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).

NCT02321046 | Completed

• 1 other identifier: D133FR00101
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 26

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer, NSCLC, Epidermal growth factor receptor, EGFR

Outcome Measures

Primary Outcomes (1)

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

  up to 18 months

Secondary Outcomes (5)

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

  up to 18 months

• Disease information/diagnostic procedures

  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

  up to 18 months

• Characteristics of the 1st line and subsequent lines of antitumor therapy

  up to 18 months

• Clinical outcome/Patient response (for EGFRm+ patients who entered observation phase)

  up to 18 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (26)

Research Site

Khanti-Manskiysk, Russia, Russia

Location

Research Site

Novisibirsk, Russia, Russia

Location

Research Site

Arkhangelsk, Russia

Location

Research Site

Barnaul, Russia

Location

Research Site

Chelyabinsk, Russia

Location

Research Site

Irkutsk, Russia

Location

Research Site

Kemerovo, Russia

Location

Research Site

Khabarovsk, Russia

Location

Research Site

Kirov, Russia

Location

Research Site

Krasnodar, Russia

Location

Research Site

Krasnoyarsk, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nizhny Novgorod, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Obninsk, Russia

Location

Research Site

Omsk, Russia

Location

Research Site

Orenburg, Russia

Location

Research Site

Rostov-on-Don, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Samara, Russia

Location

Research Site

Tambov, Russia

Location

Research Site

Tomsk, Russia

Location

Research Site

Ufa, Russia

Location

Research Site

Vladivostok, Russia

Location

Research Site

Volgograd, Russia

Location

Research Site

Yuzhno-Sakhalinsk, Russia

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Cytology and plasma samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alexander Bedenkov, MCMD

  AstraZeneca

  STUDY DIRECTOR

• Konstantin Lactionov, Professor

  Russian Cancer Research Center named after N.N.Blokhin

  PRINCIPAL INVESTIGATOR

• Irina Demidova, PHD

  Moscow City Clinical Cancer Hospital #62

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 22, 2014
• Study Start: September 2, 2015
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: June 29, 2020

Record last verified: 2020-06

Locations

RU (26)