Afatinib Osimertinib Sequencing NIS

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

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.

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)