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).

NCT01153399 | Completed

• 1 other identifier: NIS-OGR-DUM-2010/1
• Study Type: observational
• Target: 589
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; EGFR mutations

Outcome Measures

Primary Outcomes (2)

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

  Up to 2,5 years

• Clinico-pathological characteristics according to mutation status

  Up to 2,5 years

Secondary Outcomes (3)

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

  Up to 3,5 years

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

  Up to 2,5 years

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

  Up to 3,5 years

Study Arms (1)

1

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Non Small Cell Lung Cancer

You may qualify if:

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

You may not qualify if:

• \. Mixed histology of small cell and non-small cell lung cancer.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Research Site

Athens, Athens, Greece

Location

Research Site

Crete, Crete, Greece

Location

Research Site

Ioannina, Ioannina, Greece

Location

Research Site

Kavala, Kavala, Greece

Location

Research Site

Larissa, Larisa, Greece

Location

Research Site

Pátrai, Patra, Greece

Location

Research Site

Ptolemaida, Ptolemaida, Greece

Location

Research Site

Thessaloniki, Thessaloniki, Greece

Location

Research Site

Volos, Volos, Greece

Location

Related Links

• CSR\_Synopsis\_NIS-OGR-DUM-2010\_1.pdf

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Panagiotis Pontikis

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 30, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

GR (9)