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NCT Number: 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).

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Khanti-Manskiysk, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment

    Time frame: up to 18 months

Secondary outcomes

  1. Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.

    Time frame: up to 18 months

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ORTUS

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2014
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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