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Non Small Cell Lung CancerTRUSTNCT05314296

Osimertinib for Russian EGFR T790M Mutation-positive NSCLC Patients Who Progressed on or After EGFR TKI Therapy

An observational study of Non Small Cell Lung Cancer and T790M, run by N.N. Blokhin National Medical Research Center of Oncology at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to assess safety of Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression during or after therapy with a prior EGFR tyrosine kinase inhibitor (TKI), with confirmed Т790М positive mutation in EGFR gene. Read more about this study

Who is it for?
Ages 18 years and older
How many people
70 participants
Where
1 siteRussia
Study dates
1 Jun 2020to Dec 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study plans to include all the patients enrolled in an Osimertinib Early Access Program in Russia With Locally Advanced/Metastatic EGFR T790M Mutation-positive NSCLC and Prior Exposure to and progression on or after other EGFR TKI Therapy (presumably 45 to 50 subjects) and patients, who were treated with osimertinib in local clinical practice (presumably 20 to 25 subjects).

Who may be able to join

  • Participation in Osimertinib EAP and /or taking / completion therapy with Osimertinib in real clinical practice;
  • Confirmed diagnosis of IIIB (locally advanced) or IV (metastatic) stages of NSCLC with T790M EGFRm;
  • Progression of the disease that occurred during or after the therapy with first- or second-generation EGFR TKI

Who cannot join

  • Participation in any other clinical study;
  • Absence of data essential for obtaining all necessary information in full.

Trial locations and contacts

1 site in 1 country.

Konstantin Laktionov, MD contact

+79031709795

lkoskos@mail.ru

Russia1 site, 1 recruiting

  • Federal State Budgetary Institution National Medical Research Center of Oncology named after N.N. N.N. Blokhin" of the Ministry of Health of Russia

    Moscow, 115478

    Konstantin Laktionov, M.D., +79031709795, lkoskos@mail.ru

    Recruiting

Other trials in Russia

About this study

Official title: Multicenter Non-interventional Study of Osimertinib Administration in Patients With NSCLC Progression Occurred During or After Therapy With EGFR Tyrosine Kinase Inhibitors, With Confirmed Т790М Positive Mutation in EGFR Gene

The purpose of this study is to assess safety of Osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression during or after therapy with a prior EGFR tyrosine kinase inhibitor (TKI), with confirmed Т790М positive mutation in EGFR gene.

Read the detailed description

This study is a multicenter non-interventional retro- and prospective study of safety and efficacy of the Osimertinib administration in frames of Early Access Program (EAP) and real clinical practice in patients with locally advanced or metastatic non-small cell lung cancer that progressed during or after therapy with an EGFR tyrosine kinase inhibitor, with confirmed Т790М positive mutation in EGFR gene with explorative analysis of the set of mutations detected in plasma ctDNA taken after the progression on Osimertinib.

It is planned to include in the study approximately 70 patients in the Russian Federation (RF) who are participating or having completed their participation in EAP, or patients, who were treated with Osimertinib in real clinical practice.

For the patients participating in EAP and patients taking Osimertinib in real clinical practice, prospective data collection is planned after signing the informed consent form(ICF) for participation in the study. Data from those patients who completed participation in EAP or completed therapy with Osimertinib in real clinical practice will be gathered retrospectively, following the procedure of signing the ICF, or without it, if the procedure is not applicable (patient's death prior to the data collection).

Patients who are participating in EAP at the moment of inclusion into the TRUST study will receive therapy by Osimertinib at a dose of 80 mg a day orally, as a single dose. Patients will be treated according to the SmPC and local clinical regulations. Assessment of response to the therapy will be performed in accordance with RECIST 1.1.

From all patients included into the study will be performed retro- or prospective data collection of two-year-course of the disease starting from the time of first dose of Osimertinib.

For patients with progression of the disease on Osimertinib will be performed molecular-genetic testing of their plasma ctDNA at the time when the fact of the progression is registered.

During the study, each patient, for whom data will be collected prospectively, will undergo two data collection points: the first point (for signing of ICF and evaluation of eligibility criteria) and the final point, which will take place 2 years after the first dose of Osimertinib or at the time when therapy by Osimertinib is discontinued. Patients, for whom data will be collected retrospective, should underdo only the first visit for signing the ICF.

Keywords
Tyrosine kinase inhibitor, Osimertinib
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.

  1. Proportion of patients with at least one adverse event

    By sex:

    1. Male
    2. Female

    By line of treatment:

    1. First line therapy
    2. Second line of therapy

    By treatment duration:

    1. Up to a year
    2. More than a year

    By effectiveness of therapy:

    1. Progression
    2. Stabilization
    3. Negative feedback

    Previous targeted therapy:

    1. Yes
    2. No

    Variant of mutation:

    1. Exon 19
    2. Exon 21

    Measured: Through study completion, an average of 5 years

  2. Proportion of patients who discontinued therapy with Osimertinib

    By sex:

    1. Male
    2. Female

    By line of treatment:

    1. First line therapy
    2. Second line of therapy

    By treatment duration:

    1. Up to a year
    2. More than a year

    By effectiveness of therapy:

    1. Progression
    2. Stabilization
    3. Negative feedback

    Previous targeted therapy:

    1. Yes
    2. No

    Variant of mutation:

    1. Exon 19
    2. Exon 21

    Measured: Through study completion, an average of 5 years

Secondary outcomes (4)

  1. Disease Control Rate and Objective Response Rate

    By sex:

    1. Male
    2. Female

    Previous targeted therapy:

    1. Yes
    2. No

    Variant of mutation:

    1. Exon 19
    2. Exon 21

    Measured: Through study completion, an average of 5 years

  2. Progression-free survival

    By sex:

    1. Male
    2. Female

    Previous targeted therapy:

    1. Yes
    2. No

    Variant of mutation:

    1. Exon 19
    2. Exon 21

    Measured: Through study completion, an average of 5 years

  3. Overall Survival

    By sex:

    1. Male
    2. Female

    Previous targeted therapy:

    1. Yes
    2. No

    Variant of mutation:

    1. Exon 19
    2. Exon 21

    Measured: Through study completion, an average of 5 years

  4. Time to Treatment Discontinuation

    By sex:

    1. Male
    2. Female

    Previous targeted therapy:

    1. Yes
    2. No

    Variant of mutation:

    1. Exon 19
    2. Exon 21

    Measured: Through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2022
  2. Study start1 Jun 2020
  3. Primary completionSep 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
Ecologic or community
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05314296
Sponsor's protocol ID
ESR-17-13290
Acronym
TRUST
Status last verified
Dec 2021
First submitted
5 Mar 2022
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer and T790M, run by N.N. Blokhin National Medical Research Center of Oncology at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Konstantin Laktionov, MD (+79031709795, lkoskos@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with at least one adverse event (time frame: Through study completion, an average of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05314296.

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 6 Apr 2022.

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