Clinical trial · Observational
Osimertinib for Russian EGFR T790M Mutation-positive NSCLC Patients Who Progressed on or After EGFR TKI Therapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Gene Mutation | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| T790M | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Proportion of patients with at least one adverse event
- timeFrame
- Through study completion, an average of 5 years
- description
- 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
- measure
- Proportion of patients who discontinued therapy with Osimertinib
- timeFrame
- Through study completion, an average of 5 years
- description
- 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 outcomes (4)
- measure
- Disease Control Rate and Objective Response Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available