Open-Label, Randomised, Parallel Group, Multicentre, Phase III Study To Assess Efficacy, Safety and Tolerability Of Gefitinib (IRESSA) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia.

Trial Profile

Open-Label, Randomised, Parallel Group, Multicentre, Phase III Study To Assess Efficacy, Safety and Tolerability Of Gefitinib (IRESSA) Versus Carboplatin/Paclitaxel DC As 1st-Line Treatment In Selected Patients With Stage IIIB / IV NSCLC In Asia.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2017

At a glance

  • Drugs Gefitinib (Primary) ; Carboplatin; Paclitaxel
  • Indications Non-small cell lung cancer
  • Focus Biomarker; Registrational; Therapeutic Use
  • Acronyms IPASS
  • Sponsors AstraZeneca
  • Most Recent Events

    • 06 Jun 2017 Results developing model relating tumor load dynamics to a time evolving hazard of progression using data from this study presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 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
    • 13 Jul 2015 The U.S. FDA has approved gefitinib [IRESSA] 250 mg, once daily for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test. The approval is based on the data from the phase IV IFUM trial and was supported by results from this trial.
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