Non Small Cell Lung Cancer Clinical Trial
Official title:
An Observational Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib in Real-world Clinical Set-tings in Greece
NCT number | NCT04640870 |
Other study ID # | ??2/15 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2015 |
Est. completion date | May 2020 |
Verified date | November 2020 |
Source | Hellenic Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is an observational, non-interventional, single-country, multi center, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC) who had been treated with Afatinib at any line.
Status | Completed |
Enrollment | 59 |
Est. completion date | May 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - >18 years old - Patients diagnosed with Non-small cell lung cancer - metastatic disease - Afatinib treated in any line - EGFR mutated Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hellenic Cooperative Oncology Group |
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival | Progression Free Survival | From Day 1 of treatment with Afatinib until disease progression, death from any cause or last follow-up, whichever occurs first, up to 12 months | |
Secondary | Overall survival | Overall survival | From Day 1 of treatment with Afatinib until death from any cause or last follow-up, up to 24 months | |
Secondary | Second progression-free survival (PFS2) | Second progression-free survival (PFS2) | From the initiation of next treatment following discontinuation of Afatinib to the date of progression, death or last contact, up to 6 months | |
Secondary | Assessment of the safety profile of Afatinib | assessment of the safety profile of Afatinib | In every cycle, every 28 days |
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