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CompletedNCT01818947Updated Jan 23, 2014

Gefitinib Usage and Outcomes in Routine Treatment

An observational study in Lung Cancer, sponsored by AstraZeneca. Completed at 12 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-23.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
157
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Lung Cancer

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Keywords

  • Lung cancer
  • epidermal growth factor receptor mutation
  • gefitinib
  • Iressa
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 157 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

hospital clinic

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

Exclusion Criteria:

  • Patient was treated privately (i.e. outside the NHS)
  • Gefitinib was second-line therapy following treatment failure on a prior therapy
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
157 participants (actual)

Groups and cohorts

  • Gefitinib
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What researchers measure

Primary outcomes

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

    Retrospective population \[2009 to 2013\]

    Time frame: 6 months

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

    Retrospective population \[2009 to 2013\]

    Time frame: 6 months

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

    Retrospective population \[2009 to 2013\]

    Time frame: 6 months

  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

    Retrospective population \[2009 to 2013\]

    Time frame: 6 months

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

    Retrospective population \[2009 to 2013\]

    Time frame: 6 months

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

    Retrospective population \[2009 to 2013\]

    Time frame: 6 months

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

    Retrospective population \[2009 to 2013\]

    Time frame: 6 months

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

    Retrospective population \[2009 to 2013\]

    Time frame: 6 months

07

Study locations

12 sites
  • Queen Elizabeth Hospital
    Birmingham, United Kingdom
  • Velindre Nhs Trust
    Cardiff, United Kingdom
  • Harrogate District Hospital
    Harrogate, United Kingdom
  • Leeds Teaching Hospitals
    Leeds, United Kingdom
  • Liverpool Heart and Chest Hospital
    Liverpool, United Kingdom
  • Mount Vernon Hospital Nhs Trust
    London, United Kingdom
  • Royal Marsden Hospital
    London, United Kingdom
  • University College Hospital
    London, United Kingdom
  • Christie Hospital Nhs Trust
    Manchester, United Kingdom
  • Nottingham University Hospitals Nhs Trust
    Nottingham, United Kingdom
  • Northern General Hospital
    Sheffield, United Kingdom
  • York District Hospital
    York, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01818947
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 27, 2013
Start date
Jun 2013
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Jan 23, 2014

Study contacts

Fiona Blackhall, MBCHB FRCP
principal investigator · The Christie NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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