An observational study in Lung Cancer Non-small Cell Stage IV, sponsored by Hellenic Cooperative Oncology Group. Status unknown at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by Hellenic Cooperative Oncology Group · Observational
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.
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 40 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Hellenic Cooperative Oncology Group is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
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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
Exclusion Criteria:
progression-free survival (PFS)
the time from treatment initiation to either the first documented disease progression or death from any cause
Time frame: through the completion of the study, up to 2 years
overall survival (OS)
the time from treatment initiation to patient death or last contact
Time frame: 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
Time frame: through the completion of the study, up to 2 years
quality of life data
quality of life data through EQ-5D-5L questionnaire
Time frame: through the completion of the study, up to 2 years
Safety profile and toxicity
Rates of adverse events because of treatment with osimertinib
Time frame: through the completion of the study, up to 2 years
health economics
description of health costs to determine cost-effectiveness of osimertinib
Time frame: 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
Time frame: through the completion of the study, up to 2 years
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Hellenic Cooperative Oncology Group