) as First Line Treatment in Caucasian Patients, Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Gefitinib (Primary)
  • Indications Adenosquamous carcinoma; Non-small cell lung cancer
  • Focus Therapeutic Use
  • Acronyms IFUM; IRESSA PhIV IFUM
  • Sponsors AstraZeneca

    • Most Recent Events

    • 16 Mar 2019 Results aiming to develop statistical framework to predict PFS and OS in IPASS and IFUM trial (NCT00322452 and NCT01203917) presented at the 120th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 06 Jun 2017 Results of joint model development and validation for overall survival and tumor size using patient data from NCT00322452 and NCT01203917 trials, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology
    • 02 Dec 2016 This trial was completed in France (end date: 2016-06-06), according to European Clinical Trials Database.
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