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Completed

NCT Number: NCT01818947

Gefitinib Usage and Outcomes in Routine Treatment

The purpose of this study is to understand real world gefitinib usage patterns, patient characteristics and outcomes and to present these for a Caucasian population

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Elizabeth Hospital, Birmingham, United Kingdom

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About this study

A multicentre, retrospective chart review study to characterise gefitinib usage and outcomes in routine treatment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who received gefitinib first line in the UK Single Payment Access (SPA) scheme
  • Locally advanced or metastatic EGFR mutation positive NSCLC
  • Supplied with first pack of gefitinib prior to 1st January 2012

Exclusion criteria

  • Patient was treated privately (i.e. outside the NHS)
  • Gefitinib was second-line therapy following treatment failure on a prior therapy

Treatment and study plan

Primary outcomes

  1. Assessment of treatment duration, as a surrogate of Clinical Benefit (CB) in a 'Real World' population treated with gefitinib

    Time frame: 6 months

    Retrospective population [2009 to 2013]

  2. Assessment of Overall Survival (OS) in a 'Real World' population treated with gefitinib

    Time frame: 6 months

    Retrospective population [2009 to 2013]

Secondary outcomes

  1. Assessment of Overall Survival (OS) in the subgroup of patients of Caucasian ethnicity and in the subgroup of patients treated with gefitinib for at least 3 months

    Time frame: 6 months

    Retrospective population [2009 to 2013]

  2. Assessment of Treatment duration in the subgroup of patients of Caucasian ethnicity and in the subgroup of patients treated with gefitinib for at least 3 months

    Time frame: 6 months

    Retrospective population [2009 to 2013]

  3. Characteristics of patients treated with gefitinib for all patients and stratified by whether gefitinib discontinued treatment before or after three months

    Time frame: 6 months

    Retrospective population [2009 to 2013]

  4. Description of treatment patterns in patients treated with gefitinib (prior chemo, treatment breaks, treatment on discontinuation)

    Time frame: 6 months

    Retrospective population [2009 to 2013]

  5. Duration of treatment in patients stratified by age, gender, stage and performance status.

    Time frame: 6 months

    Retrospective population [2009 to 2013]

  6. Overall Survival (OS) in patients stratified by age, gender, stage and performance status.

    Time frame: 6 months

    Retrospective population [2009 to 2013]

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicentre, Retrospective Chart Review Study to Characterise Gefitinib Usage and Outcomes in Routine Treatment

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 27, 2013
Registry last updated
Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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