Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma

Study Overview
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Brief Summary
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The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC). The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.

Official Title
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J-REGISTER: Japanese REal-world Data for Treatment of Afatinib (GIotrif®) in First-line Setting and Subsequent Therapies for Patients With Advanced EGFR Mutation-positive Lung Adenocarcinoma

Conditions
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Non-squamous, Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: afatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC) Patients who were/are treated with afatinib in the first-line setting at least 20 months* prior to data entry Patients 20 years of age or older at the time of consent Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic Committee (EC)/Institutional Review Board (IRB) at each site should be followed) * Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring. Exclusion Criteria: Any contraindication to afatinib as specified in the label of Giotrif® Patients treated with afatinib within an interventional trial Patients with active brain metastases at start of afatinib treatment* * Patients with non-active brain metastases (asymptomatic state) are eligible.

Ages Eligible for Study
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Minimum Age: 20 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 treated with afatinib<br> | Drug: afatinib<br>* afatinib<br>* Other names: Giotrif®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on Treatment (TOT) with afatinib in first-line TOT (TOT1) | This will be assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause. | up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOT from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause |  | up to 48 months | 
| TOT from start of the second-line treatment until end of the second-line treatment or death by any case (TOT2) |  | up to 48 months | 
| overall survival |  | at month 18 and at month 36 | 
| survival rate |  | at month 18 and at month 36 | 
| time to initial dose reduction of afatinib |  | up to 48 months | 
| proportion of patients with dose modifications of afatinib |  | up to 48 months |