Non-Small Cell Lung CancerORTUSNCT02321046
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).
An observational study of Non-Small Cell Lung Cancer, run by AstraZeneca at 26 sites in Russia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 26 participants
- Where
- 26 sitesRussia
- Study dates
- 2 Sep 2015to 28 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Russia26 sites
Research Site
Arkhangelsk
Research Site
Barnaul
Research Site
Chelyabinsk
Research Site
Irkutsk
Research Site
Kemerovo
Research Site
Khabarovsk
Research Site
Khanti-Manskiysk, Russia
Research Site
Kirov
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novisibirsk, Russia
Research Site
Novosibirsk
Research Site
Obninsk
Research Site
Omsk
Research Site
Orenburg
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Tambov
Research Site
Tomsk
Research Site
Ufa
Research Site
Vladivostok
Research Site
Volgograd
Research Site
Yuzhno-Sakhalinsk
About this study
Official title: 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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Epidermal growth factor receptor, EGFR
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
Measured: up to 18 months
Secondary outcomes (5)
Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.
Measured: up to 18 months
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
Measured: 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
Measured: up to 18 months
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
Measured: up to 18 months
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
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study start2 Sep 2015
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Bedenkov, MCMD, Study director, AstraZenecaKonstantin Lactionov, Professor, Principal investigator, Russian Cancer Research Center named after N.N.BlokhinIrina Demidova, PHD, Principal investigator, Moscow City Clinical Cancer Hospital #62
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321046
- Sponsor's protocol ID
- D133FR00101
- Acronym
- ORTUS
- Status last verified
- Jun 2020
- First submitted
- 27 Nov 2014
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An epidemiOlogy Study to deteRmine the Prevalence of EGFR muTations in RUSsian Patients With Advanced NSCLC (ORTUS)
- ClinicalTrials.gov ID
- NCT02321046
- Acronym / sponsor ID
- ORTUS / D133FR00101
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Epidermal growth factor receptor, EGFR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment
Time frame: up to 18 months
5 secondary outcomes
Patient characteristics: Gender. Age. Race, ethnicity. Smoking habits. Family history of NSCLC.
Time frame: up to 18 months
Disease information/diagnostic procedures
Time frame: 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
Characteristics of the 1st line and subsequent lines of antitumor therapy
Time frame: up to 18 months
Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase)
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Bedenkov, MCMD study director
AstraZeneca
Konstantin Lactionov, Professor principal investigator
Russian Cancer Research Center named after N.N.Blokhin
Irina Demidova, PHD principal investigator
Moscow City Clinical Cancer Hospital #62
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by AstraZeneca at 26 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EGFR mutations (EGFR del746-750, EGFR L858R, EGFR T790M) rate in cytology and plasma samples prior to treatment (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.