N/A
Completed N=204
Afatinib Osimertinib Sequencing NIS
Source: ClinicalTrials.gov NCT03370770 ↗Enrolled (actual)
204
Serious AEs
15.8%
Results posted
Dec 2020
Primary outcomePrimary: Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib — 27.6; 27.7 Months
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)otrif®) as the first-line treatment followed by osimertinib in case the T790M resistance mutation was developed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib |
27.6; 27.7 | — |
| SECONDARY The Percentage of Participants With Different Types of Mutations After Categorisation |
69.2; 20.5; 10.3 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03370770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.