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).

Non-Small Cell Lung Cancer Clinical Trial

— ORTUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02321046
• Other study ID #: D133FR00101
• Status: Completed
• Start date: September 2, 2015
• Est. completion date: June 28, 2019

Study information

• Verified date: June 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Irkutsk
Russian Federation	Research Site	Kemerovo
Russian Federation	Research Site	Khabarovsk
Russian Federation	Research Site	Khanti-Manskiysk	Russia
Russian Federation	Research Site	Kirov
Russian Federation	Research Site	Krasnodar
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Novisibirsk	Russia
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Obninsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Orenburg
Russian Federation	Research Site	Rostov-on-Don
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Samara
Russian Federation	Research Site	Tambov
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Vladivostok
Russian Federation	Research Site	Volgograd
Russian Federation	Research Site	Yuzhno-Sakhalinsk

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment		up to 18 months
Secondary	Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.		up to 18 months
Secondary	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	up to 18 months
Secondary	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
Secondary	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	up to 18 months
Secondary	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	up to 18 months

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