Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer Clinical Trial
— REASONOfficial title:
An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer (Stage IIIB/IV Non-small Cell Lung Cancer)
| Verified date | October 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Observational |
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).
| Status | Completed |
| Enrollment | 4243 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility | Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Mixed histology of small cell and non-small cell lung cancer |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Research Site | Aachen | |
| Germany | Research Site | Amberg | |
| Germany | Research Site | Ansbach | |
| Germany | Research Site | Aschaffenburg | |
| Germany | Research Site | Augsburg | |
| Germany | Research Site | Bad Berka | |
| Germany | Research Site | Ballenstedt | |
| Germany | Research Site | Bamberg | |
| Germany | Research Site | Bayreuth | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Bielefeld | |
| Germany | Research Site | Bitterfeld-Wolfen | |
| Germany | Research Site | Bochum | |
| Germany | Research Site | Bonn | |
| Germany | Research Site | Borstel | |
| Germany | Research Site | Bottrop | |
| Germany | Research Site | Braunschweig | |
| Germany | Research Site | Bremen | |
| Germany | Research Site | Bremerhaven | |
| Germany | Research Site | Celle | |
| Germany | Research Site | Chemnitz | |
| Germany | Research Site | Coswig | |
| Germany | Research Site | Cottbus | |
| Germany | Research Site | Darmstadt | |
| Germany | Research Site | Deggendorf | |
| Germany | Research Site | Dessau-Rosslau | |
| Germany | Research Site | Donaustauf | |
| Germany | Research Site | Dortmund | |
| Germany | Research Site | Dresden | |
| Germany | Research Site | Dusseldorf | |
| Germany | Research Site | Eisenach | |
| Germany | Research Site | Erlangen | |
| Germany | Research Site | Essen | |
| Germany | Research Site | Esslingen | |
| Germany | Research Site | Flensburg | |
| Germany | Research Site | Frankfurt | |
| Germany | Research Site | Freiburg | |
| Germany | Research Site | Freising | |
| Germany | Research Site | Fulda | |
| Germany | Research Site | Gerlingen | |
| Germany | Research Site | Gieben | |
| Germany | Research Site | Goslar | |
| Germany | Research Site | Gottingen | |
| Germany | Research Site | Greifenstein | |
| Germany | Research Site | Grobhansdorf | |
| Germany | Research Site | Halle | |
| Germany | Research Site | Halle-Dolau | |
| Germany | Research Site | Hamburg | |
| Germany | Research Site | Hamm | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Heidelberg | |
| Germany | Research Site | Hemer | |
| Germany | Research Site | Hof | |
| Germany | Research Site | Homburg | |
| Germany | Research Site | Immenhausen | |
| Germany | Research Site | Jena | |
| Germany | Research Site | Karlsruhe | |
| Germany | Research Site | Kassel | |
| Germany | Research Site | Kiel | |
| Germany | Research Site | Koblenz | |
| Germany | Research Site | Koln | |
| Germany | Research Site | Landshut | |
| Germany | Research Site | Leipzig | |
| Germany | Research Site | Lemgo | |
| Germany | Research Site | Leverkusen | |
| Germany | Research Site | Lostau | |
| Germany | Research Site | Lowenstein | |
| Germany | Research Site | Lubeck | |
| Germany | Research Site | Ludwigshafen | |
| Germany | Research Site | Luneburg | |
| Germany | Research Site | Lunen | |
| Germany | Research Site | Magdeburg | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Mannheim | |
| Germany | Research Site | Marburg | |
| Germany | Research Site | Minden | |
| Germany | Research Site | Moers | |
| Germany | Research Site | Mulheim | |
| Germany | Research Site | Munchen | |
| Germany | Research Site | Munnerstadt | |
| Germany | Research Site | Munster | |
| Germany | Research Site | Neuss | |
| Germany | Research Site | Nordhausen | |
| Germany | Research Site | Northeim | |
| Germany | Research Site | Nurnberg | |
| Germany | Research Site | Oberhausen | |
| Germany | Research Site | Offenbach | |
| Germany | Research Site | Offenburg | |
| Germany | Research Site | Oldenburg | |
| Germany | Research Site | Osnabruck | |
| Germany | Research Site | Ostfildern | |
| Germany | Research Site | Paderborn | |
| Germany | Research Site | Passau | |
| Germany | Research Site | Querfurt | |
| Germany | Research Site | Recklinghausen | |
| Germany | Research Site | Regensburg | |
| Germany | Research Site | Rosenheim | |
| Germany | Research Site | Rostock | |
| Germany | Research Site | Saarbrucken | |
| Germany | Research Site | Schonebeck | |
| Germany | Research Site | Solingen | |
| Germany | Research Site | Sonneberg | |
| Germany | Research Site | Stralsund | |
| Germany | Research Site | Stuttgart | |
| Germany | Research Site | Suhl | |
| Germany | Research Site | Treuenbrietzen | |
| Germany | Research Site | Trier | |
| Germany | Research Site | Tubingen | |
| Germany | Research Site | Ulm | |
| Germany | Research Site | Velbert | |
| Germany | Research Site | Villingen-Schwenningen | |
| Germany | Research Site | Volklingen | |
| Germany | Research Site | Wangen/Allgau | |
| Germany | Research Site | Weiden | |
| Germany | Research Site | Wiesbaden | |
| Germany | Research Site | Wurselen | |
| Germany | Research Site | Wurzburg | |
| Germany | Research Site | Zusmarshausen |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No |