Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy
Status:
Terminated
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of
advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical
Phase II Stage IIIB or IV non-small cell lung cancer (NSCLC) Primary end point: Disease
control rate (= CR+PR and SD at 8 weeks /patients). Secondary end point: Safety (Serious
Adverse Events, Adverse Events leading to premature withdrawal, unexpected TarcevaTM related
AEs) .Correlation of EGFR expression rate (HER1) and FISH potentially predictive for
response.
An open-label, non randomized, multicenter, clinical trial of TarcevaTM as single agent The
sample size is 29 patients in 2 stages and based on Simon´s optimal 2 stage design. Stage 1
will accrue 10 patients, if less than 1 response is observed the study will stop; if more
than 1 response is observed the accrual will continue up till 29 patients. A total of 29
patients would be entered and the treatment will be declared to have sufficient activity to
deserve further attention if at least 5 patients obtain disease control.