Status:
COMPLETED
Afatinib Osimertinib Sequencing NIS
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Brief Summary
This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)ot...
Eligibility Criteria
Inclusion
- Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)
- The tumour harbours common EGFR mutations (Del19, L858R) at start of first-line treatment
- Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least 10 months prior to data entry, AND who were treated with afatinib (Gi(l)otrif®) in the first-line
- Patients treated with osimertinib within an EAP/CUP or regular clinical practice
- Age ≥ 18 years
- Signed and dated written informed consent per regulations (Exemption of a written informed consent for NIS based on existing data in countries per local regulations and legal requirements)
Exclusion
- Patients who received drug(s) other than osimertinib as the second-line treatment and/or patients who received drug(s) other than afatinib (Gi(l)otrif®) as the first-line treatment
- Patients with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)
Key Trial Info
Start Date :
December 28 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 28 2019
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT03370770
Start Date
December 28 2017
End Date
November 28 2019
Last Update
December 24 2020
Active Locations (1)
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1
Otto-Wagner Hospital
Vienna, Austria, 1140