EGFR Gene Mutation, Non Small Cell Lung Cancer, T790M
Conditions
Keywords
Tyrosine kinase inhibitor, Osimertinib
Brief 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.
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.
Interventions
None listed
Sponsors
N.N. Blokhin National Medical Research Center of Oncology
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who discontinued therapy with Osimertinib | Through study completion, an average of 5 years | 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 |
| Proportion of patients with at least one adverse event | Through study completion, an average of 5 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Through study completion, an average of 5 years | By sex: 1. Male 2. Female Previous targeted therapy: 1. Yes 2. No Variant of mutation: 1. Exon 19 2. Exon 21 |
| Time to Treatment Discontinuation | Through study completion, an average of 5 years | By sex: 1. Male 2. Female Previous targeted therapy: 1. Yes 2. No Variant of mutation: 1. Exon 19 2. Exon 21 |
| Overall Survival | Through study completion, an average of 5 years | By sex: 1. Male 2. Female Previous targeted therapy: 1. Yes 2. No Variant of mutation: 1. Exon 19 2. Exon 21 |
| Disease Control Rate and Objective Response Rate | Through study completion, an average of 5 years | By sex: 1. Male 2. Female Previous targeted therapy: 1. Yes 2. No Variant of mutation: 1. Exon 19 2. Exon 21 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory outcome | Through study completion, an average of 5 years | 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. |
Countries
Russia
Contacts
Primary ContactKonstantin Laktionov, MD
Outcome results
None listed