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.
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.
Study Type
OBSERVATIONAL
Enrollment
70
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, Russia
RECRUITINGProportion 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
Time frame: Through study completion, an average of 5 years
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
Time frame: Through study completion, an average of 5 years
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
Time frame: Through study completion, an average of 5 years
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
Time frame: Through study completion, an average of 5 years
Overall Survival
By sex: 1. Male 2. Female Previous targeted therapy: 1. Yes 2. No Variant of mutation: 1. Exon 19 2. Exon 21
Time frame: Through study completion, an average of 5 years
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
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Time frame: Through study completion, an average of 5 years