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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- progression-free survival (PFS)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
progression-free survival (PFS)
Time Frame: 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 Outcomes
- quality of life data(through the completion of the study, up to 2 years)
- Safety profile and toxicity(through the completion of the study, up to 2 years)
- overall survival (OS)(through the completion of the study, up to 2 years)
- overall response rate (ORR)(through the completion of the study, up to 2 years)
- health economics(through the completion of the study, up to 2 years)
- second progression-free survival (PFS2)(through the completion of the study, up to 2 years)