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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)

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ClinicalTrials.gov Identifier: NCT02321046
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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
Non-Small Cell Lung Cancer

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.

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An epidemiOlogy Study to deteRmine the Prevalence of EGFR muTations in RUSsian Patients With Advanced NSCLC (ORTUS)
Actual Study Start Date : September 2, 2015
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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



Biospecimen Retention:   Samples With DNA
Cytology and plasma samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321046


Locations
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Russian Federation
Research Site
Khanti-Manskiysk, Russia, Russian Federation
Research Site
Novisibirsk, Russia, 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
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
Sponsors and Collaborators
AstraZeneca
Investigators
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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
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02321046    
Other Study ID Numbers: D133FR00101
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Keywords provided by AstraZeneca:
Non-Small Cell Lung Cancer, NSCLC, Epidermal growth factor receptor, EGFR
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms