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). (ORTUS)

June 26, 2020 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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
      • 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
      • 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, Russian Federation
        • Research Site
    • Russia
      • Khanti-Manskiysk, Russia, Russian Federation
        • Research Site
      • Novisibirsk, Russia, Russian Federation
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
Time Frame: up to 18 months
up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.
Time Frame: up to 18 months
up to 18 months
Disease information/diagnostic procedures
Time Frame: 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
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
up to 18 months
Characteristics of the 1st line and subsequent lines of antitumor therapy
Time Frame: 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
up to 18 months
Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase)
Time Frame: 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
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2015

Primary Completion (Actual)

June 28, 2019

Study Completion (Actual)

June 28, 2019

Study Registration Dates

First Submitted

November 27, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 26, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D133FR00101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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