An epidemiOlogy Study to deteRmine the Prevalence of EGFR (Epidermal Growth Factor Receptor) muTations in RUSsian Patients With Advanced NSCLC (Non-Small Cell Lung Cancer).

An epidemiOlogy Study to deteRmine the Prevalence of EGFR muTations in RUSsian Patients With Advanced NSCLC (ORTUS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02321046

Acronym

ORTUS

Enrollment

Registered

2014-12-22

Start date

2015-09-02

Completion date

2019-06-28

Last updated

2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer, NSCLC, Epidermal growth factor receptor, EGFR

Brief summary

Detailed description

This is a multicentre, non-interventional, prospective study to be carried out in representative oncology departments / institutions in order to determine the prevalence of EGFR mutations in treatment-naive Russian patients with cytologically verified advanced NSCLC in Russia. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. It is planned to enrol approximately 300 subjects in Russian Federation. Approximately 60 EGFR m+ (mutation-positive) patients will be followed for 1.5 years. EGFR mutations rate before treatment in cytology and plasma samples in treatment-naive patients with advanced NSCLC in Russia is considered as the primary outcome variable in this study.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Cytologically verified advanced (stages IIIB - IV) nonsquamous (adenocarcinoma, large cell carcinoma) and mixed subtypes of NSCLC and NSCLC-NOS), diagnosed before enrolment into the study * Quality and quantity of the cytological sample material meeting the requirements of the molecular-genetic testing * No previous/ ongoing treatment for NSCLC at the moment of recruitment

Exclusion criteria

* Squamous NSCLC cytologically confirmed subtype of cancer * Any medical condition which on the opinion of the investigator may interfere the patient's participation in the study * Quality and quantity of the cytological sample material insufficient for the molecular-genetic testing

Design outcomes

Primary

Measure	Time frame
EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment	up to 18 months

Secondary

Measure	Time frame	Description
Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.	up to 18 months	—
Disease information/diagnostic procedures	up to 18 months	Date of the cytological verification of the NSCLC diagnosis. Disease stage and TNM classification. Morphological classification. Extent of the disease. Performance Status ECOG, including at diagnosis
EGFR mutations profile in cytology and/or histology (depending on the availablility of samples) and plasma samples at the time of every progression or in 1.5 year follow up in case of no progression	up to 18 months	—
Characteristics of the 1st line and subsequent lines of antitumor therapy	up to 18 months	1st line and subsequent lines of therapy treatment, therapy regimen, medicines used for therapy (drugs by INN), for EGFRm+ patients - number of cycles of antitumor therapy, onset date, end date of each line
Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase)	up to 18 months	Treatment response/ progression of disease on every line of antitumor therapy: progressive disease, partial response, stable disease and complete response according to RECIST 1.1 evaluation and/or any other clinical assessment. Death: Disease-related or for other reasons

Countries

Russia

Outcome results