Osimertinib as 1st Line Therapy for Patients With Advanced EGFR Positive Non-Small Cell Lung Cancer

Recruiting

• Conditions: Lung Cancer Non-small Cell Stage IV

• Registration Number: NCT05127382
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

The present study will evaluate the use of osimertinib as 1st line therapy for patients with advanced EGFR positive non-small cell lung cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology.

Detailed Description

This will be an observational, multicentric, retrospective/ prospective analysis of patients with advanced EGFR positive non-small cell lung cancer that receive osimertinib as 1st line therapy. The patient data will be collected at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology during scheduled patient clinical visits, from February 2020 for a total period of three years. The biological material obtained from the patients of this analysis will be possibly used in a future translational study as an exploratory analysis.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08
• Primary Completion: 2024-12
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• men or women of 18 years or older that live in Greece
• histologically or cytologically confirmed, advanced EGFR positive non-small cell lung cancer
• untreated patients for advanced NSCLC
• patients who are expected to receive osimertinib regardless of their enrollment in the study
• signed written informed consent

Exclusion Criteria

• patients with cancer other than NSCLC that require treatment
• pretreated patients for NSCLC
• patients that receive or are expected to receive or have received an investigational drug/product/intervention

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	through the completion of the study, up to 2 years	the time from treatment initiation to either the first documented disease progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
quality of life data	through the completion of the study, up to 2 years	quality of life data through EQ-5D-5L questionnaire
Safety profile and toxicity	through the completion of the study, up to 2 years	Rates of adverse events because of treatment with osimertinib
overall survival (OS)	through the completion of the study, up to 2 years	the time from treatment initiation to patient death or last contact
overall response rate (ORR)	through the completion of the study, up to 2 years	the response rate for all enrolled population and for the response evaluable population
health economics	through the completion of the study, up to 2 years	description of health costs to determine cost-effectiveness of osimertinib
second progression-free survival (PFS2)	through the completion of the study, up to 2 years	time from treatment initiation to objective tumour progression on next-line treatment or death from any cause

Trial Locations

Locations (1)

Hellenic Cooperative Oncology Group; 🇬🇷 Athens, Greece