Afatinib Osimertinib Sequencing NIS
- Sponsor
- Boehringer Ingelheim
- Study ID
- NCT03370770
- Status
- Completed
Conditions
- Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Afatinib — DRUGGILOTRIF, GIOTRIF, XOVOLTIB
- Osimertinib — DRUGon T790M resistance mutation was developed
Study Details
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)otrif®) as the first-line treatment followed by osimertinib in case the T790M resistance mutation was developed.
Key Dates
- Start date
- Dec 28, 2017
- Status verified
- Dec 2020
- Primary completion
- Nov 28, 2019
- Completion
- Nov 28, 2019
Study Design
- Enrollment
- 204 participants (actual)
Arms
- Arm: patients with EGFR mutation-positive NSCLC(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
Primary Outcome Measure
Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib [ Time Frame: Data collected from start of treatment until data entry completion, up to 96.8 months for first analysis and up to 114.1 months for the extension analysis. ]
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