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

Boehringer Ingelheim

Status: Completed

Conditions: Non-squamous, Non-Small Cell Lung Cancer

Treatments: Drug: afatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04795245

1200-0322

Details and patient eligibility

About

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.

Enrollment: 805 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

805 participants in 1 patient group

patients treated with afatinib

Treatment:

Drug: afatinib