Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or m

Conditions

Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer

Keywords

EGFR mutation ,newly diagnosed NSCLC, locally advanced or metastatic NSCLC

Brief summary

The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) 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).

Detailed description

An NIS Registry for the Epidemiological and Scientific evaluation of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC (stage IIIB/IV non-small cell lung cancer)

Schuette W, Schirmacher P, Eberhardt WEE, Dietel M, Zirrgiebel U, Muehlenhoff L, Thomas M.

2018-02-0510 citations

10.1186/s12885-018-4032-3

EGFR mutation status and first-line treatment in patients with stage III/IV non-small cell lung cancer in Germany: an observational study.

Schuette W, Schirmacher P, Eberhardt WE, Fischer JR, von der Schulenburg JM, Mezger J, Schumann C, Serke M, Zaun S, Dietel M, Thomas M.

2015-06-1228 citations

10.1158/1055-9965.epi-14-1149

Overall survival (OS) in patients with EGFR-mutated new diagnosed stage IIIB/IV NSCLC in addiction of exon 19, 18/20 and 21 mutation and in addiction of treatment with tyrosine kinase inhibitor (TKI) or chemotherapy: A subgroup analysis of the REASON trial.

Wolfgang Schuette, Timo Behlendorf, Peter Schirmacher, Wilfried Eberhardt, Manfred Dietel et al. (8 authors)

Journal of Clinical Oncology2015-05-201 citations

10.1200/jco.2015.33.15_suppl.e19001

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Mixed histology of small cell and non-small cell lung cancer

Design outcomes

Primary

Measure	Time frame
The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics	Days 1-10

Secondary

Measure	Time frame
To collect real-life clinical outcome data in all EGFR M+ patients up to and including progression.To collect real-life pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients.	Study Days 21-30

Countries

Germany

Outcome results