ORTUS: 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).
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment [up to 18 months]
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Quality and quantity of the cytological sample material meeting the requirements of the molecular-genetic testing
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No previous/ ongoing treatment for NSCLC at the moment of recruitment
Exclusion Criteria:
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Squamous NSCLC cytologically confirmed subtype of cancer
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Any medical condition which on the opinion of the investigator may interfere the patient's participation in the study
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Quality and quantity of the cytological sample material insufficient for the molecular-genetic testing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Khanti-Manskiysk | Russia | Russian Federation | |
| 2 | Research Site | Novisibirsk | Russia | Russian Federation | |
| 3 | Research Site | Arkhangelsk | Russian Federation | ||
| 4 | Research Site | Barnaul | Russian Federation | ||
| 5 | Research Site | Chelyabinsk | Russian Federation | ||
| 6 | Research Site | Irkutsk | Russian Federation | ||
| 7 | Research Site | Kemerovo | Russian Federation | ||
| 8 | Research Site | Khabarovsk | Russian Federation | ||
| 9 | Research Site | Kirov | Russian Federation | ||
| 10 | Research Site | Krasnodar | Russian Federation | ||
| 11 | Research Site | Krasnoyarsk | Russian Federation | ||
| 12 | Research Site | Moscow | Russian Federation | ||
| 13 | Research Site | Nizhniy Novgorod | Russian Federation | ||
| 14 | Research Site | Novosibirsk | Russian Federation | ||
| 15 | Research Site | Obninsk | Russian Federation | ||
| 16 | Research Site | Omsk | Russian Federation | ||
| 17 | Research Site | Orenburg | Russian Federation | ||
| 18 | Research Site | Rostov-on-Don | Russian Federation | ||
| 19 | Research Site | Saint-Petersburg | Russian Federation | ||
| 20 | Research Site | Samara | Russian Federation | ||
| 21 | Research Site | Tambov | Russian Federation | ||
| 22 | Research Site | Tomsk | Russian Federation | ||
| 23 | Research Site | Ufa | Russian Federation | ||
| 24 | Research Site | Vladivostok | Russian Federation | ||
| 25 | Research Site | Volgograd | Russian Federation | ||
| 26 | Research Site | Yuzhno-Sakhalinsk | Russian Federation |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Alexander Bedenkov, MCMD, AstraZeneca
- Principal Investigator: Konstantin Lactionov, Professor, Russian Cancer Research Center named after N.N.Blokhin
- Principal Investigator: Irina Demidova, PHD, Moscow City Clinical Cancer Hospital #62
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- D133FR00101