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.
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.
Study Type
OBSERVATIONAL
Enrollment
26
Research Site
Khanti-Manskiysk, Russia, Russia
Research Site
Novisibirsk, Russia, Russia
EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
Time frame: up to 18 months
Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.
Time frame: up to 18 months
Disease information/diagnostic procedures
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
Time frame: up to 18 months
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
Time frame: up to 18 months
Characteristics of the 1st line and subsequent lines of antitumor therapy
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
Time frame: up to 18 months
Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase)
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
Time frame: up to 18 months
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Research Site
Arkhangelsk, Russia
Research Site
Barnaul, Russia
Research Site
Chelyabinsk, Russia
Research Site
Irkutsk, Russia
Research Site
Kemerovo, Russia
Research Site
Khabarovsk, Russia
Research Site
Kirov, Russia
Research Site
Krasnodar, Russia
...and 16 more locations