An epidemiOlogy Study to deteRmine the Prevalence of EGFR muTations in RUSsian Patients With Advanced NSCLC (ORTUS)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Non-Small Cell Lung Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
Time Frame: up to 18 months
Secondary Outcomes
- 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)
- Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.(up to 18 months)
- Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase)(up to 18 months)
- Disease information/diagnostic procedures(up to 18 months)