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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| untreated patients with advanced EGFR positive non-small cell lung cancer |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Drizou, MD | Contact | +30 2104807252 | drizoumaria@gmail.com | |
| Maria Moschoni | Contact | +30 2106912520 | m_moschoni@hecog.ondsl.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hellenic Cooperative Oncology Group | Recruiting | Athens | 11526 | Greece |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Blood samples will be collected from patients with advanced egfr positive non-small cell lung cancer
| 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 |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |