Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
The primary objective of this open-label, single arm Phase II trial is to explore the
efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the
RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour
activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with
mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no
EGFR mutations.