BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) 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 EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected
according to the following scheme:
- Forty (40) 1st line patients
- Thirty (30) 2nd line patients Patients entered into the trial will be treated and
followed until death or lost to follow-up. Additional information will be obtained on
the safety profile and PK analysis of BIBW 2992.