Clinical trial NCT05127382: Osimertinib as 1st Line Therapy for Patients With Advanced EGFR Positive Non-Small Cell Lung Cancer
Official title: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer Non-small Cell Stage IV
Keywords: non-small cell lung cancer
egfr mutation
osimertinib
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with advanced EGFR positive non-small cell lung cancer that receive osimertinib as 1st line therapy and are treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology

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.

Eligibility criteria: 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

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: through the completion of the study, up to 2 years
Secondary outcomes:
measure: overall survival (OS)
timeFrame: through the completion of the study, up to 2 years
measure: overall response rate (ORR)
timeFrame: through the completion of the study, up to 2 years
measure: quality of life data
timeFrame: through the completion of the study, up to 2 years
measure: Safety profile and toxicity
timeFrame: through the completion of the study, up to 2 years
measure: health economics
timeFrame: through the completion of the study, up to 2 years
measure: second progression-free survival (PFS2)
timeFrame: through the completion of the study, up to 2 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hellenic Cooperative Oncology Group
Study officials:
References: