Clinical trial · Observational
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 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)-REASON STUDY.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients with Non Small Cell Lung Cancer, visiting hospital oncology clinics
Primary outcomes (2)
- measure
- Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity
- timeFrame
- Up to 2,5 years
- measure
- Clinico-pathological characteristics according to mutation status
- timeFrame
- Up to 2,5 years
Secondary outcomes (3)
- measure
- Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients
- timeFrame
- Up to 3,5 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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: 1\. Mixed histology of small cell and non-small cell lung cancer.
References
Publications (0)
Data not yet available