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

NCT05314296 | Unknown DMC

• 1 other identifier: ESR-17-13290
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; T790M; EGFR Gene Mutation

Keywords

Tyrosine kinase inhibitor; Osimertinib

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Through study completion, an average of 5 years

Secondary Outcomes (4)

• Disease Control Rate and Objective Response Rate

  Through study completion, an average of 5 years

• Progression-free survival

  Through study completion, an average of 5 years

• Overall Survival

  Through study completion, an average of 5 years

• Time to Treatment Discontinuation

  Through study completion, an average of 5 years

Other Outcomes (1)

• Exploratory outcome

  Through study completion, an average of 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• N.N. Blokhin National Medical Research Center of Oncology: lead

Study Sites (1)

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, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Konstantin Laktionov, MD

CONTACT

+79031709795; lkoskos@mail.ru

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2022
• First Posted: April 6, 2022
• Study Start: June 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2021-12

Locations

RU (1)