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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Osimertinib as First Line Therapy for Patients With Advanced EGFR Positive Non-Small Cell Lung Cancer: the Experience of the Hellenic Cooperative Oncology Group (HeCOG)

Conditions
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Lung Cancer Non-small Cell Stage IV

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| untreated patients with advanced EGFR positive non-small cell lung cancer<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, egfr mutation, osimertinib