Clinical trial NCT02321046: 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).
Official title: An epidemiOlogy Study to deteRmine the Prevalence of EGFR muTations in RUSsian Patients With Advanced NSCLC (ORTUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer, NSCLC, Epidermal growth factor receptor, EGFR
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-12-22
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target study population will be treatment-naive patients of both sexes, 18 years and older, with cytologically-verified advanced (stage IIIB-IV) non-squamous, mixed subtypes of NSCLC and NSCLC-NOS (Non-Small Cell Lung Cancer - Not Otherwise Specified), diagnosed before enrolment into the study, consented to participate in this non-interventional study, who visit the oncology hospitals/departments in the Russian Federation.

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.

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

Primary outcomes:
measure: EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
timeFrame: up to 18 months
Secondary outcomes:
measure: Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.
timeFrame: up to 18 months
measure: Disease information/diagnostic procedures
timeFrame: up to 18 months
measure: 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
timeFrame: up to 18 months
measure: Characteristics of the 1st line and subsequent lines of antitumor therapy
timeFrame: up to 18 months
measure: Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase)
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Khanti-Manskiysk
country: Russian Federation
facility: Research Site
state: Russia
city: Novisibirsk
country: Russian Federation
facility: Research Site
state: Russia
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Khabarovsk
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Tambov
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexander Bedenkov, MCMD
role: STUDY_DIRECTOR
affiliation: Russian Cancer Research Center named after N.N.Blokhin
name: Konstantin Lactionov, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Moscow City Clinical Cancer Hospital #62
name: Irina Demidova, PHD
role: PRINCIPAL_INVESTIGATOR
References: