Afatinib Osimertinib Sequencing NIS

Study Overview
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Brief Summary
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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.

Official Title
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GioTag: Real-world Data Study on Sequential Therapy With Gi(l)Otrif®/ Afatinib as First-line Treatment Followed by Osimertinib in Patients With EGFR Mutation Positive Advanced Non-small Cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Afatinib
* Drug: Osimertinib


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with EGFR mutation-positive NSCLC<br>(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor) | Drug: Afatinib<br>* GILOTRIF, GIOTRIF, XOVOLTIB<br>Drug: Osimertinib<br>* on T790M resistance mutation was developed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib | Time on treatment, which was defined as time in months from the start date of Afatinib (Gi[l]otrif®) treatment ('start date of initial dose' for First-Line Treatment) to the end date of Osimertinib treatment (maximum between 'end date of initial dose' and the last 'end date of dose modification' for Second-Line Treatment) or death date due to any cause ('date of death'). Time on treatment (months) = Time on treatment (days)/30.4375. 'Time on treatment was analysed using Kaplan-Meier method, and the median along with two-sided 90% confidence interval was displayed using the Greenwood's formula for estimation of standard errors. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants With Different Types of Mutations After Categorisation | Different types of resistance mutations identified at the time of discontinuation of osimertinib treatment were systematically reviewed and categorised. | Data collected from start of treatment until data entry completion; up to 96.8 months. |