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

Non Small Cell Lung Cancer Clinical Trial

— TRUST  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05314296
• Other study ID #: ESR-17-13290
• Status: Recruiting
• Start date: June 1, 2020
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: N.N. Blokhin National Medical Research Center of Oncology
• Contact: Konstantin Laktionov, MD
• Phone: +79031709795
• Email: lkoskos[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participation in any other clinical study;

• Absence of data essential for obtaining all necessary information in full.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Gene Mutation
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Russian Federation	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

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Blokhin National Medical Research Center of Oncology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome	Percentage of patients who had been treated with other therapies prior to the start of therapy with Osimertinib.; Percentage of patients who previously underwent targeted therapy and other types of therapies.	Through study completion, an average of 5 years
Primary	Proportion of patients with at least one adverse event	By sex: Male; Female; By line of treatment: First line therapy; Second line of therapy; By treatment duration: Up to a year; More than a year; By effectiveness of therapy: Progression; Stabilization; Negative feedback; Previous targeted therapy: Yes; No; Variant of mutation: Exon 19; Exon 21	Through study completion, an average of 5 years
Primary	Proportion of patients who discontinued therapy with Osimertinib	By sex: Male; Female; By line of treatment: First line therapy; Second line of therapy; By treatment duration: Up to a year; More than a year; By effectiveness of therapy: Progression; Stabilization; Negative feedback; Previous targeted therapy: Yes; No; Variant of mutation: Exon 19; Exon 21	Through study completion, an average of 5 years
Secondary	Disease Control Rate and Objective Response Rate	By sex: Male; Female; Previous targeted therapy: Yes; No; Variant of mutation: Exon 19; Exon 21	Through study completion, an average of 5 years
Secondary	Progression-free survival	By sex: Male; Female; Previous targeted therapy: Yes; No; Variant of mutation: Exon 19; Exon 21	Through study completion, an average of 5 years
Secondary	Overall Survival	By sex: Male; Female; Previous targeted therapy: Yes; No; Variant of mutation: Exon 19; Exon 21	Through study completion, an average of 5 years
Secondary	Time to Treatment Discontinuation	By sex: Male; Female; Previous targeted therapy: Yes; No; Variant of mutation: Exon 19; Exon 21	Through study completion, an average of 5 years