There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.
Description: Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.Measure: Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib Time: Up to 98 days
Description: Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).Measure: Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term) Time: Up to 98 days
Description: Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.Measure: Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs) Time: Up to 98 days
Single Group Assignment
There is one SNP
An Open-label, Single-arm Phase IV Study of Afatinib in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Who Have Poor Performance Status and Whose Tumors Have the Common Epidermal Growth Factor Receptor (EGFR) Mutations, Exon 19 Deletions or Exon 21(L858R) Substitution Mutations. --- L858R ---
The staging is based on American Joint Committee on Cancer (AJCC) Tumor Node Metastatic (TNM) classification of malignant tumors, 7th edition - Evidence of common EGFR activating mutations (Del 19 and/or L858R) - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or 3 - Adequate organ function, defined as all of the following: - Absolute neutrophil count (ANC) > 1500 / mm3 - Platelet count >75,000 / mm3. --- L858R ---