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CompletedNCT01153399REASONUpdated Nov 20, 2015

A Non-interventional Study (NIS) Registry for the Epidemiological and Scientific Evaluation of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) (Stage IIIB/IV Non-small Cell Lung Cancer).

An observational study in Non Small Cell Lung Cancer, sponsored by AstraZeneca. Completed at 9 sites in Greece. Per ClinicalTrials.gov, last updated 2015-11-20.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
589
Sex
All
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Study summary

The primary objective of the study is to collect epidemiological data on EGFR mutation status [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

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Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Non Small Cell Lung Cancer
  • EGFR mutations
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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 589 is above 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
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with Non Small Cell Lung Cancer

Inclusion criteria

  1. Signed written informed consent.
  2. Female or male aged 18 years or above.
  3. Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV).
  4. Patients receiving 1st-line treatment for IIIB/IV NSCLC.
  5. Patients with known EGFR mutation status (i.e. patients must be either EGFR M+, EGFR M- or EGFR Mx).
  6. Tumour not amenable to curative surgery or radiotherapy.

Exclusion criteria

Exclusion Criteria:

  1. Mixed histology of small cell and non-small cell lung cancer.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
589 participants (actual)

Groups and cohorts

  • 1

    Patients with Non Small Cell Lung Cancer, visiting hospital oncology clinics

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What researchers measure

Primary outcomes

  1. Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity

    Time frame: Up to 2,5 years

  2. Clinico-pathological characteristics according to mutation status

    Time frame: Up to 2,5 years

Secondary outcomes

  1. Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients

    Time frame: Up to 3,5 years

  2. Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx(mutation status not evaluable) patients

    Time frame: Up to 2,5 years

  3. Clinical outcome data under real life clinical practice in all EGFR M+ patients up to disease progression (PFS, OS, DCR)

    Time frame: Up to 3,5 years

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Study locations

9 sites
  • Research Site
    Athens, Greece
  • Research Site
    Crete, Greece
  • Research Site
    Ioannina, Greece
  • Research Site
    Kavala, Greece
  • Research Site
    Larisa, Greece
  • Research Site
    Patra, Greece
  • Research Site
    Ptolemaida, Greece
  • Research Site
    Thessaloniki, Greece
  • Research Site
    Volos, Greece
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01153399
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 30, 2010
Start date
Oct 2010
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Nov 20, 2015

Study contacts

Panagiotis Pontikis
study director · AstraZeneca

Oversight

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

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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