Lung Cancer Non-small Cell Stage IV
Conditions
Keywords
non-small cell lung cancer, egfr mutation, osimertinib
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.
Interventions
None listed
Sponsors
Hellenic Cooperative Oncology Group
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Safety profile and toxicity | through the completion of the study, up to 2 years | Rates of adverse events because of treatment with osimertinib |
| health economics | through the completion of the study, up to 2 years | description of health costs to determine cost-effectiveness of osimertinib |
| quality of life data | through the completion of the study, up to 2 years | quality of life data through EQ-5D-5L questionnaire |
Countries
Greece
Contacts
Primary ContactMaria Drizou, MD
Backup ContactMaria Moschoni
Outcome results
None listed